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