Table 2.
Head-to-Head Trials with Biologic and Synthetic DMARDs in Rheumatoid Arthritis
| Study | Design | Drugs | Follow Up | Number of Patients | Primary End Point | Results |
|---|---|---|---|---|---|---|
| EXXELERATE | RCT superiority | CMZ + MTX vs ETN + MTX | 104 weeks | 915 | ACR 20 week 12 LDA week 104 |
CMZ + MTX is not superior to ETN + MTX |
| AMPLE | RCT non inferiority | SC ABA + MTX vs ADA + MTX | 2 years | 645 | ACR 20 at 1 year | SC ABA + MTX is not inferior to ADA + MTX |
| ADACTA | RCT superiority | TCZ IV vs ADA | 24 weeks | 326 | Change DAS 28 at 24 weeks | TCZ monotherapy is superior to ADA monotherapy |
| MONARCH | RCT superiority | SARI vs ADA | 24 weeks | 369 | Change DAS 28 ERS at 24 weeks | SARI monotherapy is superior to ADA monotherapy |
| ENTRACTE | RCT non inferiority | TCZ IV vs ETN | 3.2 years | 3080 | Time of occurrence of first MACE | TCZ was not inferior to ETN |
| ORAL STRATEGY | RCT non inferiority | TOFA monotherapy TOFA + MTX ADA + MTX |
1 year | 1146 | ACR 50 at 6 months | TOFA + MTX was non inferior to ADA + MTX |
| RA BEAN | RCT non inferiority superiority | PBO + MTX BARI + MTX ADA + MTX |
52 weeks | 1307 | ACR 20 at 24 weeks | BARI + MTX non inferior to ADA+ MTX BARI + MTX superior to ADA + MTX |
| SELECT COMPARE | RCT superiority | PBO + MTX UPA + MTX ADA + MTX |
48 weeks | 1629 | ACR 20 and DAS28 CPR <2.6 at week 12 | UPA + MTX superior to ADA + MTX in terms of ACR 50, DAS28 CPR≤3.2 |
| SELECT CHOICE | RCT superiority | UPA + csDMARDs ABA IV + csDMARDs |
24 weeks | 612 | Change DAS 28 CPR at week 12 | UPA was superior to ABA |
| FINCH 1 | RCT non inferiority | FILGO 100 + MTX FILGO 200 + MTX ADA + MTX PBO + MTX |
52 weeks | 1755 | ACR 20 week 12 | FILGO 200 non inferior to ADA based on DAS28 CPR≤3.2 |
| NCT02092467 | RCT non inferiority | TOFA 5 mg bid TOFA 10 mg bid ADA/ETN |
5 years | 4369 | MALIGNANCY MACE |
Pending results |
| RA BRANCH | RCT non inferiority | BARI 2 mg BARI 4 mg ADA/ETN |
5.5 years | 1300 | VTE | Pending results |
Abbreviations: RTC, randomised controlled trial; CZM, certolizumab pegol; ETN, etanercept; MTX, methotrexate; SC, subcutaneous; IV, intravenous; ABA, abatacept; ADA, adalimumab; TCZ, tocilizumab; SARI, sarilumab; TOFA, tofacitinib; BARI, baricitinib; UPA, upadacitinib; csDMARDs, conventional synthetic disease modifying antirheumatic drugs; FILGO, filgotinib; ACR, American College Rheumatology response; DAS 28 CPR, disease activity score 28 c reactive protein; LDA, low disease activity; MACE, major adverse cardiovascular events; VTE, venous thromboembolism event.