PMID- 33979770
OWN - NLM
STAT- MEDLINE
DCOM- 20210706
LR  - 20210706
IS  - 2211-0356 (Electronic)
IS  - 2211-0348 (Linking)
VI  - 52
DP  - 2021 Jul
TI  - Matching-adjusted indirect treatment comparison of ozanimod versus teriflunomide 
      for relapsing multiple sclerosis.
PG  - 102972
LID - S2211-0348(21)00239-X [pii]
LID - 10.1016/j.msard.2021.102972 [doi]
AB  - BACKGROUND: A growing number of immunomodulating disease-modifying therapies are 
      available for treatment of relapsing multiple sclerosis (RMS). In the absence of 
      randomized head-to-head trials, matching-adjusted indirect comparisons (MAICs) 
      can be used to adjust for cross-trial differences and evaluate the comparative 
      efficacy and safety of these agents. We used MAIC methodology to indirectly 
      compare key outcomes with ozanimod (OZM) and teriflunomide (TERI) in the 
      treatment of RMS. METHODS: A systematic literature review was conducted to 
      identify clinical trials evaluating the efficacy and safety of OZM vs TERI. Given 
      the absence of head-to-head trials of OZM vs TERI, we used a matching-adjusted 
      indirect comparison to adjust for potential treatment effect modifiers and 
      prognostic factors while assessing confirmed disability progression (CDP), 
      relapse, and safety outcomes. Individual patient data for OZM (SUNBEAM and 
      RADIANCE Part B trials) and aggregate level data for TERI (ASCLEPIOS I/II, TOWER, 
      OPTIMUM, and TEMSO trials) were used to evaluate the following outcomes: 
      annualized relapse rate (ARR), proportion of patients relapsed, CDP at 3 and 6 
      months, overall adverse events (AEs), serious AEs (SAEs), and discontinuations 
      due to AEs. RESULTS: After matching, baseline patient characteristics were 
      balanced between OZM and TERI. Compared with TERI, OZM demonstrated significant 
      improvements in ARR (rate ratio: 0.73; 95% CI: 0.62-0.84), proportion of patients 
      relapsed (odds ratio [OR]: 0.56; 95% CI: 0.44-0.70), overall AEs (OR: 0.35; 95% 
      CI: 0.29-0.43), SAEs (OR: 0.53; 95% CI: 0.37-0.77), and discontinuations due to 
      AEs (OR: 0.14; 95% CI: 0.09-0.21). OZM demonstrated statistically significant 
      improvements in CDP at 3 months (hazard ratio [HR]: 0.78; 95% CI: 0.66-0.92) but 
      nonsignificant differences at 6 months (HR: 0.78; 95% CI: 0.60-1.01) compared 
      with TERI. CONCLUSION: In this indirect treatment comparison of patients with 
      RMS, OZM appeared to have an improved benefit-risk profile over TERI.
CI  - Copyright (c) 2021 The Author(s). Published by Elsevier B.V. All rights reserved.
FAU - Cohan, Stanley
AU  - Cohan S
AD  - Providence Multiple Sclerosis Center, Providence Brain and Spine Institute, 2805 
      NE Glisan St., Portland, OR, 97213 USA. Electronic address: 
      Stanley.Cohan@providence.org.
FAU - Tencer, Tom
AU  - Tencer T
AD  - Bristol Myers Squibb, 3551 Lawrenceville Rd., Princeton, NJ, 08540 USA.
FAU - Arndorfer, Stella
AU  - Arndorfer S
AD  - Genesis Research, 5 Marine View Plaza, Hoboken, NJ, 07030 USA.
FAU - Zhu, Xuelian
AU  - Zhu X
AD  - Genesis Research, 5 Marine View Plaza, Hoboken, NJ, 07030 USA.
FAU - Zivkovic, Marko
AU  - Zivkovic M
AD  - Genesis Research, 5 Marine View Plaza, Hoboken, NJ, 07030 USA.
FAU - Kumar, Jinender
AU  - Kumar J
AD  - Bristol Myers Squibb, 3551 Lawrenceville Rd., Princeton, NJ, 08540 USA.
LA  - eng
PT  - Journal Article
PT  - Systematic Review
DEP - 20210425
PL  - Netherlands
TA  - Mult Scler Relat Disord
JT  - Multiple sclerosis and related disorders
JID - 101580247
RN  - 0 (Crotonates)
RN  - 0 (Hydroxybutyrates)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Indans)
RN  - 0 (Nitriles)
RN  - 0 (Oxadiazoles)
RN  - 0 (Toluidines)
RN  - 1C058IKG3B (teriflunomide)
RN  - Z80293URPV (ozanimod)
SB  - IM
MH  - Crotonates
MH  - Humans
MH  - Hydroxybutyrates
MH  - Immunosuppressive Agents
MH  - Indans
MH  - *Multiple Sclerosis
MH  - *Multiple Sclerosis, Relapsing-Remitting
MH  - Nitriles
MH  - Oxadiazoles
MH  - Recurrence
MH  - Toluidines
OTO - NOTNLM
OT  - Annualized relapse rate
OT  - Confirmed disability progression
OT  - Disease-modifying therapy
OT  - Individual patient data
OT  - Safety
EDAT- 2021/05/13 06:00
MHDA- 2021/07/07 06:00
CRDT- 2021/05/12 20:14
PHST- 2020/12/22 00:00 [received]
PHST- 2021/03/15 00:00 [revised]
PHST- 2021/04/16 00:00 [accepted]
PHST- 2021/05/13 06:00 [pubmed]
PHST- 2021/07/07 06:00 [medline]
PHST- 2021/05/12 20:14 [entrez]
AID - S2211-0348(21)00239-X [pii]
AID - 10.1016/j.msard.2021.102972 [doi]
PST - ppublish
SO  - Mult Scler Relat Disord. 2021 Jul;52:102972. doi: 10.1016/j.msard.2021.102972. 
      Epub 2021 Apr 25.