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, http://clinicaltrials.gov, NCT01695239; EU Clinical Trials Register, https://www.clinicaltrialsregister.eu, EudraCT2011-002326-49
| Original language | English |
|---|---|
| Journal | Rheumatology (United Kingdom) |
| Volume | 57 |
| Issue number | 10 |
| Pages (from-to) | 1777-1788 |
| Number of pages | 12 |
| ISSN | 1462-0324 |
| DOIs | |
| Publication status | Published - 01.10.2018 |
Funding
Funding: This work was supported by Eli Lilly and Company. Disclosure statement: A.B.G. reports consulting/advisory board agreements with Janssen, Celgene, Bristol Myers Squibb, Beiersdorf, AbbVie, UCB, Novartis, Incyte, Eli Lilly and Company, Dr Reddy’s Labs, Valeant, Dermira, Allergan and Sun Pharmaceutical Industries. She reports research/educational grants from Janssen, Eli Lilly and Company, Novartis, LEO Pharma, Allergan, and Incyte. V.S. reports consulting fees from Eli Lilly and Company, AbbVie, Amgen, Anthera, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, Regeneron, Sanofi and UCB. M.K. served on advisory boards of and received honoraria from Eli Lilly and Company. P.M. reports Grant/research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen, Eli Lilly and Company, Novartis, Pfizer, SUN Pharma, UCB Pharma; he served as a consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Merck, Novartis, Pfizer, SUN Pharma, UCB Pharma; speaker’s bureau for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Genentech, Janssen, Pfizer, UCB Pharma. D.T. has received personal fees and non-financial support from Eli Lilly and Company, received honoraria from AbbVie, Almiral, Amgen, Biogen-Idec, Celgene, Dignity, Dr Reddy’s Laboratory, Galapagos, Galderma, Janssen, LEO Pharma, Maruho, Mitsubishi, Eli Lilly and Company, Novartis, Pfizer, Sandoz-Hexal, Regeneron/Sanofi, UCB and XenoPort for participation in advisory boards, as a speaker, and for consultancy and received research grants from AbbVie, Biogen-Idec, Celgene and Novartis. D.D.G. has consulted for or received grant support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer and UCB. J.B. and C-Y.L. are full-time employees of Eli Lilly and Company and are minor stockholders. C.L.S. was a full-time employee of Eli Lilly and Company and a minor stockholder at the time this article was written. C.H.L. was an employee of Eli Lilly and Company and a minor stockholder at the time that this article was written. He is currently an employee of Genentech, Inc., and is still a minor stockholder of Eli Lilly and Company.
Research Areas and Centers
- Academic Focus: Center for Infection and Inflammation Research (ZIEL)
