MTX9 | CSA19 | LFN17 | ADA28 | ADA23 ADEPT | ADA29 | ETA20 | INF31 IMPACT | INF30 IMPACT 2 | GOL34 | CZP37 | UST39 | ABAT39 | Apremilast52 | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Patients (n) on treatment/control | 16/19 | 38/34 | 95/91 | 51/49 | 151/162 | 58/55 | 101/104 | 52/52 | 100/100 | 146/113 | 138/136 | 76/70 | 40/42 | 67/68 |
Mean dose | 10 mg / wIM | 2.5–4 mg/k/d | 20 mg/d | 40 mg eow | 40 mg eow | 40 mg eow | 25 mg biw | 5 mg/kg | 5 mg /kg | 50 mg/mo | 200 q2w | 90 mg qw | 10 mg/kg | 20 mg bid, 40 mg qd |
Comparator | NSAID | PBO | PBO | PBO | PBO | CSA 2.5–3.75mg/kg/d +ADA | PBO | PBO | PBO | PBO | PBO | PBO | PBO | PBO |
Followup, weeks | 24 | 48 | 24 | 12 | 24 | 48 | 24 | 16 | 24 | 24 | 24 | 12 | 24 | 12 |
Tender joint score, ES | 0.22 | |||||||||||||
Swollen joint score, ES | 0.17 | |||||||||||||
Pain, VAS; ES | –0.15 | 0.26 | 0.64 | 0.94 | 1.74 | 1.96 | ||||||||
HAQ, ES | –0.18 | 0.29 | 0.49 | 0.67 | 0.87 | 1.17 | 0.65 | 0.65 | ||||||
Tender joint count, 0–78; ES | 0.25 | 1.14 | 1.14 | |||||||||||
Swollen joint count, 0–76; ES | 0.33 | 0.13 | 0.3 | 1.17 | 0.81 | |||||||||
ACR20, NNT | 5 | 3 | 3 | 2 | 3 | 3 | 3 | 4 | 4 | 4 bid 5 qd | ||||
PsARC, NNT | 4 | 10 | ||||||||||||
Primary endpoint | Joint | Tender Index (Ritchie) | PsARC | ACR20 wk 12 | ACR20 wk 12 and x-ray | PsARC 12 mo | ACR20 wk 12 | ACR20 wk 16 | ACR20 wk 14 | ACR20 wk 14 and vdH-S wk 24 | ACR20 wk 12 and x-ray | ACR20 wk 12 | ACR20 day 169 | ACR20 wk 12 |
MTX: methotrexate; CSA: cyclosporine; LFN: leflunomide; ADA: adalimumab; ETA: etanercept, INF: infliximab; GOL: golimumab; CZP: certolizumab pegol; UST: ustekinumab; ABAT: abatacept; ES: effect size; NNT: number needed to treat; ACR20: American College of Rheumatology 20% response; PsARC: Psoriatic Arthritis Response Criteria; VAS: visual analog scale; vdH-S Sharp/van der Heijde score; eow: every other week; biw: twice weekly; q2w: every 2 weeks; q4w: every 4 weeks; bid: twice/daily; qd : once daily.