Matching-adjusted comparisons demonstrate better clinical outcomes with SC peginterferon beta-1a every two weeks than with SC interferon beta-1a three times per week.
Mult Scler Relat Disord
; 22: 134-138, 2018 May.
Article
in En
| MEDLINE
| ID: mdl-29679749
ABSTRACT
BACKGROUND:
Subcutaneous (SC) peginterferon beta-1a and SC interferon beta-1a (IFN beta-1a) have demonstrated efficacy in treating relapsing-remitting multiple sclerosis (RRMS) but have never been compared in direct head-to-head clinical trials, the gold-standard comparison. A well-balanced matching-adjusted comparison of weighted individual patient data on SC peginterferon beta-1a, and aggregate data from published phase 3 clinical trials of SC IFN beta-1a, was conducted to provide additional information on the comparative efficacy of these two agents.METHODS:
Individual patient data from a study of SC peginterferon beta-1a 125â¯mcg every two weeks (ADVANCE) and pooled summary data from four published studies of SC IFN beta-1a 44â¯mcg three times per week (OPERA I and II, CARE-MS I and II) with similar populations were utilized. A comparison was conducted by weighting individual peginterferon beta-1a-treated patients, using estimated propensity of enrolling in SC IFN beta-1a treatment to match multiple key aggregate baseline characteristics of SC IFN beta-1a-treated patients. After matching, weighted annualized relapse rate (ARR), 24-week confirmed disability worsening (CDW), and clinical no evidence of disease activity (clinical-NEDA) were calculated and compared for peginterferon beta-1a and SC IFN beta-1a.RESULTS:
After matching, baseline characteristics were well balanced across treatment groups. At 2 years, ARR after matching was 0.256 for patients receiving peginterferon beta-1a (effective nâ¯=â¯376) and 0.335 for those receiving SC IFN beta-1a (nâ¯=â¯1218) (Pâ¯=â¯0.0901). The percentage of patients who were relapse free over 2 years was significantly higher with peginterferon beta-1a than with SC IFN beta-1a (75.1% vs. 57.4% [after matching], Pâ¯<â¯0.0001). The peginterferon beta-1a treatment group had a significantly lower proportion of patients with 24-week CDW compared with SC IFN beta-1a (after matching 6.5% vs. 13.2%; Pâ¯=â¯0.0007). Clinical-NEDA occurred in a significantly higher proportion of patients treated with SC peginterferon beta-1a versus SC IFN beta-1a (74.1% vs. 48.1%; Pâ¯<â¯0.0001).CONCLUSIONS:
This matching-adjusted comparison using data from four phase 3 trials with SC IFN beta-1a formulations demonstrated that patients with RRMS treated with SC peginterferon beta-1a 125â¯mcg every two weeks achieved better clinical outcomes than patients who received SC IFN beta-1a 44â¯mcg three times per week.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Polyethylene Glycols
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Interferon-beta
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Multiple Sclerosis, Relapsing-Remitting
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Immunologic Factors
Type of study:
Clinical_trials
Limits:
Adult
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Female
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Humans
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Male
Language:
En
Journal:
Mult Scler Relat Disord
Year:
2018
Type:
Article