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250-510 Administration of SymantecTM Data Loss(R) Prevention 10.5 - BETA

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250-510 exam Dumps Source : Administration of SymantecTM Data Loss(R) Prevention 10.5 - BETA

Test Code : 250-510
Test designation : Administration of SymantecTM Data Loss(R) Prevention 10.5 - BETA
Vendor designation : Symantec
: 196 actual Questions

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Symantec Administration of SymantecTM Data

BT and Symantec to extend coverage of network site visitors and Simplify security management | killexams.com actual Questions and Pass4sure dumps

SAN FRANCISCO--(enterprise WIRE)--RSA conference – BT, probably the most world’s leading suppliers of communications capabilities and options, and Symantec, the realm’s leading cyber safety enterprise, today introduced the mixing of Symantec’s latest expertise into BT’s portfolio of managed security functions.

With this new contract, BT consumers will capitalize from enhanced visibility of incoming cyber web traffic and from simplified administration of network security and hybrid cloud infrastructure.

Two new Symantec products will complement the latest Symantec Blue Coat ProxySG carrier to bolster BT’s Managed internet protection portfolio: Symantec SSL Visibility equipment and Symantec Cloud service.

Symantec SSL Visibility equipment permits businesses to cost-simply dispose of blind spots that involve the inability of perception into encrypted facts traffic on networks. on account that about half of entire web site visitors nowadays is encrypted, this can create a capacious gap in an service provider’s safety posture. With SSL Visibility equipment, customers capitalize the visibility and manage they want over encrypted site visitors to aid design unavoidable compliance with their privacy, regulatory and suitable exhaust guidelines.

Symantec Cloud carrier offers international insurance and helps design unavoidable always-on security for consumer contraptions towards malware, viruses and advanced threats. It leverages true-time intelligence from Symantec’s global Intelligence network, the area’s largest civilian danger intelligence network, which harnesses facts from greater than 1 billion net requests, 2 billion emails, and a hundred seventy five million endpoints to update safety controls with complete probability telemetry in precise-time.

The settlement introduced nowadays likewise allows entry to the Symantec management Centre platform required for the brand new Symantec SSL Visibility equipment and Symantec Cloud service. This replaces the latest Blue Coat Director capability, to be able to continue to be supported until at the least 2020 for latest consumers.

Mike Fey, president and Chief working Officer, Symantec, noted: “increasing Symantec’s capabilities within BT’s portfolio will deliver BT consumers a finished carrier that is needed in nowadays’s cyber safety atmosphere. through offering committed SSL visibility we can fight safety threats hidden in encrypted traffic so that shoppers can headquarters of attention on essential industry priorities. And the Symantec Cloud provider allows clients to lengthen their powerful Blue Coat internet security capabilities to their cell team of workers, assisting to protect users and recommendation on any equipment and from any vicinity.”

Mark Hughes, CEO, BT protection, noted: “Monitoring community environments has become increasingly advanced over the final few years, and improving visibility of encrypted site visitors undertaking and choosing blind spots is vital for a secure and comfy business. Their constrict with Symantec helps address this hardship and is a brand new step in proposing a full, complete equipment that equips Chief counsel safety Officers with the executive tools vital to video array their networks.”

About Symantec

Symantec agency (NASDAQ: SYMC), the area’s leading cyber security company, helps agencies, governments and americans at ease their most essential statistics anywhere it lives. organizations across the world seem to Symantec for strategic, integrated options to guard against subtle assaults across endpoints, cloud and infrastructure. Likewise, a world community of more than 50 million individuals and families import on Symantec’s Norton suite of products for protection at domestic and across entire of their devices. Symantec operates probably the most world’s largest civilian cyber intelligence networks, permitting it to remark and tender protection to towards the most advanced threats. For more information, gratify talk over with www.symantec.com or join with us on fb

About BT

BT’s goal is to design exhaust of the vigour of communications to design an improved world. It is one of the world’s main suppliers of communications services and solutions, serving valued clientele in a hundred and eighty nations. Its major activities involve the availability of networked IT functions globally; local, national and international telecommunications functions to its consumers to be used at home, at toil and on the circulation; broadband, tv and web items and features; and converged fixed-mobile products and features. BT includes six consumer-dealing with lines of company: purchaser, EE, company and Public Sector, international capabilities, Wholesale and Ventures, and Openreach.

For the 12 months ended 31 March 2016, BT neighborhood’s suggested earnings become £19,042m with reported income before taxation of £3,029m.

British Telecommunications plc (BT) is a totally-owned subsidiary of BT community plc and encompasses virtually entire organizations and belongings of the BT group. BT community plc is listed on stock exchanges in London and long island.

For extra information, talk over with www.btplc.com.


Symantec: 2 Out of 3 lodges Leak Your personal particulars | killexams.com actual Questions and Pass4sure dumps

are looking to location your very own records in hazard of being compromised? without hardship ebook a inn elbowroom online and await the email affirmation.

Generic Hotel Hallway

It turns out one of the crucial riskiest issues you could accomplish to your personal records is book a inn room. this is the conclusion of Symantec after reviewing more than 1,500 lodge websites spread across 54 distinct international locations.

As Reuters stories, the overview conducted by pass of Symantec discovered that two out of every three motels will leak the booking particulars of guests. those details encompass plenary names, e mail tackle, postal handle, cellular number, credit card particulars (ultimate four digits, card category, expiration), and passport numbers. The assistance is accessible to 3rd-party web sites, advertisers, and analytics businesses.

The obvious questions are how? and why? The own facts being leaked stems specially from the style by which resorts ship affirmation emails. They typically involve a reference code, which links to entire of the reserving guidance and does not require a login to access. 1 / 4 of the hotel websites likewise don't seem to be encrypting the hyperlink, making it a imposing deal more convenient to intercept and entry the guidance.

in accordance with Symantec, that reference can be shared with over 30 different service providers, "together with gregarious networks, search engines like google and yahoo and promoting and analytics services." From the resort's factor of view, sharing the suggestions with the client in this pass is simple and smooth to do, however it naturally overlooks the security danger being posed.

Candid Wueest, essential danger researcher at Symantec, defined, "whereas it's no furtive that advertisers are tracking clients' shopping habits, during this case, the suggestions shared may enable these third-birthday celebration functions to log into a reservation, view very own particulars and even cancel the booking altogether."

If the ease with which personal tips is being shared is never caring satisfactory, the resort responses to this overview may noiseless set warning bells ringing. Symantec contacted entire of them, with the regular response time with the aid of a lodge information privacy officer taking 10 days. although, 25 % did not reply within six weeks of contact. One regular response looks to be they're, "nevertheless updating their programs to be wholly GDPR-compliant."

again in November, it was found that the personal particulars of 500 million visitors at Marriott eccentric resorts had been uncovered in a database hack. Symantec did not consist of Marriott motels in the evaluation, reinforcing the reality this looks to be an industry-broad difficulty.


