PMID- 36791623
OWN - NLM
STAT- MEDLINE
DCOM- 20230404
LR  - 20230404
IS  - 2211-0356 (Electronic)
IS  - 2211-0348 (Linking)
VI  - 71
DP  - 2023 Mar
TI  - Comparative efficacy and safety of ozanimod and ponesimod for relapsing multiple 
      sclerosis: A matching-adjusted indirect comparison.
PG  - 104551
LID - S2211-0348(23)00055-X [pii]
LID - 10.1016/j.msard.2023.104551 [doi]
AB  - BACKGROUND: Ozanimod and ponesimod are sphingosine 1-phosphate receptor 
      modulators approved by the U.S. Food and Drug Administration for treatment of 
      relapsing forms of multiple sclerosis (MS). Given that no head-to-head trials 
      have assessed these two treatments, we performed a matching-adjusted indirect 
      comparison (MAIC) to compare efficacy and safety outcomes between ozanimod and 
      ponesimod for MS. METHODS: A MAIC compared efficacy and safety of ozanimod and 
      ponesimod at 2 years. Outcomes included annualized relapse rate (ARR) and 
      percentage change from baseline in brain volume loss (BVL) as well as rates of 
      any treatment-emergent adverse events (TEAEs), serious adverse events (AEs), AEs 
      leading to discontinuation, and other safety outcomes. Individual patient-level 
      data were obtained for ozanimod from the RADIANCE-B trial, while aggregate-level 
      patient data were obtained for ponesimod from the OPTIMUM trial. The MAIC was not 
      anchored owing to lack of a common comparator across the two trials. The 
      following characteristics were matched between the trials' populations: age, sex, 
      time since MS symptom onset, relapses in prior year, Expanded Disability Status 
      Scale score, disease-modifying therapies received in the prior 2 years, absence 
      of gadolinium-enhancing T1 lesions, and percentage of patients from Eastern 
      Europe. RESULTS: After matching, key baseline characteristics were balanced 
      between patients receiving ozanimod and ponesimod. Compared with ponesimod, 
      ozanimod had a numerically lower ARR (rate ratio: 0.80 [95% CI: 0.57, 1.10]) and 
      was associated with a significant reduction in BVL (% change difference: 0.20 
      [95% CI: 0.05, 0.36]). Additionally, ozanimod was associated with a significantly 
      lower risk of TEAEs (risk difference: -11.9% [95% CI: -16.8%, -7.0%]), AEs 
      leading to discontinuation (-6.1% [95% CI: -8.9%, -3.4%]), and lymphocyte count 
      <0.2 K/muL (-2.3% [95% CI: -4.2%, -0.5%]). There were no statistically significant 
      differences in the other safety outcomes. CONCLUSION: The MAIC results suggest 
      that, compared with ponesimod, ozanimod is more effective in preserving brain 
      volume, is comparable in terms of reducing relapse rates, and has a favorable 
      safety profile.
CI  - Copyright (c) 2023. Published by Elsevier B.V.
FAU - Swallow, Elyse
AU  - Swallow E
AD  - Analysis Group, Inc., 111 Huntington Ave., 14th floor, Boston, MA 02199, United 
      States of America. Electronic address: elyse.swallow@analysisgroup.com.
FAU - Pham, Timothy
AU  - Pham T
AD  - Bristol Myers Squibb, 3401 Princeton Pike, Lawrence Township, NJ 08648, United 
      States of America.
FAU - Patterson-Lomba, Oscar
AU  - Patterson-Lomba O
AD  - Analysis Group, Inc., 111 Huntington Ave., 14th floor, Boston, MA 02199, United 
      States of America.
FAU - Yin, Lei
AU  - Yin L
AD  - Analysis Group, Inc., 333 S. Hope St., #27, Los Angeles, CA 90071, United States 
      of America.
FAU - Gomez-Lievano, Andres
AU  - Gomez-Lievano A
AD  - Analysis Group, Inc., 111 Huntington Ave., 14th floor, Boston, MA 02199, United 
      States of America.
FAU - Liu, Jingyi
AU  - Liu J
AD  - Analysis Group, Inc., 111 Huntington Ave., 14th floor, Boston, MA 02199, United 
      States of America.
FAU - Tencer, Tom
AU  - Tencer T
AD  - Bristol Myers Squibb, 3401 Princeton Pike, Lawrence Township, NJ 08648, United 
      States of America.
FAU - Gupte-Singh, Komal
AU  - Gupte-Singh K
AD  - Bristol Myers Squibb, 3401 Princeton Pike, Lawrence Township, NJ 08648, United 
      States of America.
LA  - eng
PT  - Journal Article
DEP - 20230206
PL  - Netherlands
TA  - Mult Scler Relat Disord
JT  - Multiple sclerosis and related disorders
JID - 101580247
RN  - Z80293URPV (ozanimod)
RN  - 5G7AKV2MKP (ponesimod)
SB  - IM
MH  - Humans
MH  - *Multiple Sclerosis/drug therapy
MH  - *Multiple Sclerosis, Relapsing-Remitting/drug therapy/pathology
MH  - Recurrence
OTO - NOTNLM
OT  - Matching-adjusted indirect comparison
OT  - Ozanimod
OT  - Ponesimod
OT  - Relapsing multiple sclerosis
COIS- Declaration of Competing Interest Elyse Swallow, Oscar Patterson-Lomba, Lei Yin, 
      Andres Gomez-Lievano, and Jingyi Liu are employees of Analysis Group, which 
      received funding from Bristol Myers Squibb for the conduct of this study. Timothy 
      Pham and Tom Tencer were employees of Bristol Myers Squibb at the time of this 
      study and may be shareholders of the company. Komal Gupte-Singh is an employee of 
      Bristol Myers Squibb and may be a shareholder of the company.
EDAT- 2023/02/16 06:00
MHDA- 2023/04/04 06:42
CRDT- 2023/02/15 18:14
PHST- 2022/09/23 00:00 [received]
PHST- 2023/01/10 00:00 [revised]
PHST- 2023/02/03 00:00 [accepted]
PHST- 2023/04/04 06:42 [medline]
PHST- 2023/02/16 06:00 [pubmed]
PHST- 2023/02/15 18:14 [entrez]
AID - S2211-0348(23)00055-X [pii]
AID - 10.1016/j.msard.2023.104551 [doi]
PST - ppublish
SO  - Mult Scler Relat Disord. 2023 Mar;71:104551. doi: 10.1016/j.msard.2023.104551. 
      Epub 2023 Feb 6.