Comparative efficacy of ofatumumab

annualized relapse rate confirmed disability progression indirect treatment comparison propensity score relapsing multiple sclerosis simulated treatment comparison

Journal

Therapeutic advances in neurological disorders
ISSN: 1756-2856
Titre abrégé: Ther Adv Neurol Disord
Pays: England
ID NLM: 101480242

Informations de publication

Date de publication:
2024
Historique:
received: 21 11 2023
accepted: 14 02 2024
medline: 25 3 2024
pubmed: 25 3 2024
entrez: 25 3 2024
Statut: epublish

Résumé

Evidence from network meta-analyses (NMAs) and real-world propensity score (PS) analyses suggest monoclonal antibodies (mAbs) offer a therapeutic advantage over currently available oral therapies and, therefore, warrant consideration as a distinct group of high-efficacy disease-modifying therapies (DMTs) for patients with relapsing multiple sclerosis (RMS). This is counter to the current perception of these therapies by some stakeholders, including payers. A multifaceted indirect treatment comparison (ITC) approach was undertaken to clarify the relative efficacy of mAbs and oral therapies. Two ITC methods that use individual patient data (IPD) to adjust for between-trial differences, PS analyses and simulated treatment comparisons (STCs), were used to compare the mAb ofatumumab As IPD were available for trials of ofatumumab and fingolimod, PS analyses were conducted. Given summary-level data were available for cladribine, fingolimod, and ozanimod trials, STCs were conducted between ofatumumab and each of these oral therapies. Three efficacy outcomes were compared: annualized relapse rate (ARR), 3-month confirmed disability progression (3mCDP), and 6-month CDP (6mCDP). The PS analyses demonstrated ofatumumab was statistically superior to fingolimod for ARR and time to 3mCDP but not time to 6mCDP. In STCs, ofatumumab was statistically superior in reducing ARR and decreasing the proportion of patients with 3mCDP compared with cladribine, fingolimod, and ozanimod and in decreasing the proportion with 6mCP compared with fingolimod and ozanimod. These findings were largely consistent with recently published NMAs that identified mAb therapies as the most efficacious DMTs for RMS. Complementary ITC methods showed ofatumumab was superior to cladribine, fingolimod, and ozanimod in lowering relapse rates and delaying disability progression among patients with RMS. Our study supports the therapeutic superiority of mAbs over currently available oral DMTs for RMS and the delineation of mAbs as high-efficacy therapies.

Sections du résumé

Background UNASSIGNED
Evidence from network meta-analyses (NMAs) and real-world propensity score (PS) analyses suggest monoclonal antibodies (mAbs) offer a therapeutic advantage over currently available oral therapies and, therefore, warrant consideration as a distinct group of high-efficacy disease-modifying therapies (DMTs) for patients with relapsing multiple sclerosis (RMS). This is counter to the current perception of these therapies by some stakeholders, including payers.
Objectives UNASSIGNED
A multifaceted indirect treatment comparison (ITC) approach was undertaken to clarify the relative efficacy of mAbs and oral therapies.
Design UNASSIGNED
Two ITC methods that use individual patient data (IPD) to adjust for between-trial differences, PS analyses and simulated treatment comparisons (STCs), were used to compare the mAb ofatumumab
Data sources and methods UNASSIGNED
As IPD were available for trials of ofatumumab and fingolimod, PS analyses were conducted. Given summary-level data were available for cladribine, fingolimod, and ozanimod trials, STCs were conducted between ofatumumab and each of these oral therapies. Three efficacy outcomes were compared: annualized relapse rate (ARR), 3-month confirmed disability progression (3mCDP), and 6-month CDP (6mCDP).
Results UNASSIGNED
The PS analyses demonstrated ofatumumab was statistically superior to fingolimod for ARR and time to 3mCDP but not time to 6mCDP. In STCs, ofatumumab was statistically superior in reducing ARR and decreasing the proportion of patients with 3mCDP compared with cladribine, fingolimod, and ozanimod and in decreasing the proportion with 6mCP compared with fingolimod and ozanimod. These findings were largely consistent with recently published NMAs that identified mAb therapies as the most efficacious DMTs for RMS.
Conclusion UNASSIGNED
Complementary ITC methods showed ofatumumab was superior to cladribine, fingolimod, and ozanimod in lowering relapse rates and delaying disability progression among patients with RMS. Our study supports the therapeutic superiority of mAbs over currently available oral DMTs for RMS and the delineation of mAbs as high-efficacy therapies.

Identifiants

pubmed: 38525490
doi: 10.1177/17562864241239453
pii: 10.1177_17562864241239453
pmc: PMC10960976
doi:

Types de publication

Journal Article

Langues

eng

Pagination

17562864241239453

Informations de copyright

© The Author(s), 2024.

Auteurs

Nicholas Riley (N)

Novartis Pharmaceuticals Australia, Sydney, NSW, Australia.

Christopher Drudge (C)

EVERSANA, Value and Evidence, Burlington, ON, Canada.

Morag Nelson (M)

Novartis Pharmaceuticals Australia, Sydney, NSW, Australia.

Anja Haltner (A)

EVERSANA, Value and Evidence, Chicago, IL, USA.

Michael Barnett (M)

Brain and Mind Centre, University of Sydney, Camperdown, NSW, Australia.
Royal Prince Alfred Hospital, Camperdown, NSW, Australia.

Simon Broadley (S)

School of Medicine, Griffith University, Southport, QLD, Australia.

Helmut Butzkueven (H)

Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia.

Pamela McCombe (P)

UQ Centre for Clinical Research Faculty of Medicine, University of Queensland, St. Lucia, QLD, Australia.

Anneke Van der Walt (A)

Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia.

Erin O Y Wong (EOY)

EVERSANA, Value and Evidence, Burlington, ON, Canada.

Martin Merschhemke (M)

Novartis Pharma AG, Basel, Switzerland.

Nicholas Adlard (N)

Novartis Pharma AG, Basel, Switzerland.

Rob Walker (R)

Novartis Pharmaceuticals Australia, Sydney, NSW, Australia.

Imtiaz A Samjoo (IA)

EVERSANA, Value and Evidence, 113-3228 South Service Road, Burlington, ON, Canada, L7N 3H8.

Classifications MeSH