Two out of three hotels accidentally leak guests' very own data: Symantec | killexams.com actual Questions and Pass4sure dumps

(Reuters) - Two out of three resort websites inadvertently leak guests’ reserving particulars and personal information to third-birthday party websites, including advertisers and analytics businesses, in accordance with analysis released with the aid of Symantec Corp on Wednesday.

The examine, which looked at greater than 1,500 inn web sites in 54 international locations that ranged from two-celebrity to 5-big designation homes, comes a few months after Marriott eccentric disclosed probably the most worst records breaches in historical past.

Symantec spoke of Marriott become no longer protected within the peer at.

Compromised personal assistance comprises plenary names, e mail addresses, credit card details and passport numbers of visitors that can be used through cybercriminals who're increasingly interested in the movements of influential company experts and government employees, Symantec pointed out.

“whereas it’s no furtive that advertisers are tracking users’ searching habits, in this case, the tips shared could enable these third-birthday celebration functions to log privilege into a reservation, view own details and even cancel the reserving altogether,” mentioned Candid Wueest, the primary researcher on the peer at.

The analysis confirmed compromises always chance when a hotel web page sends confirmation emails with a hyperlink that has direct booking counsel. The reference code attached to the link may well be shared with more than 30 distinctive carrier suppliers, together with gregarious networks, serps and promoting and analytics features.  

Wueest mentioned 25 p.c of records privacy officers on the affected hotel sites did not reply to Symantec inside six weeks when notified of the problem, and those who did took a run-of-the-mill of 10 days to respond.

“Some admitted that they are nevertheless updating their systems to be fully GDPR-compliant,” Wueest referred to, relating to Europe’s new privacy legislations, or the ordinary information insurance policy legislation, which took impact a few 12 months ago and has strict instructions on how companies may noiseless capture reliance of data leakage.

Reporting through Angela Moon; enhancing by means of Dan Grebler


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Administration of SymantecTM Data Loss(R) Prevention 10.5 - BETA

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Pathway to diabetes through attenuation of pancreatic beta cell glycosylation and glucose transport | killexams.com actual questions and Pass4sure dumps

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    Shafi, R. et al. The O-GlcNAc transferase gene resides on the X chromosome and is essential for embryonic issue cell viability and mouse ontogeny. Proc. Natl. Acad. Sci. USA 97, 5735–5739 (2000).

  • 52.

    Cousin, S.P. et al. Free fatty acid–induced inhibition of glucose and insulin-like growth factor I–induced deoxyribonucleic acid synthesis in the pancreatic β-cell line INS-1. Endocrinology 142, 229–240 (2001).


  • Rational exhaust of Opioids for Management of inveterate Nonterminal twinge | killexams.com actual questions and Pass4sure dumps

    Opioid prescribing for inveterate nonterminal twinge has increased in recent years, although evidence for its long-term effectiveness is infirm and its potential for harm is significant. Nonmedical exhaust of prescription opioids, diversion, and overdose deaths believe likewise increased sharply, sparking concern about the safety of these medications. Physicians considering initiation or continuation of opioid therapy for a patient with inveterate nonterminal twinge should first exhaust a structured approach that includes a biopsychosocial evaluation and a treatment objective that encourages patients to set and achieve functional goals. There should be a comprehensive evaluation for the occasions of pain, assessment for risk of opioid complications (including misuse and addiction), and a circumstantial treatment history, including a review of medical records and data from the condition prescription monitoring program. Opioids should be prescribed on a ordeal basis, to be continued only if progress toward functional goals is demonstrated. Long-acting morphine is the preferred initial drug, although several alternatives are available. Ongoing monitoring for safety and effectiveness is essential, including regular review of functional progress or maintenance, urine drug testing, and surveillance of data from the condition prescription monitoring program. Ineffective, unsafe, or diverted opioid therapy should be promptly tapered or stopped.

    Chronic twinge affects approximately one-third of U.S. adults, and 5 percent receive opioid treatment1; strong opioids are prescribed in up to 9 percent of entire office visits.2 Until the 1990s, physicians generally limited opioid treatment to patients with acute or cancer-related pain. However, studies showed that entire types of twinge were undertreated; as a result, twinge education, advocacy, and policy initiatives led to an extend in opioid prescribing for patients with inveterate nonterminal pain.

    More expansive prescribing of opioids for inveterate nonterminal twinge has been accompanied by increasing rates of high-dose, continuous therapy.3–6 Although some patients may capitalize from such treatment, others will believe significant physiologic and functional compromise. Continuous opioid therapy for as dinky as two weeks can produce drug tolerance in some patients. For other patients, dosages as low as 30 mg per day of morphine or its equivalent believe been shown to lower twinge thresholds and create opioid-induced hyperalgesia, in which twinge paradoxically worsens as opioid doses are increased.7–9 Many patients flavor nausea, vomiting, constipation, downhearted mood, and respiratory depression, and tolerance to these toxicities may develop slowly or not at all. A 10-year follow-up study showed that patients who capture prescription opioids believe a lower character of life and higher rates of depression and health reliance utilization.10

    Increased opioid prescribing has likewise resulted in worrying trends of misuse, abuse, and diversion for sale. Between 1997 and 2006, sales of oxycodone (Roxicodone) increased nearly eightfold, and sales of methadone increased ninefold.11 Fifteen percent of 12th graders report that they believe taken hydrocodone/acetaminophen (Vicodin) or oxycodone, usually obtained from family members or friends.11 From 2004 to 2008, visits to emergency departments for nonmedical exhaust of opioids tripled.12 The Centers for Disease Control and Prevention reported a nearly sevenfold extend in methadone-related fatalities in 2009.12 Overall, the nonmedical exhaust of controlled prescription medication now exceeds illicit drug use. These statistics believe raised grave concerns among condition and federal law enforcement, regulatory, and legislative officials, and believe sparked efforts to extend prescription oversight.13,14

    In this environment, prescribers must ensure that opioid therapy is appropriate, safe, and effective. This review provides a framework for approaching opioid therapy for patients with inveterate nonterminal pain, including patient selection; structured trials of opioid therapy; monitoring; and tapering, when indicated. More details and drill tools are available online (http://guidelines.gov/content.aspx?id=25657&search=managing+chronic+pain).15

      Enlarge      Print

    SORT: KEY RECOMMENDATIONS FOR PRACTICE Clinical recommendation Evidence rating References

    Patients with inveterate nonterminal twinge should receive a comprehensive evaluation, including assessment for potential opioid responsiveness and opioid risk.

    C

    4, 6, 18

    Chronic nonterminal twinge requires treatment of physical and psychological modalities, prescription of nonopioid analgesics, treatment of comorbid mood disorders, and restoration of sleep.

    C

    18, 19

    Tricyclic antidepressants or selective serotonin-norepinephrine reuptake inhibitors should be included in patients with inveterate nonterminal twinge with a neuropathic component.

    A

    13, 15, 20

    Opioid therapy should be avoided in patients with inveterate central or visceral twinge syndromes such as fibromyalgia, headaches, or abdominal pain.

    C

    11, 17

    Opioids should be initiated as a trial, to be continued if progress is documented toward functional goals, and if there is no evidence of complications, including misuse or diversion.

