Summary of clinical efficacy through week 104, data as observed
| Efficacy end points | Week 16 | Week 52 | Week 104 | ||||||
| 300 mg (N=222) | 150 mg (N=220) | 150 mg no load (N=222) | 300 mg (N=222) | 150 mg (N=220) | 150 mg no load (N=222) | 300 mg (N=222) | 150 mg* group (N=220) | 150 mg* no load group (N=222) | |
| ACR70 response, % (n) | 21.2 (212) | 19.0 (211) | 15.6 (211) | 31.8 (201) | 29.1 (196) | 28.9 (190) | 34.8 (187) | 33.1 (175) | 44.0 (168) |
| PASI 90 response†, % (n) | 54.6 (108) | 38.0 (121) | 32.7 (113) | 61.8 (102) | 52.7 (112) | 47.1 (102) | 70.1 (97) | 59.2 (103) | 62.6 (91) |
| PASI 100 response†, % (n) | 34.3 (108) | 22.1 (122) | 19.5 (113) | 48.0 (102) | 36.3 (113) | 35.3 (102) | 49.5 (97) | 44.2 (104) | 40.7 (91) |
| DAS28-CRP score, mean change from BL±SD (n) | −1.5±1.3 (209) | −1.4±1.2 (208) | −1.3±1.2 (210) | −1.9±1.2 (201) | −1.8±1.1 (194) | −1.9±1.3 (189) | −2.1±1.2 (182) | −2.1±1.1 (172) | −2.2±1.1 (165) |
| HAQ-DI score, mean change from BL±SD (n) | −0.55±0.57 (211) | −0.46±0.55 (210) | −0.49±0.57 (211) | −0.58±0.6 (199) | −0.53±0.6 (195) | −0.60±0.7 (190) | −0.58±0.6 (186) | −0.57±0.6 (177) | −0.62±0.7 (169) |
| Enthesitis resolution‡, % (n) | 56.5 (138) | 56.2 (137) | 44.3 (122) | 78.0 (127) | 69.0 (129) | 68.7 (115) | 78.0 (118) | 80.3 (117) | 69.5 (95) |
| Dactylitis resolution‡, % (n) | 66.7 (81) | 58.2 (79) | 58.0 (100) | 80.6 (72) | 82.9 (70) | 81.6 (87) | 82.8 (64) | 85.5 (62) | 89.3 (75) |
Results are reported as observed data.
*150 mg groups include patients who escalated to 300 mg.
†Analysis performed in randomised patients with psoriasis (psoriasis subset) affecting ≥3% body surface area at baseline; n=110 (300 mg), 125 (150 mg) and 117 (150 mg no load).
‡Resolution of enthesitis and dactylitis is shown for patients with symptoms at baseline.
%, percentage of responses; ACR, American College of Rheumatology response criteria; BL, baseline; DAS28-CRP, 28-joint Disease Activity Score using C reactive protein; HAQ-DI, HAQ–Disability Index; n, number of patients in the treatment group with evaluation at weeks 16, 52 and 104; N, number of randomised patients; PASI, Psoriasis Area and Severity Index.