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Table 2 Efficacy of secukinumab at weeks 24 and 52 in the overall populationa

From: Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3)

Endpoint Week Secukinumab 300 mg (N = 139) Secukinumab 150 mg (N = 138) Placebo (N = 137)
ACR20 response, n/N (%) 24 67/139 (48.2)* 58/138 (42.0)* 22/137 (16.1)
52 81/139 (58.3) 65/138 (47.1)
ACR50 response, n/N (%) 24 48/139 (34.5)* 26/138 (18.8) 12/137 (8.8)
52 46/139 (33.1) 38/138 (27.5)
DAS28-CRP, mean change from baseline ± SE 24 −1.56 ± 0.09* −1.24 ± 0.1 −0.64 ± 0.13
52 −1.61 ± 0.09 −1.41 ± 0.10
PASI 75 response, n/N (%)b 24 29/62 (46.8)* 34/68 (50.0) 6/59 (10.2)
52 46/62 (74.2) 41/68 (60.3)
SF-36 PCS, mean change from baseline ± SE 24 6.46 ± 0.59§ 3.42 ± 0.60 2.94 ± 0.83
52 6.43 ± 0.66 4.49 ± 0.68
PASI 90 response, n/N (%)b 24 21/62 (33.9)§ 25/68 (36.8) 4/59 (6.8)
52 34/62 (54.8) 28/68 (41.2)
HAQ-DI score, mean change from baseline ± SE 24 − 0.38 ± 0.04§ − 0.27 ± 0.04 −0.17 ± 0.06
52 −0.43 ± 0.05 −0.30 ± 0.05
Patients with resolution of dactylitis, n/N (%)c 24 22/46 (47.8)§ 14/36 (38.9) 5/36 (13.9)
52 28/46 (60.9) 19/36 (52.8)
Patients with resolution of enthesitis, n/N (%)c 24 35/88 (39.8)§ 35/95 (36.8) 15/98 (15.3)
52 47/88 (53.4) 44/95 (46.3)
Patient’s assessment of PsA pain (VAS), mean change from baseline ± SE 24 −18.23 ± 1.97* −12.46 ± 2.0 −3.75 ± 2.81
52 −20.3 ± 2.1 −11.8 ± 2.2
FACIT-Fatigue, mean change from baseline ± SE 24 6.40 ± 0.78 2.73 ± 0.80 2.07 ± 1.05
52 6.72 ± 0.9 3.25 ± 0.9
  1. Data presented as nonresponder imputation and rescue penalty (binary variables) and mixed-model repeated measures and rescue penalty (continuous variables)
  2. ACR20/50 20%/50% improvement in American College of Rheumatology response criteria; BSA body surface area, DAS28-CRP 28-joint Disease Activity Score using C-reactive protein, FACIT-Fatigue Functional Assessment of Chronic Illness Therapy—Fatigue, HAQ-DI Health Assessment Questionnaire—Disability Index, N number of patients, PASI Psoriasis Area Severity Index, PsA psoriatic arthritis, SE standard error, SF-36 PCS Short Form-36 Physical Component Summary, VAS visual analog scale
  3. *p < 0.0001, p < 0.001, §p < 0.01, p < 0.05 versus placebo. p values adjusted for multiplicity of testing for overall population data (except for pain and FACIT-Fatigue)
  4. aPrespecified primary and secondary endpoints were analyzed according to a statistical hierarchy except for pain and FACIT-Fatigue. Endpoints are shown in the order of testing
  5. bPASI 75 and PASI 90 denote improvements of 75% and 90%, respectively, in the score on the Psoriasis Area Severity Index. Assessed in patients with psoriasis on at least 3% of their BSA
  6. cResolution of dactylitis and enthesitis among those patients with these symptoms at baseline: dactylitis, N = 46 (300 mg), 36 (150 mg), and 36 (placebo); enthesitis, N = 88 (300 mg), 95 (150 mg),and 98 (placebo)