    C

    6, 15, 18

    Opioid dosages exceeding 100 mg of morphine or its equivalent may extend the risk of overdose, and should prompt consideration of tapering or referral to a twinge subspecialist.

    C

    13, 27

    SORT: KEY RECOMMENDATIONS FOR PRACTICE Clinical recommendation Evidence rating References

    Patients with inveterate nonterminal twinge should receive a comprehensive evaluation, including assessment for potential opioid responsiveness and opioid risk.

    C

    4, 6, 18

    Chronic nonterminal twinge requires treatment of physical and psychological modalities, prescription of nonopioid analgesics, treatment of comorbid mood disorders, and restoration of sleep.

    C

    18, 19

    Tricyclic antidepressants or selective serotonin-norepinephrine reuptake inhibitors should be included in patients with inveterate nonterminal twinge with a neuropathic component.

    A

    13, 15, 20

    Opioid therapy should be avoided in patients with inveterate central or visceral twinge syndromes such as fibromyalgia, headaches, or abdominal pain.

    C

    11, 17

    Opioids should be initiated as a trial, to be continued if progress is documented toward functional goals, and if there is no evidence of complications, including misuse or diversion.

    C

    6, 15, 18

    Opioid dosages exceeding 100 mg of morphine or its equivalent may extend the risk of overdose, and should prompt consideration of tapering or referral to a twinge subspecialist.

    C

    13, 27

    Understanding inveterate Pain

    Chronic twinge is different from acute pain, and must be approached differently. Acute twinge is a symptom that plays a functional role in corpse defenses and resolves with tissue recovery. It is transmitted along intact neural pathways that are effectively modulated by opioids to dwindle twinge perception.

    In contrast, inveterate twinge has no such functional role, does not resolve with tissue recovery, and can become a primary diagnosis. inveterate twinge involves involved central nervous system signaling that can be amplified by stressors such as relationship issues, pecuniary problems, or underlying psychiatric diagnoses. This can result in the perception of worse pain, and an increased likelihood of compromised gregarious functioning.10,16,17 Thus, inveterate nonterminal twinge is a biopsychosocial condition that requires a comprehensive, multidisciplinary approach to evaluation and management. Continuing typical treatments for acute pain—including opioid therapy—can be ineffective or unsafe in patients with inveterate pain.

    General Approach to the Patient with inveterate Nonterminal Pain

    Effective management of inveterate nonterminal twinge requires more than prescribing medication.13,15,18 Any potential focal or treatable twinge generators should be identified and treated first. Attention should then circle to physical and psychological modalities, prescription of nonopioid and adjuvant analgesic medications, multimodal treatment of mood disorders, and restoration of sleep.18,19  Only after these measures are optimized should a ordeal of opioid therapy, or continuation of existing opioid therapy, be considered. A comprehensive approach is outlined in Table 1.13,15,18,20

      Enlarge      Print

    Table 1. Treatment of inveterate Pain

    Identify and deal specific local twinge generators, if present

    Cutaneous stimulators (e.g., transcutaneous electrical nerve stimulation)

    Local treatment (e.g., physical therapy, manipulation, massage, heat)

    Minor interventions (e.g., anesthetic or steroid joint injection)

    Surgery

    Topical anesthetics (e.g., lidocaine ointment or patches)

    Promote sound behaviors

    Physical activity

    Weight control

    Restore sleep

    Depending on coexisting problems, useful agents may involve trazodone, tricyclic antidepressants, gabapentin (Neurontin), pregabalin (Lyrica), mirtazapine (Remeron), melatonin, or quetiapine (Seroquel); exhaust of benzodiazepines or their analogs should be avoided because of tolerance and ill-treat potential

    Start adjuvant twinge medications (listed in order of recommended treatments)

    Tricyclic antidepressants are indicated for neuropathic pain; nortriptyline (Pamelor), desipramine (Norpramin), amitriptyline, and doxepin are likewise useful for localized or generalized twinge with coexisting headache, depression, panic disorder, or tobacco addiction

    Serotonin-norepinephrine reuptake inhibitors are indicated for neuropathic pain; duloxetine (Cymbalta) and milnacipran (Savella) are most efficacious for localized or generalized twinge with depression or anxiety, venlafaxine (Effexor) less so; doses for treatment of twinge watch to be higher than those for depression

    Pregabalin is approved by the U.S. Food and Drug Administration for neuropathic twinge and fibromyalgia; gabapentin has similar effectiveness, is available generically, and is more widely used, but it is sedating, and dosing is complex; may be synergistic when combined with tricyclic antidepressants

    Anticonvulsants; carbamazepine (Tegretol) is a first-line agent for trigeminal neuralgia, but third-line (with oxcarbazepine [Trileptal] and lamotrigine [Lamictal]) for other neuropathic pain

    Migraine chemoprophylaxis (e.g., beta blockers, calcium channel blockers, tricyclic antidepressants, topiramate [Topamax])

    Treat comorbid psychiatric illness

    Use of pharmacologic and psychotherapeutic measures is essential for improvement of symptoms and function

    Commonly associated disorders involve anxiety, depression, posttraumatic stress disorder in persons who believe experienced physical, sexual, or emotional trauma; treatment should involve psychotherapy, biofeedback, mindfulness training, posttraumatic stress disorder therapy, relationship counseling, gregarious and pecuniary counseling, and purport ill-treat counseling

    Trial of opioid therapy (initiation or continuation)

    Patients should believe no contraindications for opioid therapy

    Patients with diffuse, centralized twinge or headache are less likely to capitalize from opioid therapy and may be harmed by opioid toxicities

    Select patients with specific somatic, peripheral, or neuropathic twinge may capitalize from low-dose opioid therapy in combination with other treatments

    Treatment should produce demonstrable functional improvement, not merely a reduction in twinge scores, or opioids should be tapered or discontinued

    Table 1. Treatment of inveterate Pain

    Identify and deal specific local twinge generators, if present

    Cutaneous stimulators (e.g., transcutaneous electrical nerve stimulation)

    Local treatment (e.g., physical therapy, manipulation, massage, heat)

    Minor interventions (e.g., anesthetic or steroid joint injection)

    Surgery

    Topical anesthetics (e.g., lidocaine ointment or patches)

    Promote sound behaviors

    Physical activity

    Weight control

    Restore sleep

    Depending on coexisting problems, useful agents may involve trazodone, tricyclic antidepressants, gabapentin (Neurontin), pregabalin (Lyrica), mirtazapine (Remeron), melatonin, or quetiapine (Seroquel); exhaust of benzodiazepines or their analogs should be avoided because of tolerance and ill-treat potential

    Start adjuvant twinge medications (listed in order of recommended treatments)

    Tricyclic antidepressants are indicated for neuropathic pain; nortriptyline (Pamelor), desipramine (Norpramin), amitriptyline, and doxepin are likewise useful for localized or generalized twinge with coexisting headache, depression, panic disorder, or tobacco addiction

