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FRI0451 Secukinumab Provides Rapid and Sustained Reductions in Dactylitis and Enthesitis in Patients with Psoriatic Arthritis: Analysis of Data from The Phase 3 Randomised, Multicentre, Double-Blind, Placebo-Controlled Future 2 Study
  1. B. Kirkham1,
  2. P. Mease2,
  3. I. McInnes3,
  4. V. Bhosekar4,
  5. S. Mpofu5,
  6. K. Gandhi6,
  7. C. Gaillez5
  1. 1Guy's and St Thomas' NHS, London, United Kingdom
  2. 2Swedish Medical Centre and University of Washington, Seattle, United States
  3. 3University of Glasgow, Glasgow, United Kingdom
  4. 4Novartis Healthcare Pvt Ltd, Hyderabad, India
  5. 5Novartis Pharma AG, Basel, Switzerland
  6. 6Novartis Pharmaceuticals Corporation, East Hanover, United States

Abstract

Background Dactylitis and enthesitis are common debilitating manifestations of psoriatic arthritis (PsA).1 Secukinumab has previously been reported to reduce the number of dactylitic digits and enthesitis sites in patients (pts) with PsA, with a greater proportion of pts achieving complete resolution of dactylitis and enthesitis than placebo (PBO) at Week (Wk) 24.2,3

Objectives To evaluate the effects of secukinumab on dactylitis and enthesitis through Wk 52 in FUTURE 2 (NCT01752634).

Methods The study design from FUTURE 2 has been reported previously.2 The proportions of pts with resolution of dactylitis and enthesitis at Wk 24 and Wk 52 were secondary and exploratory endpoints, respectively; additional measures were dactylitic digit and enthesitis counts. Post-hoc analyses included Kaplan Meier (KM) analysis to achieve resolution of enthesitis and dactylitism and proportion of pts with resolution of dactylitis and enthesitis by baseline (BL) severity.

Results Of the 397 pts randomized, 138 (35%) and 253 (64%) had dactylitis and enthesitis, respectively, at BL. KM curves indicate that median time to resolution in dactylitis and enthesitis was Wk 4 for secukinumab 300 and 150 mg. At Wk 24, a greater proportion of secukinumab-treated pts achieved complete resolution of dactylitis and enthesitis than PBO (P<0.05); more secukinumab-treated pts had complete resolution of symptoms at Wk 52 than Wk 24. Improvements at Wk 24 and 52 were observed regardless of BL severity. A sustained decrease in mean changes from BL to Wk 24 and 52 in dactylitis and enthesitis count were shown in those pts with symptoms at BL (Table), with improvements versus PBO observed by Wk 4 (P<0.05).

Table 1.

Dactylitis and Enthesitis Data at Wks 24 and 52

Conclusions Secukinumab demonstrated a rapid resolution of dactylitis and enthesitis as early as Wk 4 and this was sustained up to Wk 52. A higher proportion of pts achieved complete resolution and reduced mean counts of dactylitis and enthesitis at Wk 52 than Wk 24.

  1. Gladman et al. Ann Rheum Dis 2005;64:14–7;

  2. McInnes et al. Lancet 2015;386:1137–46;

  3. Kirkham et al. Ann Rheum Dis 2015;74:351

Disclosure of Interest B. Kirkham Grant/research support from: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Roche, UCB, Consultant for: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Roche, UCB, Speakers bureau: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Roche, UCB, P. Mease Grant/research support from: Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, Consultant for: Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, I. McInnes Grant/research support from: Abbvie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB, Consultant for: Abbvie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB, V. Bhosekar: None declared, S. Mpofu Shareholder of: Novartis, Employee of: Novartis, K. Gandhi Employee of: Novartis, C. Gaillez Shareholder of: Novartis, Employee of: Novartis

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