Table 2

Comparison of efficacy during the 24 weeks of placebo-controlled therapy

	Placebo		IXEQ4W		IXEQ2W		Adalimumab 40 mg Q2W*
	12 weeks	24 weeks	12 weeks	24 weeks	12 weeks	24 weeks	12 weeks	24 weeks
Responder rate:
	N=106		N=107		N=103		N=101
ACR20, %	31.1	30.2	57.0†	57.9†	60.2†	62.1†	51.5‡	57.4†
ACR50, %	4.7	15.1	33.6†	40.2†	39.8†	46.6†	29.7†	38.6†
ACR70, %	0	5.7	15.0	23.4†	16.5	34.0†	17.8	25.7†
	N=92		N=100		N=90		N=89
HAQ-DI MCID, %§	29.3	26.1	49.0‡	49.0†	64.4†	57.8†	49.4‡	49.4†
	N=28		N=39		N=26		N=18
LDI-B (0), %¶,**	53.6	25.0	74.4	79.5†	69.2	76.9†	61.1	77.8†
	N=57		N=68		N=57		N=54
LEI (0), %¶,††	28.1	19.3	27.9	42.6‡	47.4‡‡	38.6§§	35.2	33.3
	N=67		N=73		N=59		N=68
PASI 75, %¶¶	7.5	10.4	75.3†	71.2†	69.5†	79.7†	33.8†	54.4†
PASI 90, %¶¶	1.5	6.0	52.1†	56.2†	57.6†	67.8†	22.1‡	36.8†
PASI 100, %¶¶	1.5	3.0	31.5†	42.5†	40.7†	52.5†	14.7§§	23.5‡
	N=41		N=52		N=41		N=37
sPGA (0, 1), %***	7.3	17.1	75.0†	65.4†	80.5†	73.2†	45.9†	62.2†
sPGA (0), %***	2.4	2.4	30.8‡	38.5‡	36.6‡	39.0‡	10.8	18.9‡‡
	N=74		N=70		N=74		N=71
NAPSI (0), %†††	8.1	18.9	20.0‡‡	25.7	27.0‡	36.5§§	19.7‡‡	39.4‡
LS mean change from baseline (SE):
	N=106		N=107		N=103		N=101
DAS28-CRP	−0.57 (0.11)	−0.84 (0.13)	−1.63 (0.11)†	−1.96 (0.12)†	−1.67 (0.11)†	−2.04 (0.12)†	−1.57 (0.12)†	−1.74 (0.12)†
	N=106		N=107		N=103		N=101
HAQ-DI	−0.13 (0.05)	−0.18 (0.05)	−0.37 (0.05)†	−0.44 (0.05)†	−0.47 (0.05)†	−0.50 (0.05)†	−0.35 (0.05)†	−0.37 (0.05)‡
	N=106		N=107		N=103		N=101
SF-36 PCS	2.3 (0.8)	2.9 (1.0)	5.8 (0.8)†	7.5 (0.9)†	7.6 (0.8)†	8.2 (0.9)†	5.7 (0.8)†	6.8 (0.9)‡
	N=28		N=39		N=26		N=18
LDI-B¶,**	−36.3 (10.3)	−33.7 (9.7)	−72.8 (8.8) †	−75.4 (8.1)†	−63.9 (10.6)‡‡	−66.1 (9.8)‡	−62.1 (11.9)	−76.0 (10.9)†
	N=57		N=70		N=59		N=56
LEI‡‡‡	−0.8 (0.24)	−0.8 (0.26)	−0.9 (0.21)	−1.3 (0.21)	−1.5 (0.24)‡‡	−1.4 (0.24)	−0.8 (0.24)	−0.9 (0.23)
	N=102		N=100		N=95		N=97
% BSA§§§	−1.6 (1.2)	−2.7 (1.4)	−10.4 (1.2)†	−12.0 (1.3)†	−8.8 (1.2)†	−10.6 (1.4)†	−7.7 (1.2)†	−9.5 (1.4)†
	N=74		N=70		N=74		N=71
NAPSI†††	−1.1 (1.4)	−2.4 (1.7)	−8.4 (1.5)†	−14.0 (1.5)†	−7.7 (1.4)†	−15.5 (1.5)†	−6.8 (1.4)‡	−10.7 (1.5)†

*The adalimumab 40 mg Q2W treatment arm served as active reference for comparison with placebo. The study was not powered to test equivalence or non-inferiority of ixekizumab versus adalimumab.
†p≤0.001 vs placebo.
‡p≤0.01 vs placebo.
§Data reported for patients with a baseline HAQ-DI score ≥0.35. The MCID for HAQ-DI is an improvement from baseline ≥0.35.
¶Post hoc analysis.
**Data are reported for patients with dactylitis, as qualitatively assessed by the investigator, at baseline and baseline LDI-B score >0.
††Data are reported for patients with enthesitis, as qualitatively assessed by the investigator, at baseline and baseline LEI score >0.
‡‡p<0.05 vs placebo.
§§p≤0.025 vs placebo.
¶¶Data are reported for patients with baseline psoriatic lesion(s) involving ≥3% BSA.
***Data are reported for patients with sPGA ≥3 at baseline.
†††Data are reported for patients with fingernail psoriasis, as qualitatively assessed by the investigator, at baseline.
‡‡‡Data are reported for patients with enthesitis, as qualitatively assessed by the investigator, at baseline.
§§§Data are reported for patients with psoriasis, as qualitatively assessed by the investigator, at baseline.
ACR20/50/70, 20/50/70% American College of Rheumatology response; BSA, body surface area; DAS28-CRP, 28-joint Disease Activity Score using C reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; IXEQ2W, 80 mg ixekizumab once every 2 weeks; IXEQ4W, 80 mg ixekizumab once every 4 weeks; LDI-B, Leeds Dactylitis Index-Basic; LEI, Leeds Enthesitis Index; LS, least squares; MCID, minimal clinically important difference; NAPSI, Nail Psoriasis Severity Index; PASI 75/90/100, Psoriasis Area and Severity Index Improvement Response for 75/90/100%; Q2W, every 2 weeks; SF-36 PCS, Short Form (36 Items) Health Survey Physical Component Score; sPGA, static Physician Global Assessment of psoriasis.