    Serotonin-norepinephrine reuptake inhibitors are indicated for neuropathic pain; duloxetine (Cymbalta) and milnacipran (Savella) are most efficacious for localized or generalized twinge with depression or anxiety, venlafaxine (Effexor) less so; doses for treatment of twinge watch to be higher than those for depression

    Pregabalin is approved by the U.S. Food and Drug Administration for neuropathic twinge and fibromyalgia; gabapentin has similar effectiveness, is available generically, and is more widely used, but it is sedating, and dosing is complex; may be synergistic when combined with tricyclic antidepressants

    Anticonvulsants; carbamazepine (Tegretol) is a first-line agent for trigeminal neuralgia, but third-line (with oxcarbazepine [Trileptal] and lamotrigine [Lamictal]) for other neuropathic pain

    Migraine chemoprophylaxis (e.g., beta blockers, calcium channel blockers, tricyclic antidepressants, topiramate [Topamax])

    Treat comorbid psychiatric illness

    Use of pharmacologic and psychotherapeutic measures is essential for improvement of symptoms and function

    Commonly associated disorders involve anxiety, depression, posttraumatic stress disorder in persons who believe experienced physical, sexual, or emotional trauma; treatment should involve psychotherapy, biofeedback, mindfulness training, posttraumatic stress disorder therapy, relationship counseling, gregarious and pecuniary counseling, and purport ill-treat counseling

    Trial of opioid therapy (initiation or continuation)

    Patients should believe no contraindications for opioid therapy

    Patients with diffuse, centralized twinge or headache are less likely to capitalize from opioid therapy and may be harmed by opioid toxicities

    Select patients with specific somatic, peripheral, or neuropathic twinge may capitalize from low-dose opioid therapy in combination with other treatments

    Treatment should produce demonstrable functional improvement, not merely a reduction in twinge scores, or opioids should be tapered or discontinued

    Opioid exhaust and Precautions INITIAL PATIENT SELECTION

    Safe and efficacious opioid therapy requires mindful patient selection. In general, inveterate somatic or neuropathic twinge (e.g., musculoskeletal pain, peripheral neuropathy, postherpetic neuralgia) is at least partially responsive to opioids. However, inveterate visceral or central twinge syndromes (e.g., abdominal or pelvic pain, fibromyalgia, headaches) are less responsive or nonresponsive.11,17,21,22 Patients with these conditions may believe more adverse effects than benefits from inveterate opioid therapy.

    The patient's risk of opioid misuse or ill-treat must be assessed. Several validated tools are available, including the Opioid Risk implement (Table 2).23 Risks should be acknowledged openly and managed, whenever possible, before prescribing opioids. Although no specific cutoffs believe been established, patients with scores of 8 or more on the Opioid Risk implement should be prescribed opioids only after entire other treatment modalities believe been exhausted, under near supervision, and ideally in consultation with a twinge or addiction subspecialist. Opioids should not be prescribed to patients who are actively using illicit substances, as detected during assessment or on pretreatment urine testing.

      Enlarge      Print

    Table 2. Opioid Risk Tool Item Score (females) Score (males)

    Family history of purport abuse

    Alcohol

    1

    3

    Illicit drugs

    2

    3

    Prescription drugs

    4

    4

    Personal history of purport abuse

    Alcohol

    3

    3

    Illicit drugs

    4

    4

    Prescription drugs

    5

    5

    Age 16 to 45 years

    1

    1

    History of preadolescent sexual abuse

    3

    0

    Psychological condition

    ADHD, obsessive-compulsive disorder, bipolar disorder, schizophrenia

    2

    2

    Depression

    1

    1

    Total score

    ––––

    ––––

    Table 2. Opioid Risk Tool Item Score (females) Score (males)

    Family history of purport abuse

    Alcohol

    1

    3

    Illicit drugs

    2

    3

    Prescription drugs

    4

    4

    Personal history of purport abuse

    Alcohol

    3

    3

    Illicit drugs

    4

    4

    Prescription drugs

    5

    5

    Age 16 to 45 years

    1

    1

    History of preadolescent sexual abuse

    3

    0

    Psychological condition

    ADHD, obsessive-compulsive disorder, bipolar disorder, schizophrenia

    2

    2

    Depression

    1

    1

    Total score

    ––––

    ––––

    After mindful screening, opioid therapy may be initiated on a ordeal basis. Guidance for entire phases of opioid prescribing—decision, initiation, maintenance, and tapering—is given in Table 3.13,15,18,19,24 These steps should be followed in entire patients as piece of a universal precautions approach. Controlled medications should not be prescribed on a first visit because of pressure from the patient or a sense of duty to treat.

      Enlarge      Print

    Table 3. Phases of Opioid Prescribing

    Decision phase

    Ensure that patient understands that goal of therapy is improved function, not twinge scores

    Screen for indications (prior successful extend in function, localizable twinge generator)

    Screen for precautions and contraindications in entire patients

    Evidence of multisourcing of controlled medications (check condition prescription monitoring service)

    Medical comorbidities that extend risk (e.g., heart failure, inveterate lung disease, sleep apnea)

    Personal history of alcohol, illicit drug, or prescription drug abuse; exhaust CAGE Questionnaire, Opioid Risk implement (Table 2), and urine drug testing with enzyme-linked immunoassay and gas chromatography/mass spectrometry (interpretation requires imposing care)

    Red-flag behaviors (e.g., lost or stolen prescriptions, requests for early refills, abusive behaviors)

    Urine drug testing using enzyme-linked immunoassay for illicit drugs and gas chromatography/mass spectroscopy for prescribed medications; interpretation requires imposing care

    Uncontrolled psychiatric comorbidities (e.g., anxiety, depression, posttraumatic stress disorder, psychosis)

    Initiation

    Consider sustained-release preparations for more consistent drug levels; patient demands for short-acting medication should be questioned; fentanyl (Duragesic) patches and oxycodone (Roxicodone) believe high potential for ill-treat or diversion; methadone is potentially high risk, but easily monitored; sublingual or transdermal buprenorphine is effective, carries lower risk, and has less ill-treat potential

    Consolidate any other opioid therapy into one medication using an equianalgesic calculator (e.g., http://www.narculator.com); total dosages exceeding a morphine equivalent of 100 mg per day should prompt extra caution and consideration of referral to a twinge management subspecialist

    Stabilize patient with one opioid; avoid polypharmacy with multiple opioids or cotreatment with benzodiazepines (may extend risk of overdose)

    Use a controlled purport agreement; patients generally accomplish not object, but doing so is a potential red flag

    Avoid continuous exhaust of short-acting opioids for breakthrough therapy, or confine their exhaust to the initiation angle of therapy

    Maintenance phase

    Check condition prescription monitoring program before any prescription refills are issued

    Document the exact doses, pill counts, expected duration of the prescription, and circumstances under which refills are to be obtained

    Reassess goals for maintenance or improvement of function, not merely analgesia; taper therapy if functional goals are not achieved

    Repeat urine drug testing with enzyme-linked immunoassay and gas chromatography/mass spectrometry at least yearly (more often if the patient has addiction or diversion risk, or has concerning behaviors)

