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

Nash, Peter; Mease, Philip J.; McInnes, Iain B.; Rahman, Proton; Ritchlin, Christopher T.; Blanco, Ricardo; Dokoupilova, Eva; Andersson, Mats; Kajekar, Radhika; Mpofu, Shephard; Pricop, Luminita

doi:10.1186/s13075-018-1551-x

Table 2 Efficacy of secukinumab at weeks 24 and 52 in the overall population^a

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)
ACR20 response, n/N (%)	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)
ACR50 response, n/N (%)	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
DAS28-CRP, mean change from baseline ± SE	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)
PASI 75 response, n/N (%)^b	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
SF-36 PCS, mean change from baseline ± SE	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)
PASI 90 response, n/N (%)^b	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
HAQ-DI score, mean change from baseline ± SE	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)
Patients with resolution of dactylitis, n/N (%)^c	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)
Patients with resolution of enthesitis, n/N (%)^c	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
FACIT-Fatigue, mean change from baseline ± SE	52	6.72 ± 0.9	3.25 ± 0.9	–

Data presented as nonresponder imputation and rescue penalty (binary variables) and mixed-model repeated measures and rescue penalty (continuous variables)
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
^*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)
^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
^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
^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)

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