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

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