    Schedule face-to-face visits at least every three months (more frequently during titration or if misuse is suspected)

    Write prescriptions that witness the exact dates they can be filled

    When to stop, taper, or hunt consultation

    Stop prescribing immediately if patient tests positive for illicit drug exhaust or displays threatening behavior, or in the event of forgery or intoxication

    Taper if functional goals are not achieved, adverse effects are excessive, or medication is misused

    Consider referral if functional goals are not achieved, or for multidisciplinary twinge or addiction treatment

    Table 3. Phases of Opioid Prescribing

    Decision phase

    Ensure that patient understands that goal of therapy is improved function, not twinge scores

    Screen for indications (prior successful extend in function, localizable twinge generator)

    Screen for precautions and contraindications in entire patients

    Evidence of multisourcing of controlled medications (check condition prescription monitoring service)

    Medical comorbidities that extend risk (e.g., heart failure, inveterate lung disease, sleep apnea)

    Personal history of alcohol, illicit drug, or prescription drug abuse; exhaust CAGE Questionnaire, Opioid Risk implement (Table 2), and urine drug testing with enzyme-linked immunoassay and gas chromatography/mass spectrometry (interpretation requires imposing care)

    Red-flag behaviors (e.g., lost or stolen prescriptions, requests for early refills, abusive behaviors)

    Urine drug testing using enzyme-linked immunoassay for illicit drugs and gas chromatography/mass spectroscopy for prescribed medications; interpretation requires imposing care

    Uncontrolled psychiatric comorbidities (e.g., anxiety, depression, posttraumatic stress disorder, psychosis)

    Initiation

    Consider sustained-release preparations for more consistent drug levels; patient demands for short-acting medication should be questioned; fentanyl (Duragesic) patches and oxycodone (Roxicodone) believe high potential for ill-treat or diversion; methadone is potentially high risk, but easily monitored; sublingual or transdermal buprenorphine is effective, carries lower risk, and has less ill-treat potential

    Consolidate any other opioid therapy into one medication using an equianalgesic calculator (e.g., http://www.narculator.com); total dosages exceeding a morphine equivalent of 100 mg per day should prompt extra caution and consideration of referral to a twinge management subspecialist

    Stabilize patient with one opioid; avoid polypharmacy with multiple opioids or cotreatment with benzodiazepines (may extend risk of overdose)

    Use a controlled purport agreement; patients generally accomplish not object, but doing so is a potential red flag

    Avoid continuous exhaust of short-acting opioids for breakthrough therapy, or confine their exhaust to the initiation angle of therapy

    Maintenance phase

    Check condition prescription monitoring program before any prescription refills are issued

    Document the exact doses, pill counts, expected duration of the prescription, and circumstances under which refills are to be obtained

    Reassess goals for maintenance or improvement of function, not merely analgesia; taper therapy if functional goals are not achieved

    Repeat urine drug testing with enzyme-linked immunoassay and gas chromatography/mass spectrometry at least yearly (more often if the patient has addiction or diversion risk, or has concerning behaviors)

    Schedule face-to-face visits at least every three months (more frequently during titration or if misuse is suspected)

    Write prescriptions that witness the exact dates they can be filled

    When to stop, taper, or hunt consultation

    Stop prescribing immediately if patient tests positive for illicit drug exhaust or displays threatening behavior, or in the event of forgery or intoxication

    Taper if functional goals are not achieved, adverse effects are excessive, or medication is misused

    Consider referral if functional goals are not achieved, or for multidisciplinary twinge or addiction treatment

    If an initial evaluation raises questions about whether opioid therapy is appropriate, the physician should openly avow these concerns with the patient and entrust to deal the twinge comprehensively through other means. If opioids are not arrogate in a patient who is already taking them, therapy should not be continued because of concerns about withdrawal. Although it is uncomfortable, opioid withdrawal is generally not life-threatening, and the patient can be referred to an addiction subspecialist for management.

    VISIT CHECKLISTS

    Visit checklists can be used to evaluate whether initiation or continuation of opioid therapy is appropriate. Items should involve evidence or absence of progress toward twinge relief and functional goals, evidence of red-flag behaviors (e.g., lost prescriptions, frequent early requests for refills), and the presence of uncontrolled psychiatric illness or medical comorbidities. Such checklists, if used routinely, may be especially useful in group practices where multiple physicians may reliance for the selfsame patients.

    URINE TESTING

    All patients should undergo urine drug testing before opioid therapy is initiated, and then at least yearly unless patient deportment suggests the need for more frequent testing. An enzyme-linked immunoassay for drugs of ill-treat (e.g., amphetamine, marijuana, cocaine) and gas chromatography/mass spectrometry to detect prescribed agents should be ordered. The opioid portion of most enzyme-linked immunoassays reliably detects only morphine or codeine, and misses hydrocodone, oxycodone, hydromorphone (Dilaudid), oxymorphone, fentanyl (Duragesic), methadone, and buprenorphine. These drugs are detected by gas chromatography/ mass spectrometry, especially if the laboratory is asked to check for these or other specific drugs in patients known to be prescribed one or more of them. Both tests may produce false-positive or false-negative results, so reliance must be taken to avoid misinterpretation of patient adherence. Concise guides to test interpretation are available.13,15,25

    PRESCRIPTION MONITORING

    Many states believe established prescription monitoring programs (http://www.painpolicy.wisc.edu/domestic/pmp.htm). Online access is available in most states and can identify a patient's controlled prescriptions for the preceding year by drug name, strength, quantity, date of prescription, date prescription was filled, prescriber, and pharmacy used. Office staff can routinely obtain this information before visits by patients receiving opioid therapy.

    WRITTEN AGREEMENTS

    Many sample twinge and controlled medication agreements are available (e.g., http://www.aapainmanage.org/literature/Articles/OpioidAgreements.pdf). These agreements outline arrogate intervals for follow-up, refill policies, participation in any indicated multimodal management objective (e.g., physical therapy, psychological treatment), exhaust of only one prescriber and one pharmacy for entire controlled medications, and prohibition of illicit purport exhaust or prescription diversion. As with urine testing and prescription monitoring program reporting, written agreements should be piece of an ongoing treatment objective for entire patients receiving inveterate opioid therapy, thereby avoiding reliance on physician judgment, suspicion, or bias.

    Selecting an Initial Opioid

    Morphine should be the first option for inveterate potent opioid therapy. Reliable, inexpensive, long-acting oral morphine preparations are available for patients receiving inveterate therapy. If the patient must later be switched to another medication, morphine doses are the units on which opioid equianalgesic calculations are based. Common adverse effects involve constipation, nausea, pruritus, and drowsiness, entire of which are more common than morphine allergy. Morphine should be used with caution (especially its long-acting preparations) in patients with renal failure.

    Oxycodone is an alternative for patients with morphine intolerance or allergy. However, it may believe a higher risk of ill-treat and should be used with caution in patients with higher risk scores. Long-acting oxycodone is not recommended for patients with inveterate twinge because it is not truly long-acting, is expensive, and has a high street value. Transdermal fentanyl may be a better alternative, although it is expensive and can produce tolerance relatively quickly. Fentanyl is lipophilic, and absorption is affected in patients with dinky subcutaneous stout and in those recumbent to edema at application sites.

