Table 1.

Summary of Clinical Studies on Dual Biologic Therapy Indicated for Treatment of Rheumatoid Arthritis.

Author (Year), Country, ref. Study Design Dual Therapy (n Patients) Control Arm (n Patients, if applicable) Study Duration (mo) Primary Study Outcome Efficacy of Dual Biologic TX (Yes/No) Safety Outcomes of Dual Biologic TX
Genovese (2004), USA7 RCT Half-dosage ETN+ANA (n=81);Full-dosage ETN+ANA (n=81) ETN (n=80) 6 Efficacy: ACR50 at 6 mo No Increased rate of SAEs
Weinblatt (2006), USA8 RCT ABA+TNFi or ABA+ANA (n=103) TNFi or ANA (n=64) 12 Safety Post-hoc analysis: No Increased rate of SAEs
Weinblatt (2007), USA9 RCT ABA+ETN (n=85) ETN (n=36) 12 Efficacy: ACR20 at 6 mo No Increased rate of SAEs
Blank (2009), Germany10 Retr. RTX+ETN (n=6) RTX (n=12) 8 Safety Yes Similar safety
Greenwald (2011), USA11 RCT RTX (2×500 mg)+TNFi+MTX (n=33) TNFi+MTX (n=18) 6 Safety No Similar safety
Rigby (2013), USA12 Open-label study RTX (2×500 mg)+TNFi or ABA±DMARDs (n=176) None 12 Safety N.a. Similar safety
Genovese (2018), Inter-national24 Phase II RCT ABT-122 (n=166) ADA (n=55) 3 Safety and efficacy: ACR20 at week 12 Similar efficacy Similar safety
Glatt (2019), UK25 Phase IIa RCT CTZ+BKZ (n=52) CTZ (n=27) 5 Efficacy: DAS28 (CRP) at week 20 and safety Yes Increased rate of adverse events

ABA, abatacept; ABT-122, a dual variable domain immune-globulin targeting human TNF and IL-17A; ACR, American College of Rheumatology; ADA, adalimumab; ANA, anakinra; BKZ, bimekizumab; CRP, C-reactive protein; CTZ, certolizumab; DAS, disease activity score; DMARDs, disease-modifying antirheumatic drugs; ETN, etanercept; IL-17, interleukin 17; mo, months; MTX, methotrexate; N.a., not applicable; RCT, randomized controlled trial; Retr., retrospective; RTX, rituximab; SAEs, serious adverse events; TNFi, tumor necrosis factor inhibitor; TX, treatment; UK, United Kingdom; USA, United States of America.

RMMJ Rambam Maimonides Medical Journal Rambam Health Care Campus 2023 April; 14(2): e0007. ISSN: 2076-9172
Published online 2023 April 30. doi: 10.5041/RMMJ.10494