Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naïve patients with active psoriatic arthritis (SPIRIT-P1)

Alice B Gottlieb, Vibeke Strand, Mitsumasa Kishimoto, Philip Mease, Diamant Thaçi, Julie Birt, Chin H Lee, Catherine L Shuler, Chen-Yen Lin, Dafna D Gladman, Alice B Gottlieb, Vibeke Strand, Mitsumasa Kishimoto, Philip Mease, Diamant Thaçi, Julie Birt, Chin H Lee, Catherine L Shuler, Chen-Yen Lin, Dafna D Gladman

Abstract

Objective: To report patient-reported outcomes of patients with PsA treated with ixekizumab up to 52 weeks.

Methods: In SPIRIT-P1, biologic-naïve patients with active PsA were randomized to ixekizumab 80 mg every 4 weeks (IXEQ4W; N = 107) or every 2 weeks (IXEQ2W; N = 103) following a 160 mg starting dose, adalimumab 40 mg every 2 weeks (ADA; N = 101) or placebo (PBO; N = 106) during the initial 24-week double-blind treatment period. At week 24 (week 16 for inadequate responders), ADA (8-week washout before starting ixekizumab) and PBO patients were re-randomized to IXEQ2W or IXEQ4W. Patients receiving ixekizumab at week 24 received the same dose during the extension period (EP) to week 52. Patients completed measures including the Dermatology Life Quality Index (DLQI), Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2, European Quality of Life 5 Dimensions Visual Analogue Scale and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem.

Results: The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in DLQI at week 24; 22% (PBO), 53% (IXEQ4W), 63% (IXEQ2W) and 54% (ADA) of patients reported DLQI scores of 0/1. The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2 physical component summary and some domain scores, and European Quality of Life 5 Dimensions Visual Analogue Scale at weeks 12 and 24; and in three of four Work Productivity and Activity Impairment Questionnaire-Specific Health Problem domains at week 24. Results are also presented through week 52 for the EP.

Conclusion: In biologic-naïve patients with active PsA, ixekizumab significantly improved skin symptoms, health-related quality of life and work productivity.

Trial registration: ClinicalTrials.gov, https://ichgcp.net/clinical-trials-registry/NCT01695239" title="See in ClinicalTrials.gov">NCT01695239; EU Clinical Trials Register, https://www.clinicaltrialsregister.eu, EudraCT2011-002326-49.

Figures

Fig . 1
Fig. 1
Itch NRS and DLQI in PsA patients with skin lesions affecting ≥3% BSA at baseline (A) Mean change from baseline: Itch NRS score. (B) Percentage of patients (non-responder imputation) achieving Itch NRS = 0. (C) Mean change from baseline: DLQI total score. (D) Percentage of patients (non-responder imputation) achieving DLQI = 0, 1. Study was not designed to compare active treatment groups. *P < 0.001 vs PBO; †P < 0.01 vs PBO. ADA: adalimumab; BSA: body surface area; DLQI: Dermatology Life Quality Index; IXEQ4W/Q2W: ixekizumab every 4 or 2 weeks; N: number of patients in analysis population; NRS: Numeric Rating Scale; PBO: placebo.
Fig . 2
Fig. 2
Association between PASI improvement and Itch or DLQI (A) Association between PASI improvement and Itch NRS = 0; (B) Association between PASI improvement and DLQI 0/1. Percentage of patients with a response (non-responder imputation). *P < 0.05 vs <50; †P < 0.05 vs 50 to <75. DLQI: Dermatology Life Quality Index; PASI: Psoriasis Area and Severity Index; n: number of patients in each PASI group; Total IXE: both ixekizumab dose groups combined; Total: all groups combined.
Fig . 3
Fig. 3
SF-36 domain scores Age and gender matched normative values are shown (blue). The study was not designed to compare active treatment groups. P-values from least squares mean difference comparisons active vs placebo. *P ≤ 0.05; ¥P ≤ 0.005; †P ≤ 0.001. Green, week 12; red, week 24. BP: bodily pain; GH: general health; IXEQ4W/Q2W: ixekizumab every 4 or 2 weeks; MH: mental health; norm: normative values; PF: physical functioning; RE: role emotional; RP: role physical; SF: social functioning; SF-36: 36-item short form health survey; VT: vitality; W12: week 12; W24: week 24.
Fig . 4
Fig. 4
Work productivity and activity impairment-specific health problem (A) absenteeism; (B) presenteeism; (C) work productivity; (D) activity impairment. The study was not designed to compare active treatment groups. *P ≤ 0.001 vs PBO; †P < 0.01; §P < 0.05. ADA: adalimumab; IXEQ4W/Q2W: ixekizumab every 4 or 2 weeks; N: number of patients in the analysis population; PBO: placebo; WPAI-SHP: work productivity and activity impairment-specific health problem.

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