    Methadone can be efficacious for many patients and may produce less tolerance than other opioids. It is inexpensive, long-acting, and has a combination of opioid and N-methyl-d-aspartate receptor activity that may design it a friendly option for patients with mixed somatic and neuropathic pain. However, physicians who prescribe methadone must be familiar with its unique pharmacokinetics: it has a very long elimination half-life, and its morphine-equivalent equianalgesic conversion ratio increases as dosages increase. Starting dosages in opioid-naive patients are 2.5 to 5 mg two or three times per day. Dosages should be titrated slowly and no more than once per week. Methadone can prolong the QT interval, especially in patients who are taking other QT-prolonging medications. Serum drug levels can be used for monitoring. Methadone does not interfere with urine testing for other opioids.

    Buprenorphine is a partial opioid agonist that is less likely to produce tolerance.26 It is efficacious for treatment of pain, has lower ill-treat potential, and is easily monitored. However, it is expensive, and its exhaust requires special prescriber training (except for the transdermal patch).

    Breakthrough Dosing

    Short-acting opioids (e.g., morphine, oxycodone, hydromorphone) may be used during initiation of long-acting opioids, but should not be used continuously as primary or breakthrough treatment. Breakthrough dosing has not been shown to improve outcomes and can extend the risk of overdose, misuse, and further opioid tolerance.24 Because of the high street value of many short-acting opioids, requests for breakthrough doses should be resisted; if they are prescribed, only little quantities should be given (e.g., 10 doses per month).

    Multiple Opioids and High-Dose Therapy

    The exhaust of multiple opioids should be avoided whenever possible; equianalgesic conversions can be used to consolidate therapies (a implement is available at http://www.narculator.com). Total opioid doses exceeding 100 mg of morphine or its equivalent are associated with an increased risk of overdose and should prompt consideration of tapering or referral to a twinge subspecialist.13,27 The need for such referral should be framed as an issue of medication safety and effectiveness, not suspicion or judgment of patients or their behavior.

    Tapering or Discontinuing Therapy

    Opioid therapy should be reassessed for safety and effectiveness in entire patients at least quarterly. Issues of patient safety or illegal activity should prompt discontinuation (Table 4).

      Enlarge      Print

    Table 4. Indications for Tapering or Discontinuing Opioids

    Immediate discontinuation

    Belligerent or threatening deportment toward physician or staff

    Confirmation of diversion, multisourcing, or prescription forgery

    Confirmation of illicit drug use, including marijuana

    Overdose

    Rapid tapering

    Frequent requests for early refills, despite adequate titration of long-acting opioids

    Major adverse effects or intoxication (e.g., somnolence, slurred speech, altered sensorium)

    Opioid-induced hyperalgesia

    Other nonadherence to twinge medication agreement

    Gradual tapering

    Functional goals not met

    Morphine equivalent dosage greater than 100 mg per day, without pellucid capitalize to function or pain

    Persistent adverse effects despite opioid rotation (e.g., pruritus, nausea, refractory constipation)

    Table 4. Indications for Tapering or Discontinuing Opioids

    Immediate discontinuation

    Belligerent or threatening deportment toward physician or staff

    Confirmation of diversion, multisourcing, or prescription forgery

    Confirmation of illicit drug use, including marijuana

    Overdose

    Rapid tapering

    Frequent requests for early refills, despite adequate titration of long-acting opioids

    Major adverse effects or intoxication (e.g., somnolence, slurred speech, altered sensorium)

    Opioid-induced hyperalgesia

    Other nonadherence to twinge medication agreement

    Gradual tapering

    Functional goals not met

    Morphine equivalent dosage greater than 100 mg per day, without pellucid capitalize to function or pain

    Persistent adverse effects despite opioid rotation (e.g., pruritus, nausea, refractory constipation)

    Before tapering, entire opioid therapy should be consolidated into a solitary long-acting medication using equianalgesic calculations. Dose reduction should then proceed at a rate that avoids opioid withdrawal symptoms, loss of patient confidence, or twinge escalation,28 and should continue until symptoms or function is improved. Gradual tapering can be accomplished by reducing the original total opioid dose by 10 percent every one to four weeks until 20 percent of the original total dose remains, then reducing by 5 percent of the original dose until it is discontinued. Rapid tapering can be accomplished by reducing the original dose by 25 percent every three to seven days; this will avoid austere withdrawal symptoms.

    Despite tapering, some patients may believe withdrawal symptoms when opioids are completely discontinued. These symptoms should be managed supportively; traditional withdrawal management medications such as clonidine (Catapres), tramadol (Ultram), and muscle relaxants are generally ineffective, although temporary exhaust of nonbenzodiazepine sleep aids can be helpful. Follow-up visits should be scheduled frequently for ongoing multimodal twinge management and encouragement that function will improve over weeks to months.

    Data Sources: Searches of the human, English literature were conducted in Medline, Cochrane reports, and the National Guideline Clearinghouse for clinical trials and guidelines published from January 1, 2000, through April 25, 2011, using the major keywords of inveterate pain, non-malignant, non-cancer, and non-terminal. Terms used for specific topic searches included twinge assessment, psychiatric comorbidities, addiction risk, opioid abuse, emergency department visits, twinge mechanisms, opioid-induced hyperalgesia, opioid tolerance, opioid taper, long-term outcomes, and buprenorphine. Search date: January 2011 through April 2011.


    Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis | killexams.com actual questions and Pass4sure dumps

    Patients Table 1. Table 1. Demographic and Disease Characteristics of the Patients at Baseline (Intention-to-Treat Population).

    Overall, 1656 patients underwent randomization (intention-to-treat population), with 821 patients in the OPERA I ordeal and 835 in the OPERA II trial. The demographic and disease characteristics at baseline were similar in the assigned groups in the two trials (Table 1). In the OPERA I trial, 366 of 410 patients (89.3%) in the ocrelizumab group and 340 of 411 (82.7%) in the interferon beta-1a group completed the 96-week treatment; in the OPERA II trial, 360 of 417 patients (86.3%) and 320 of 418 (76.6%), respectively, completed the 96-week treatment (Fig. S2 in the Supplementary Appendix). There was no interaction between treatment group and trial, which allowed the pooling of data for the prespecified planned hierarchical analysis (Table S9 in the Supplementary Appendix). In the pooled analysis, which included 827 patients treated with ocrelizumab and 829 treated with interferon beta-1a, entire the primary and secondary conclude points significantly favored the ocrelizumab group over the interferon beta-1a group.

    Efficacy Relapses Table 2. Table 2. Clinical and MRI conclude Points during the 96-Week Trials.

