DECIDE pivotal clinical trial: outcome up to 144 weeks1
45% relative reduction
DECIDE was a randomized, double-blind, active control study that compared ZINBRY TA 150 mg subcutaneous (n=919) every 4 weeks to AVONEX 30 mcg intramuscular (n=922)
weekly. Treatment continued for 96 to 144 weeks. The primary outcome measure was the annualized relapse rate (ARR). Additional outcome measures included the proportion
of patients relapsed, the proportion of patients who experienced confirmed disability progression (CDP), and the number of new or newly enlarging T2 hyperintense lesions.
The study included RMS patients with an Expanded Disability Status Scale (EDSS) score of 0.0-5.0 who had either: 1) ≥ 2 relapses during the prior 3 years and ≥ 1 relapse in the year
prior to randomization; or 2) ≥ 1 clinical relapses and ≥ 1 new T1 gadolinium (Gd)-enhancing or T2 hyperintense MRI lesions within the prior 2 years with at least one of these events
in the prior 12 months. Patients with progressive forms of MS were excluded.
SELECT pivotal clinical trial: outcome at 52 weeks1
54% relative reduction
Annualized relapse rate
Annualized relapse rate
SELEC T was a randomized, double-blind, placebo-controlled study that compared ZINBRY TA 150 mg subcutaneous (n=208) every 4 weeks to placebo (n=204). Treatment duration
was 52 weeks. The primary outcome measure was ARR at Week 52. Additional outcome measures included new T1 Gd-enhancing lesions between Weeks 8 to 24, the proportion
of patients relapsed, the proportion of patients who experienced 12-week CDP, and the number of new or newly enlarging T2 hyperintense lesions. The study included RMS patients
with an EDSS score of 0.0-5.0 who had experienced ≥ 1 relapse in the year prior to randomization or who had ≥ 1 T1 Gd-enhancing MRI lesions within 6 weeks of randomization. Patients
with progressive forms of MS were excluded.
Important Safety Information (Continued)
Immune-Mediated Disorders (Continued)
regarding emergent immune-mediated disorders. For suspected immune-mediated
disorders, ensure adequate evaluation to confirm etiology or to exclude other causes.
If a patient develops a serious immune disorder, consider stopping ZINBRY TA and refer
the patient to an appropriate specialist for further evaluation and treatment.
1 ZINBRY TA causes skin reactions. In clinical trials, skin reactions occurred in 37% of
ZINBRY TA-treated patients compared with 19% of AVONEX-treated patients
(Study 1) and in 18% of ZINBRY TA-treated patients compared with 13% of patients
on placebo (Study 2). Skin reactions occurred at any time during treatment
with ZINBRY TA. If a patient develops a serious diffuse or inflammatory rash, it is
recommended that a dermatologist evaluate the patient before the next dose of
ZINBRY TA. Discontinuation of ZINBRY TA may be appropriate
1 ZINBRY TA increases the incidence of lymphadenopathy. In controlled studies,
lymphadenopathy or lymphadenitis occurred in 6% of ZINBRY TA-treated patients
compared with 1% of AVONEX-treated patients (Study 1) and in 2% of ZINBRY TA-treated patients compared with 1% of placebo-treated patients (Study 2)
1 An increased incidence of serious colitis (less than 1%) was reported in patients
treated with ZINBR Y TA compared with none for patients treated with AVONEX or
placebo in clinical trials
1 A wide variety of other immune-mediated disorders, some serious, have occurred
infrequently with the use of ZINBRY TA. If a patient develops a serious immune
disorder, consider stopping ZINBRY TA
ZINBRY TA REMS Program
ZINBRY TA is available only through a restricted program called the ZINBRY TA REMS
Program, because of the risks of hepatic injury including autoimmune hepatitis, and
other immune-mediated disorders. Only certified prescribers and pharmacies and
patients enrolled in the REMS program can prescribe, dispense or receive ZINBRY TA.
ZINBRY TA can cause anaphylaxis, angioedema, and urticaria after the first dose or at
any time during treatment. Discontinue and do not re-start ZINBRY TA if anaphylaxis or
other allergic reactions occur.
ZINBRY TA increases the risk for infections. The most common types of infections
observed were upper respiratory tract infections, urinary tract infections and viral
infections. Avoid initiating ZINBRY TA in patients with severe active infection until
the infection is fully controlled. If serious infection develops, consider withholding
treatment with ZINBRY TA until the infection resolves.
1 Vaccination with live vaccines is not recommended during treatment and up to
4 months after discontinuation of ZINBR Y TA
Depression and Suicide
In controlled trials, depression-related events occurred in 10% of ZINBR Y TA-treated
patients compared with 8% of AVONEX-treated patients (Study 1) and in 7% of
ZINBRY TA-treated patients compared with 2% of patients taking placebo (Study 2).
Administer ZINBRY TA with caution to patients with previous or current depressive
disorders. Advise patients and/or caregivers to immediately report any symptoms of
new or worsening depression and/or suicidal ideation. If a patient develops severe
depression and/or suicidal ideation, consider discontinuation of ZINBRY TA.
The most common adverse reactions (incidence at least 5% and at least 2%
higher incidence than comparator) that occurred in ZINBRY TA-treated patients
were nasopharyngitis, upper respiratory tract infection, rash, influenza, dermatitis,
oropharyngeal pain, bronchitis, eczema, and lymphadenopathy compared with
AVONEX; and upper respiratory tract infection, depression, rash, pharyngitis, and
increased ALT compared with placebo.
© 2017 Biogen and AbbVie Inc. All rights reserved. 01/17. ZIN-US-0768
Reference: 1. ZINBRY TA Prescribing Information. Biogen, Cambridge, MA, AbbVie Inc., North Chicago, IL. 2016.
Please see the following pages for additional Important Safety Information and
Brief Summary of Full Prescribing Information, including BOXED WARNING.