Table 3

Trials investigating targeted synthetic disease-modifying antirheumatic drugs in PsA

StudyPopulationRoBTreatmentnPrimary endpointP valueACR20 (%)ACR50 (%)ACR70 (%)ΔmTSSΔHAQ-DIDactylitis resolution (%)Enthesitis resolution (%)PASI75 (%)
Janus kinase inhibitors
Mease et al (EQUATOR)13 csDMARD-IRLowPlacebo±csDMARD66ACR20 (week 16)Ref33.315.26.1−0.2815
FILGO 200 mg OD±csDMARD65<0.0018047.723.1−0.5745.2
Gladman et al (OPAL Beyond)11 TNFi-IRLowPlacebo±csDMARD131ACR20 (week 12)
(week 12)
TOFA 5 mg two times per day±csDMARD131<0.001
TOFA 10 mg two times per day±csDMARD132<0.001
Mease et al (OPAL Broaden)12 csDMARD-IRLowPlacebo±csDMARD105ACR20 (week 12)
(week 12)
Ref331050.00*† 0.09*‡−0.1832.821.515
TOFA 5 mg two times per day±csDMARD107<0.01
TOFA 10 mg two times per day±csDMARD104<0.001
ADA 40 mg Q2W±csDMARD106NR523319−0.07*−0.3846.647.439
Phosphodiesterase-4 inhibitors
Cutolo et al (PALACE-2)33 csDMARD/TNF-IRUnclearPlacebo±csDMARD159ACR20 (week 16)Ref18.950.6−0.072.7
APR 20 mg two times per day±csDMARD163<0.00137.414.73.7−0.1718.8
APR 30 mg two times per day±csDMARD1620.00632.110.51.2−0.2322.1
Edwards et al (PALACE-3)34 csDMARD/TNF-IRLowPlacebo±csDMARD169ACR20 (week 16)Ref18.38.32.4−0.078
APR 20 mg two times per day±csDMARD1690.03028.412.44.7−0.1320
APR 30 mg two times per day±csDMARD167<0.00140.7153.6−0.221
Wells et al (PALACE-4)35 csDMARD-naiveUnclearPlacebo176ACR20 (week 16)Ref15.
APR 20 mg two times per day1750.0062811.44−0.1740.421.417.3
APR 30 mg two times per day1760.00130.711.44−0.2140.535.125.7
Nash et al (ACTIVE)36 bDMARD-naiveUnclearPlacebo10916Ref20.24.60−0.0633.3
APR 30 mg two times per day1100.00438.218.26.4−0.2146.4
  • *Week 52.

  • †Placebo advancing to TOFA 5 mg two times per day.

  • ‡Placebo advancing to TOFA 10 mg two times per day.

  • ACR, American College of Rheumatology; ADA, adalimumab; APR, apremilast; bDMARD, biological disease-modifying antirheumatic drug; csDMARD, conventional synthetic disease-modifying antirheumatic drug; FILGO, filgotinib; HAQ-DI, Health Assessment Questionnaire Disability Index; IR, insufficient responders; mTSS, PsA modified total Sharp score; NR, not reported; OD, once daily; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; Q2W, every 2 weeks; Ref, reference arm; RoB, risk of bias; TNF, tumour necrosis factor; TNFi, TNF inhibitor; TOFA, tofacitinib.