Table 2

Trials investigating non-TNF biological disease-modifying antirheumatic drugs in PsA

StudyPopulationRoBTreatmentnPrimary endpointP valueACR20 (%)ACR50 (%)ACR70 (%)ΔmTSSΔHAQ-DIDactylitis resolution (%)Enthesitis resolution (%)PASI75 (%)
IL-17A inhibitors
Mease et al (SPIRIT-P1)1 csDMARD-IRLowPlacebo±csDMARD106ACR20 (week 24)Ref30.215.15.70.49−0.182519.310.4
IXE 80 mg Q4W±csDMARD107<0.00157.940.223.40.17−0.4479.542.671.2
IXE 80 mg Q2W±csDMARD103<0.00162.146.6340.08−0.576.938.679.7
ADA 40 mg Q2W±csDMARD101<0.00157.438.625.70.1−0.3777.833.354.4
Nash et al
(SPIRIT-P2)2
TNFi-IRLowPlacebo±csDMARD118ACR20 (week 24)Ref19.55.10−0.28.5
IXE 80 mg Q4W±csDMARD122<0.00153.335.222.1−0.631.1
IXE 80 mg Q2W±csDMARD123<0.0014833.312.2−0.433.3
Nash et al
(FUTURE-3)3
Mixed csDMARD/bDMARD-IRLowPlacebo±MTX137ACR20 (week 24)Ref16.18.8−0.1713.915.310.2
SEC 300 mg without LD±MTX139<0.00148.234.5−0.3847.839.846.8
SEC 150 mg without LD±MTX138<0.0014218.8−0.2738.936.850
Kivitz et al
(FUTURE-4)4
NSAID-IRAbstractPlacebo±MTX114ACR20 (week 16)Ref18.46.18.18.1
SEC 150 mg with LD±MTX114<0.00141.222.82.552.7
SEC 150 mg without LD±MTX113<0.00139.816.817.250
Mease et al
(FUTURE-5)5
MixedLowPlacebo±MTX332ACR20 (week 16)Ref27.48.14.20.5*−0.2132.335.412.3
SEC 300 mg with LD±MTX222<0.00162.639.620.30.08*−0.5565.955.770
SEC 150 mg with LD±MTX220<0.00155.535.918.20.17*−0.4457.554.660
SEC 150 mg without LD±MTX222<0.00159.53214.9−0.09*−0.4556.341.958.1
IL-23p19 inhibitors
Deodhar et al 6 Mixed csDMARD/TNFi-IRLowPlacebo±MTX49ACR20 (week 24)Ref18102−0.06172913
GKM 100 mg±MTX100<0.001583414−0.42555779
Mease et al (ACR)7 Mixed MTX/TNFi-IRAbstractPlacebo±MTX42ACR20 (week 16)Ref35.711.900.6*−0.099.5
RKM 150 mg Q4W±MTX42<0.0557.123.814.3−0.3*−0.1875.0
RKM 150 mg weeks 0, 4 and 16±MTX42<0.0161.923.87.10.2*−0.1670.0
RKM 150 mg weeks 0 and 12±MTX39<0.0559.038.525.6−0.5*−0.2573.9
RKM 75 mg week 0±MTX20<0.0565.025.015.0−0.2*−0.1666.7
Other bDMARDs
Mease et al 9 NSAID/csDMARD-IRLowPlacebo±MTX4116Ref29.37.30.1−0.2714.6
CKM 25 mg±MTX410.10146.329.328.6−0.4412.2
CKM 100 mg±MTX420.03952.435.724.9−0.416.7
CKM 200 mg±MTX410.1783917.116.5−0.264.9
Mease et al
(ASTRAEA)8
Mixed csDMARD/TNFi-IRLowPlacebo±MTX211ACR20 (week 24)Ref22.319.210.30.3−0.23421.210.1
ABA±MTX213<0.00139.412.36.60.35−0.3344.332.916.4
Mease et al 10 MTX-IRLowPlacebo+MTX24ACR20 (week 12)Ref2512.54.2−0.2827
ADA 40 mg Q2W+MTX72NR68.137.515.3−0.5857.6
ABT-122 120 mg Q2W71<0.00164.836.622.5−0.5574.4
ABT-122 240 mg Q2W73<0.00175.353.431.5−0.5677.6
  • *Week 24.

  • ABA, abatacept; ACR, American College of Rheumatology; ADA, adalimumab; bDMARD, biological disease-modifying antirheumatic drug; CKM, clazakizumab; csDMARD, conventional synthetic disease-modifying antirheumatic drug; GKM, guselkumab; HAQ-DI, Health Assessment Questionnaire Disability Index; IL, interleukin; IR, insufficient responders; IXE, ixekizumab; LD, loading dose; mTSS, PsA modified total Sharp score; MTX, methotrexate; NR, not reported; NSAID, non-steroidal anti-inflammatory drug; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; Ref, reference arm; RKM, risankizumab; RoB, risk of bias; SEC, secukinumab; TNF, tumour necrosis factor; TNFi, TNF inhibitor.