Trials investigating Janus kinase inhibitors and tumour necrosis factor alpha inhibitors
Study | Population | Risk of bias | Treatment | n | Primary end point | P value | % of patients achieving primary end point |
---|---|---|---|---|---|---|---|
Rheumatoid arthritis | |||||||
van Vollenhoven 2012 (ORAL Standard)30 | MTX-IR | Low | PLC+MTX (Combination group) | 106 | % ACR20 (week 24) | Reference | 28 |
TOFA 5 mg two times per day+MTX | 204 | <0.001 | 52 | ||||
TOFA 10 mg two times per day+MTX | 201 | <0.001 | 53 | ||||
ADA 40 mg EOW+MTX | 204 | <0.001 | 47 | ||||
Fleischmann 2017 (ORAL Strategy)31 | MTX-IR | Low | TOFA 5 mg two times per day+PLC | 384 | Non-inferiority: % ACR50 (week 24) | NI not met −8% (98.34% CI −16 to 1) | 65 |
TOFA 5 mg two times per day+MTX | 376 | NI met 2% (98.34% CI −6 to 11) | 73 | ||||
ADA 40 mg Q2W+MTX | 386 | Reference | 71 | ||||
Taylor 2017 (RA-BEAM)32 | MTX-IR | Low | PLC+MTX | 488 | Superiority: % ACR20 (week 12) | – | 40 |
BARI 4 mg+MTX | 487 | 0.01 | 70 | ||||
ADA 40 mg EOW+MTX | 330 | Reference | 61 | ||||
Fleischmann 2018 (SELECT-COMPARE)33 34 | MTX-IR | Low | PLC+MTX | 651 | Superiority: % ACR50 (week 12) | – | 15 |
UPA 15 mg OD+MTX | 651 | <0.001 | 45 | ||||
ADA 40 mg EOW+MTX | 327 | Reference | 29 | ||||
Psoriatic arthritis | |||||||
Mease 2017 (OPAL Broaden)5 | csDMARD-IR | Low | PLC±csDMARD | 105 | % ACR20 (week 12) ΔHAQ (week 12) | Reference | 33; −0.18 |
TOFA 5 mg two times per day±csDMARD | 107 | <0.01; 0.006 | 50; −0.35 | ||||
TOFA 10 mg two times per day±csDMARD | 104 | <0.001; <0.001 | 61; −0.4 | ||||
ADA 40 mg EOW±csDMARD | 106 | NR | 52; −0.38 | ||||
Chronic plaque psoriasis | |||||||
Bachelez 201535 | Candidates for systemic therapy or phototherapy +PASI >12 +PGA moderate/severe +csDMARD-IR | Low | Placebo | 107 | Non-inferiority: % PASI 75 (week 12) % PGA clear/almost clear (week 12) | – | 6 |
TOFA 5 mg two times per day | 329 | NI not met <0.001/<0.001 | 40 | ||||
TOFA 10 mg two times per day | 330 | NI met 0.20/0.60 | 64 | ||||
ETA 50 mg twice weekly | 335 | Reference | 59 |
ACR, American College of Rheumatology; ADA, adalimumab; BARI, baricitinib; csDMARD, conventional synthetic disease-modifying antirheumatic drug; EOW, every other week; ETA, etanercept; ΔHAQ, changes from baseline in Health Assessment Questionnaire-Disability Index; IR, insufficient responder; MTX, methotrexate; NI, non-inferiority; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PLC, placebo; TOFA, tofacitinib; UPA, upadacitinib.