Nathania Elma Fithriyah, Khafiyah Hikmah Rahmadhani, Luthfiana Rofhani Susanti, Arifa Mustika, Lita Diah Rahmawati, Citrawati Dyah Kencono Wungu

Efficacy of Ozoralizumab vs. Golimumab for Rheumatoid Arthritis: A Systematic Review

Introduction

Efficacy of ozoralizumab vs. Golimumab for rheumatoid arthritis: a systematic review. Compare the efficacy of ozoralizumab vs. golimumab for rheumatoid arthritis in this systematic review. Discover potential advantages of ozoralizumab, a novel TNF-α inhibitor, for RA patients.

Abstract

Introduction: Rheumatoid arthritis, a systemic autoimmune disease, affects 13% of the world population. As a well-established therapy, golimumab provides a key benchmark for assessing novel biological treatments. In contrast, ozoralizumab represents an innovative therapeutic approach. This study aimed to comprehensively elucidate the efficacy of golimumab and ozoralizumab in reducing rheumatoid arthritis disease activity. Methods: Literature searches were conducted throughout PubMed, Cochrane, and Web of Science using Boolean operators, covering available records from database inception until October 2024. The literature search was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The included studies were randomized controlled trials (RCT) evaluating the efficacy of ozoralizumab or golimumab for rheumatoid arthritis. Five studies from 2015 to 2022 were obtained and assessed using the Cochrane Risk of Bias 2 (ROB2) tool. Results: The five studies consisted of two ozoralizumab trials and three golimumab trials conducted in Japan and the United States, involving 2,305 participants. All included studies exhibited a low risk of bias based on assessments undertaken using the ROB2 tool. The differences in Disease Activity Score-28 (DAS28) remission rates between ozoralizumab and placebo were 42.6% in one study and 6.3% in the other, whereas golimumab mainly showed smaller differences versus placebo across three studies (4.6%, 5.9%, and 10.4%). Conclusion: This study demonstrates DAS28 remission in rheumatoid arthritis patients receiving either ozoralizumab or golimumab therapy. Nonetheless, further direct statistical studies are essential to determine which therapy is superior and under what circumstances it should be administered. Highlights: 1. This study provides robust evidence that establishes ozoralizumab as a novel tumor necrosis factor-alpha (TNF-α) inhibitor for rheumatoid arthritis. 2. According to the findings, ozoralizumab may be a clinician's choice due to its comparable efficacy and potential advantages over golimumab.

Review

This systematic review set out to compare the efficacy of ozoralizumab and golimumab in the context of rheumatoid arthritis, an important clinical question given the emergence of novel biologics. The methodology appears robust, adhering to PRISMA guidelines for literature searching across major databases (PubMed, Cochrane, Web of Science) up to October 2024, and utilizing the Cochrane ROB2 tool for bias assessment of included randomized controlled trials. While the scope of including RCTs for *either* drug separately is clear, the title "Efficacy of Ozoralizumab vs. Golimumab" suggests a direct comparative analysis which, as detailed in the results, was not feasible given the nature of the included studies. The review identified five studies – two on ozoralizumab and three on golimumab – all deemed to have a low risk of bias. The reported findings highlight the individual efficacy of each drug against placebo, primarily in terms of DAS28 remission rates. For ozoralizumab, the remission rates varied considerably (42.6% in one study versus 6.3% in another), while golimumab showed more consistent, albeit generally lower, differences versus placebo (4.6% to 10.4%). While both drugs demonstrate the ability to induce DAS28 remission, the disparate and non-comparative nature of the presented data precludes any definitive conclusions about the relative superiority of one over the other based on these results alone. The bold claim in the highlights that ozoralizumab "may be a clinician's choice due to its comparable efficacy" is not directly supported by the presented remission rates, which are not statistically compared, and the highly variable ozoralizumab efficacy results. In conclusion, this systematic review effectively synthesizes available evidence for the individual efficacy of ozoralizumab and golimumab in rheumatoid arthritis. Its primary strength lies in its systematic approach and rigorous risk of bias assessment. However, a significant limitation is its inability to provide a direct head-to-head comparison between the two agents, which the title implicitly promises. The authors correctly identify the critical need for further direct statistical studies to definitively determine which therapy is superior and under what specific clinical circumstances. Future research should prioritize such comparative trials to guide clinical decision-making, and could also explore the reasons behind the substantial heterogeneity observed in ozoralizumab's reported efficacy.

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