    Clinical, MRI, and patient-reported outcomes are summarized in Table 2. The primary conclude point, the annualized relapse rate at 96 weeks, in the OPERA I ordeal was 0.16 in the ocrelizumab group, as compared with 0.29 in the interferon beta-1a group (difference, 0.14 annualized relapses [differences are based on unrounded data]). In the OPERA II trial, the annualized relapse rate was 0.16 in the ocrelizumab group, as compared with 0.29 in the interferon beta-1a group (difference, 0.14 annualized relapses) (Table 2). These findings witness a 46% lower annualized relapse rate with ocrelizumab in the OPERA I ordeal and a 47% lower rate with ocrelizumab in the OPERA II ordeal (P<0.001 for both comparisons).

    Disability Figure 1. Figure 1. Key Secondary Clinical conclude Points.

    Shown are the proportions of patients with disability progression confirmed at 12 weeks (first secondary conclude point; Panel A) and at 24 weeks (fifth secondary conclude point; Panel B) in time-to-event analyses in the pooled ordeal populations. Disability progression that was confirmed at 12 or 24 weeks was defined as an extend from the baseline Expanded Disability Status Scale (EDSS) score (on a scale from 0 to 10.0, with higher scores indicating worse disability) of at least 1.0 point (or 0.5 points if the baseline EDSS score was >5.5) that was sustained for at least 12 or 24 weeks. The numbers shown on the curves represent Kaplan–Meier estimates of the risk of the event at week 96. The insets expose the selfsame data on an expanded y axis.

    In the prespecified pooled analysis, the percentage of patients with disability progression confirmed at 12 weeks was 9.1% in the ocrelizumab group, as compared with 13.6% in the interferon beta-1a group (40% lower risk with ocrelizumab; hazard ratio, 0.60; 95% confidence interval [CI], 0.45 to 0.81; P<0.001) (Figure 1A). Over the 96-week ordeal period, the rate of disability progression confirmed at 24 weeks was 6.9% in the ocrelizumab group, as compared with 10.5% in the interferon beta-1a group (40% lower risk with ocrelizumab; hazard ratio, 0.60; 95% CI, 0.43 to 0.84; P=0.003) (Figure 1B). The sequel of ocrelizumab on the risk of confirmed disability progression in each of the two trials was consistent with the prespecified pooled analysis (Table 2).

    In a pooled analysis, the percentage of patients with disability improvement confirmed at 12 weeks was 20.7% in the ocrelizumab group, as compared with 15.6% in the interferon beta-1a group (33% higher rate of improvement with ocrelizumab, P=0.02) (Fig. S5 in the Supplementary Appendix). The sequel of ocrelizumab on the rate of confirmed disability improvement was significant in the OPERA I ordeal but nonsignificant in the OPERA II ordeal (Table 2).

    The contrast in the adjusted import change in the Multiple Sclerosis Functional Composite score from baseline to week 96 between the ocrelizumab group and the interferon beta-1a group was 0.04 in the OPERA I ordeal (P=0.33, which was the first nonsignificant P value in the hierarchical testing) and 0.11 in the OPERA II ordeal (P=0.004) (Table 2, and Fig. S6 in the Supplementary Appendix). As a result of the failure in the statistical hierarchical testing, entire the P values for the subsequent secondary efficacy conclude points, including the change in the SF-36 quality-of-life physical-component summary and the measure of no evidence of disease activity, were considered to be nonconfirmatory.

    In the intention-to-treat population in the OPERA I trial, 47.9% of the patients in the ocrelizumab group had no evidence of disease activity by 96 weeks (exploratory conclude point), as compared with 29.2% of those in the interferon beta-1a group. In the OPERA II trial, 47.5% of the patients in the ocrelizumab group had no evidence of disease activity by 96 weeks, as compared with 25.1% of those in the interferon beta-1a group. These findings were considered to be nonconfirmatory as a result of failure of the hierarchical analysis (Table 2, and Table S6 in the Supplementary Appendix).

    MRI-Related Secondary conclude Points Figure 2. Figure 2. MRI conclude Point.

    Shown are the import numbers of gadolinium-enhancing lesions per T1-weighted MRI scan by week 96 (second secondary conclude point). The number of lesions was divided by the total number of MRI scans of the brain by week 96. In the OPERA I trial, the number of lesions on the MRI scan at 96 weeks was 94% lower in the ocrelizumab group than in the interferon beta-1a group; in the OPERA II trial, the number of lesions was 95% lower in the ocrelizumab group than in the interferon beta-1a group. Adjusted P values are shown.

    The total import number of gadolinium-enhancing lesions per T1-weighted MRI scan in the OPERA I ordeal was 0.02 with ocrelizumab versus 0.29 with interferon beta-1a (94% lower number of lesions with ocrelizumab, P<0.001). The values in the OPERA II ordeal were 0.02 with ocrelizumab versus 0.42 with interferon beta-1a (95% lower number of lesions with ocrelizumab, P<0.001) (Table 2 and design 2, and Fig. S7 in the Supplementary Appendix).

    The total import numbers of new or newly enlarged hyperintense lesions per T2-weighted MRI scan in the OPERA I ordeal was 0.32 with ocrelizumab versus 1.41 with interferon beta-1a (77% lower number of lesions with ocrelizumab, P<0.001). The values in the OPERA II ordeal were 0.33 with ocrelizumab versus 1.90 with interferon beta-1a (83% lower number of lesions with ocrelizumab, P<0.001) (Table 2, and Figs. S8 and S13 in the Supplementary Appendix). Most of the new or newly enlarged lesion activity on T2-weighted MRI in the ocrelizumab groups occurred between baseline and week 24 (Fig. S8 in the Supplementary Appendix). From week 24 to week 48, the number of lesions was 94% lower in the ocrelizumab group than in the interferon beta-1a group in the OPERA I ordeal and 96% lower in the ocrelizumab group than in the interferon beta-1a group in the OPERA II trial. From week 48 to week 96 the number of lesions was 98% lower and 97% lower in the ocrelizumab group than in the interferon beta-1a group in the OPERA I ordeal and the OPERA II trial, respectively.

    The total import number of new hypointense lesions on T1-weighted MRI in the OPERA I ordeal was 0.42 with ocrelizumab versus 0.98 with interferon beta-1a (57% lower number of lesions with ocrelizumab, P<0.001). The values in the OPERA II ordeal were 0.45 with ocrelizumab versus 1.26 with interferon beta-1a (64% lower number of lesions with ocrelizumab, P<0.001) (Table 2, and Fig. S9 in the Supplementary Appendix). As a result of the failure in the statistical hierarchical testing, the differences in the percentage of brain-volume loss from week 24 to week 96 between the ocrelizumab group and the interferon beta-1a group were nonconfirmatory in the OPERA I ordeal (nominal P=0.004) and nonsignificant in the OPERA II ordeal (nominal P=0.09) (Table 2, and Fig. S10 in the Supplementary Appendix).

    Safety Adverse Events Table 3. Table 3. Adverse Events (Safety Population).

