THU0313 Ixekizumab improves nail and skin lesions through 52 weeks in patients with active psoriatic arthritis and inadequate response to tumour necrosis factor inhibitors

Abstract

Background Ixekizumab (IXE) is a high-affinity monoclonal antibody selectively targeting interleukin-17A. Compared to placebo (PBO), IXE resulted in significantly greater reduction and clearance of fingernail and skin lesions at Wk 24 in patients (pts) with active psoriatic arthritis (PsA) and inadequate response (IR) to tumour necrosis factor inhibitors (TNF-i).1 Objectives This analysis examined the persistence of effect at 1 year. Methods In this Phase 3, double-blind trial (SPIRIT-P2; NCT02349295), pts with active PSA who were TNF-i-IR were randomised to PBO or 80 mg IXE SC every 2 or 4 Wks (IXEQ2W, IXEQ4W), after a 160 mg starting dose.2 At Wk 16, pts with IR to treatment (ERB supplement defined) received rescue therapy and pts on PBO were re-randomised to IXEQ2W or IXEQ4W. The primary objective was ACR20 at Wk 24, and an extension from Wks 24 to 156 is on-going. In this analysis, efficacy was assessed at Wk 52 for the intent-to-treat (ITT) population of pts randomised to IXE at Wk 0 by Nail Psoriasis Severity Index (NAPSI) scores in pts with baseline fingernail psoriasis (IXEQ4W, n=89; IXEQ2W, n=74), PASI 75/90/100 response rates in pts with baseline BSA ≥3 (IXEQ4W, n=68; IXEQ2W, n=68), and the rate of Static Physician Global Assessment (sPGA) of psoriasis scores of 0 or 1 (0=cleared, 1=minimal) in pts with baseline sPGA ≥3 (IXEQ4W, n=60, IXEQ2W, n=62). For categorical variables, nonresponder imputation was used for missing data. Percent change from baseline was calculated using modified baseline observation carried forward. Results At Wk 52, NAPSI total score (observed cases; mean (SD)) was 5.0 (12.7), 4.4 (7.6), IXEQ4W, IXEQ2W, respectively, with a mean percent change from baseline of −15.2 (19.7),–14.4 (19.0), IXEQ4W, IXEQ2W, respectively. The percentage of pts achieving a NAPSI score of 0 (0=cleared) was 46.1% (n=41), 32.4% (n=24), IXEQ4W, IXEQ2W, respectively. The percentage of pts achieving PASI responses was 60.3% (n=41), 54.4% (n=37) for PASI 75; 50.0% (n=34), 39.7% (n=27) for PASI 90; and 39.7% (n=27), 35.3% (n=24) for PASI 100, IXEQ4W, IXEQ2W, respectively. The percentage of pts achieving sPGA 0 or 1 was 61.7% (n=37), 66.1% (n=41), IXEQ4W, IXEQ2W, respectively. Safety was consistent with the larger study population. Conclusions In patients with active PsA, an inadequate response to TNF-inhibitors, and baseline fingernail or skin lesions, treatment with ixekizumab resulted in persistent1 reduction and clearance of nail and skin lesions after 1 year. References [1] Kristensen L, et al. Ann Rheum Dis2017;76(Suppl 2):927.[2] Nash P, et al. Lancet2017;389:2317–27. Disclosure of Interest J. F. Merola Consultant for: Merck Research Laboratories, AbbVie, Eli Lilly and Company, Novartis, Janssen, UCB, Sumumed, Celgene, Sanofi Regeneron, and GSK, Speakers bureau: AbbVie, P. Rich Grant/research support from: AbbVie, Allergan, Anacor Pharmaceuticals, Boehringer Ingelheim, Cassiopea SpA, Dermira, Eli Lilly and Company, Galderma Laboratories, Janssen-Ortho, Kadmon Corporation, Leo Pharma, Merck, Moberg Derma, Novartis, Pfizer, Ranbaxy Laboratories Limited, Sandoz, Viamet, Cellceutix, Cutanea, J. P. Dutz Grant/research support from: AbbVie, Novartis, Amgen, Consultant for: Cipher, Eli Lilly and Company, Speakers bureau: Janssen, AbbVie, Novartis, Amgen, Leo Pharma, Celgene, D. Adams Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, L. Kerr Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, L. E. Kristensen Grant/research support from: UCB, Biogen, Janssen Pharmaceuticals, Novartis, Speakers bureau: Pfizer, AbbVie, Amgen, UCB, Bristol-Myers Squibb, Biogen, MSD, Novartis, Eli Lilly and Company, Janssen Pharmaceuticals.