Peginterferon Beta-1a Demonstrated Better Clinical Outcomes Than Teriflunomide in Newly Diagnosed Relapsing Multiple Sclerosis (RMS) Patients: A Matching-Adjusted Comparison of Phase 3 Trial Data (P1.360)

Objective: Determine the indirect comparative clinical efficacy of peginterferon beta-1a and teriflunomide in RMS patients and a subgroup of newly diagnosed, disease-modifying therapy (DMT)–naive RMS patients. Background: Peginterferon beta-1a and teriflunomide are both first-line DMTs for RMS, but no head-to-head trials have directly compared their clinical efficacy. A matching-adjusted comparison can provide relevant comparative efficacy data to clinicians. Design/Methods: Individual patient data from studies of subcutaneous peginterferon beta-1a 125 mcg every 2 weeks (ADVANCE/ATTAIN) and pooled summary data of patients from studies of oral teriflunomide 14 mg once daily (TEMSO, TOWER) were used. TEMSO and TOWER study designs and patient populations were sufficiently similar to allow data pooling. A matching-adjusted comparison of efficacy outcomes was conducted by weighting individual peginterferon beta-1a–treated patients to match key aggregate baseline characteristics of teriflunomidetreated patients. “Newly diagnosed” patients had been diagnosed with RMS ≤1 year prior to study enrollment and had no prior DMT use. Results: After matching, baseline characteristics were well-balanced across groups. In the overall population at 108 weeks, peginterferon beta-1a (effective n=382) had a significantly lower proportion of patients than teriflunomide (n=728) with 24-week confirmed disability worsening (CDW) (8.4% vs 12.6%; P =0.032), and the annualized relapse rate (ARR) was numerically lower with peginterferon beta-1a than with teriflunomide (0.257 vs 0.354; P =0.051). Similarly, in newly diagnosed RMS patients, the ARR was numerically lower in patients treated with peginterferon beta-1a (effective n=163) than with teriflunomide (n=183) at 108 weeks (0.201 vs 0.270; P =0.384) and 5 years (0.142 vs 0.196; P value not analyzed). Conclusions: In this matching-adjusted indirect comparison of phase 3 trials, the proportion of patients with 24-week CDW was significantly lower with peginterferon beta-1a than with teriflunomide. For both the overall population and the newly diagnosed subgroup, ARR was numerically lower with peginterferon beta-1a than with teriflunomide. Study Supported by: Biogen Disclosure: Dr. Newsome has nothing to disclose. Dr. Yun has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Castrillo-Viguera has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen. Dr. Castrillo-Viguera holds stock and/or stock options in Holds stock/stock options in Biogen. Dr. Naylor has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Biogen.