Nipocalimab and certolizumab combination therapy in participants with active rheumatoid arthritis despite prior treatment with advanced therapies: results from the phase 2a DAISY-RA study

Taylor PC, Schett G, Huizinga TW, Ibrahim F, Zhou B, Huang S, Gambale J, Wang Q, Liva SG, Leu JH, Hubbard JJ, Leonardo S, Panchakshari RA, Loza MJ, Fei K (2026)

Publication Type: Journal article

Publication year: 2026

Journal

RMD Open BMJ Publishing Group

Book Volume: 12

Article Number: e006464

Journal Issue: 1

DOI: 10.1136/rmdopen-2025-006464

Abstract

Objectives: To investigate the efficacy, safety, pharmacokinetics, immunogenicity and pharmacodynamics of combination therapy with nipocalimab and certolizumab in participants with active rheumatoid arthritis (RA) despite treatment with advanced therapies. Methods: In this phase 2a study, participants were randomised 3:2 to receive combination therapy with nipocalimab (intravenous 30 mg/kg) and certolizumab (subcutaneous 400 mg at weeks 0, 2, 4, then 200 mg) or certolizumab monotherapy every 2 weeks from weeks 0 to 24. The primary endpoint was change from baseline in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) at week 12. Other outcomes were assessed through week 30. Results: 103 participants were enrolled (combination therapy/monotherapy, n=62/41). At week 12, the primary endpoint was similar between groups (least squares mean 90% CI –1.92 (–2.48 to –1.36) vs –1.86 (–2.44 to –1.28); p=0.822). Secondary endpoints were also similar between groups, although numerically higher proportions of participants treated with combination therapy versus monotherapy achieved ≥50% response in American College of Rheumatology criteria (ACR50), DAS28-CRP <2.6 and DAS28-CRP ≤3.2 at week 12. Serious adverse events were reported in 11.3% of participants in the combination therapy group and 2.4% in the monotherapy group. In combination with certolizumab, nipocalimab exhibited nonlinear pharmacokinetics with accelerated clearance and substantially, reversibly reduced serum immunoglobulin G, including anticitrullinated protein antibody levels. Conclusions: Combination therapy of nipocalimab with certolizumab showed a similar outcome in the primary endpoint and secondary endpoints compared with certolizumab monotherapy in participants with active RA.

Authors with CRIS profile

Georg Schett Lehrstuhl für Innere Medizin III

Involved external institutions

Johnson & Johnson US United States (USA) (US) Johnson & Johnson Services, Inc. US United States (USA) (US) University of Oxford GB United Kingdom (GB) Leiden University Medical Center NL Netherlands (NL)

How to cite

APA:

Taylor, P.C., Schett, G., Huizinga, T.W., Ibrahim, F., Zhou, B., Huang, S.,... Fei, K. (2026). Nipocalimab and certolizumab combination therapy in participants with active rheumatoid arthritis despite prior treatment with advanced therapies: results from the phase 2a DAISY-RA study. RMD Open, 12(1). https://doi.org/10.1136/rmdopen-2025-006464

MLA:

Taylor, Peter C., et al. "Nipocalimab and certolizumab combination therapy in participants with active rheumatoid arthritis despite prior treatment with advanced therapies: results from the phase 2a DAISY-RA study." RMD Open 12.1 (2026).

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