    A total of 327 of 408 patients (80.1%) in the ocrelizumab group reported an adverse event in the OPERA I trial, as compared with 331 of 409 (80.9%) in the interferon beta-1a group; the corresponding values in the OPERA II ordeal were 360 of 417 patients (86.3%) and 357 of 417 (85.6%) (Table 3). The most common adverse events were infusion-related reaction, nasopharyngitis, upper respiratory tract infection, headache, and urinary tract infection in patients treated with ocrelizumab and influenza-like illness, injection-site erythema, headache, urinary tract infection, and upper respiratory tract infection in patients treated with interferon beta-1a.

    Serious adverse events were reported in 6.9% of the patients treated with ocrelizumab and in 7.8% of those treated with interferon beta-1a in the OPERA I ordeal and in 7.0% of the patients treated with ocrelizumab and in 9.6% of those treated with interferon beta-1a in the OPERA II ordeal (Table 3). Three deaths occurred, including one death in the ocrelizumab group (suicide in the OPERA II trial) and two in the interferon beta-1a group (one suicide in the OPERA I trial, and one death due to mechanical ileus in the OPERA II trial).

    Infections

    Infection was reported in 232 patients (56.9%) in the ocrelizumab group and in 222 (54.3%) in the interferon beta-1a group in the OPERA I trial; the corresponding values in the OPERA II ordeal were 251 (60.2%) and 219 (52.5%) (Table 3). The most common infections (reported in ≥10% of the patients in either group across both trials) were upper respiratory tract infection, nasopharyngitis, and urinary tract infection. There were more reports in the ocrelizumab group than in the interferon beta-1a group of upper respiratory tract infection (15.2% vs. 10.5%) and nasopharyngitis (14.8% vs. 10.2%), whereas urinary tract infection was more frequent in the interferon beta-1a group (11.6% vs. 12.1%). The overall percentage of patients reporting a grave infection was 1.3% in the ocrelizumab group and 2.9% in the interferon beta-1a group (Table S5 in the Supplementary Appendix). The selfsame pattern was seen when they used a broader definition of grave infection, including nonserious infection treated with an intravenous antiinfective treatment (1.8% in the ocrelizumab group vs. 3.8% in the interferon beta-1a group). No opportunistic infections were reported in any group over the duration of either trial.

    Across the two trials, the percentage of patients reporting herpesvirus-associated infection was 5.9% in the ocrelizumab group and 3.4% in the interferon beta-1a group (Tables S3 and S4 in the Supplementary Appendix). entire these events were mild or qualify (Common Terminology Criteria for Adverse Events grade 1 or 2, as defined in Supplementary Appendix), with one exception: in the OPERA I trial, a patient treated with ocrelizumab for 1.6 years was hospitalized for a austere genital herpes simplex infection, which resolved with treatment.

    Infusion-Related Reactions

    More patients in the ocrelizumab group (34.3%) than in the interferon beta-1a group (9.7%) had at least one infusion-related reaction. Patients in the interferon beta-1a group received placebo infusions. In the OPERA I trial, at least one infusion-related reaction occurred in 30.9% of the patients in the ocrelizumab group and in 7.3% of those in the interferon beta-1a group; the corresponding values in the OPERA II ordeal were 37.6% and 12.0%. Most infusion-related reactions were mild to moderate, were reported at the first infusion of dose 1 (Fig. S11 in the Supplementary Appendix), and were managed with infusion adjustments and treatment of symptoms. One patient in the ocrelizumab group in the OPERA I ordeal had a life-threatening episode of bronchospasm during the first infusion of dose 1; the patient declined hospitalization, recovered with treatment, and was withdrawn from the ordeal according to the protocol. The most frequent symptoms of infusion-related reaction with ocrelizumab included pruritus, rash, throat irritation, and flushing.

    Laboratory Assessments

    CD19+ cells represent a measure of B-cell counts in anti-CD20–treated patients. The smooth of CD19+ cells decreased to negligible levels with ocrelizumab treatment by week 2. (See the Additional Methodology Details section and Fig. S12 in the Supplementary Appendix.)

    Antidrug-binding antibodies developed in 3 of 825 patients (0.4%) who received ocrelizumab across the two trials, with neutralizing antibodies developing in 1 patient in the OPERA II trial. Across the two trials, neutralizing anti–interferon beta-1a antibodies were detected in 21.3% of the patients.

    Neoplasms

    Across these two 96-week trials, four neoplasms (in 0.5% of patients) occurred in the ocrelizumab group (two cases of invasive ductal breast carcinoma, one case of renal-cell carcinoma, and one case of malignant melanoma), and two occurred (in 0.2%) in the interferon beta-1a group (one case of mantle-cell lymphoma and one case of squamous-cell carcinoma in the chest) (Table 3). Between the clinical cutoff dates of the two trials (April 2, 2015, in the OPERA I ordeal and May 12, 2015, in the OPERA II trial) and June 30, 2016, five additional cases of neoplasm (two cases of breast cancer, two cases of basal-cell skin carcinoma, and one case of malignant melanoma) were detected during the open-label extension study, during which entire the patients received ocrelizumab. As of June 30, 2016, the overall incidence rate of first neoplasm among patients treated with ocrelizumab across entire studies involving patients with multiple sclerosis was 0.40 per 100 patient-years of exposure to ocrelizumab (6467 patient-years of exposure), as compared with 0.20 per 100 patient-years of exposure in the pooled comparator groups (2053 patient-years of exposure in groups receiving interferon beta-1a or placebo). (See Table S6 in the Supplementary Appendix for the ORATORIO trial, the results of which are now published in the Journal.24)



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    By William Nickels, James McHugh, Susan McHugh
    Publisher : McGraw-Hill (May 2018)
    ISBN10 : 1260682137
    ISBN13 : 9781260682137
    Our ISBN10 : 126009233X
    Our ISBN13 : 9781260092332
    Subject : Business & Economics
    Price : $80.00
    Understanding BusinessUnderstanding Business
    By William Nickels, James McHugh, Susan McHugh
    Publisher : McGraw-Hill (Jan 2018)
    ISBN10 : 1260277143
    ISBN13 : 9781260277142
    Our ISBN10 : 126009233X
    Our ISBN13 : 9781260092332
    Subject : Business & Economics
    Price : $77.00
    Understanding BusinessUnderstanding Business
    By William Nickels, James McHugh, Susan McHugh
    Publisher : McGraw-Hill (Jan 2018)
    ISBN10 : 1259929434
    ISBN13 : 9781259929434
    Our ISBN10 : 126009233X
    Our ISBN13 : 9781260092332
    Subject : Business & Economics
    Price : $76.00
    250-510250-510
    By Peter W. Cardon
    Publisher : McGraw-Hill (Jan 2017)
    ISBN10 : 1260128474
    ISBN13 : 9781260128475
    Our ISBN10 : 1259921883
    Our ISBN13 : 9781259921889
    Subject : Business & Economics, Communication & Media
    Price : $39.00
    250-510250-510
    By Peter Cardon
    Publisher : McGraw-Hill (Feb 2017)
    ISBN10 : 1260147150
    ISBN13 : 9781260147155
    Our ISBN10 : 1259921883
    Our ISBN13 : 9781259921889
    Subject : Business & Economics, Communication & Media
    Price : $64.00
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