Table 2

Trials investigating Janus kinase inhibitors and tumour necrosis factor alpha inhibitors

StudyPopulationRisk of biasTreatmentnPrimary end pointP value% of patients achieving primary end point
Rheumatoid arthritis
van Vollenhoven 2012 (ORAL Standard)30 MTX-IRLowPLC+MTX (Combination group)106% ACR20 (week 24)Reference28
TOFA 5 mg two times per day+MTX204<0.00152
TOFA 10 mg two times per day+MTX201<0.00153
ADA 40 mg EOW+MTX204<0.00147
Fleischmann 2017 (ORAL Strategy)31 MTX-IRLowTOFA 5 mg two times per day+PLC384Non-inferiority:
% ACR50 (week 24)
NI not met
−8% (98.34% CI −16 to 1)
65
TOFA 5 mg two times per day+MTX376NI met
2% (98.34% CI −6 to 11)
73
ADA 40 mg Q2W+MTX386Reference71
Taylor 2017 (RA-BEAM)32 MTX-IRLowPLC+MTX488Superiority:
% ACR20 (week 12)
40
BARI 4 mg+MTX4870.0170
ADA 40 mg EOW+MTX330Reference61
Fleischmann 2018 (SELECT-COMPARE)33 34 MTX-IRLowPLC+MTX651Superiority:
% ACR50 (week 12)
15
UPA 15 mg OD+MTX651<0.00145
ADA 40 mg EOW+MTX327Reference29
Psoriatic arthritis
Mease 2017 (OPAL Broaden)5 csDMARD-IRLowPLC±csDMARD105% ACR20 (week 12)
ΔHAQ
(week 12)
Reference33; −0.18
TOFA 5 mg two times per day±csDMARD107<0.01; 0.00650; −0.35
TOFA 10 mg two times per day±csDMARD104<0.001; <0.00161; −0.4
ADA 40 mg EOW±csDMARD106NR52; −0.38
Chronic plaque psoriasis
Bachelez 201535 Candidates for systemic therapy or phototherapy
+PASI >12
+PGA moderate/severe
+csDMARD-IR
LowPlacebo107Non-inferiority:
% PASI 75 (week 12)
% PGA clear/almost clear
(week 12)
6
TOFA 5 mg two times per day329NI not met
<0.001/<0.001
40
TOFA 10 mg two times per day330NI met
0.20/0.60
64
ETA 50 mg twice weekly335Reference59
  • 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.