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SAT0470 Secukinumab provides sustained improvements in the signs and symptoms of active psoriatic arthritis: 3-year efficacy and safety results from phase 3 future 1 trial
  1. PJ Mease1,
  2. A Kavanaugh2,
  3. A Reimold3,
  4. H Tahir4,
  5. J Rech5,
  6. S Hall6,
  7. P Geusens7,8,
  8. P Pascale9,
  9. EM Delicha9,
  10. L Pricop10,
  11. S Mpofu9,
  12. on behalf of the FUTURE 1 study group
  1. 1Swedish Medical Centre and University of Washington, Seattle
  2. 2UC San Diego School of Medicine, la Jolla
  3. 3University of Texas Southwestern Medical Center, Dallas, United States
  4. 4Barts Health NHS Trust, London, United Kingdom
  5. 5University of Erlangen-Nuremberg, Erlangen, Germany
  6. 6Monash University, Melbourne, Australia
  7. 7University of Hasselt, Hasselt, Belgium
  8. 8Maastricht University Hospital, Maastricht, Netherlands
  9. 9Novartis Pharma AG, Basel, Switzerland
  10. 10Novartis Pharmaceuticals Corporation, East Hannover, United States

Abstract

Background Secukinumab significantly improved the signs and symptoms of psoriatic arthritis (PsA) over 2 years (yrs) in the FUTURE 1 study.1

Objectives To report efficacy and safety of secukinumab through 3 yrs in an extension of the FUTURE 1 study (NCT01892436).

Methods After 2-yr core trial, patients (pts) receiving secukinumab 150/75mg s.c. entered the 3-yr extension phase. Efficacy results at Week (Wk) 156 are presented for those pts originally randomised to secukinumab (n=308) and included ACR20/50/70, PASI 75, DAS28-CRP, SF-36 PCS, HAQ-DI, dactylitis and enthesitis. Multiple imputation was used for analysis of binary variables while continuous variables are reported as observed. Analyses by anti-TNF status (naïve/inadequate response) were prespecified and reported as observed. Safety analysis included all pts (n=587) who received ≥1 dose of secukinumab.

Results Overall, 457 of the original 606 pts entered the extension study of which 435 (95.2%) pts completed 156 wks (151 [93.8%] pts in IV→150 mg group; 142 [96.6%] in IV→75 mg group; 142 [95.3%] in PBO→ secukinumab groups). Sustained clinical improvements through Wk 156 were observed across all endpoints and were seen regardless of prior anti-TNF use (Table 1). Over the entire study period (mean [±SD] exposure to secukinumab of 1025.1±372.7 days), the exposure-adjusted incidence rate with secukinumab for serious infections/infestations, candida infections, Crohn's disease, and malignant/unspecified tumors was 1.7 (27), 1.2 (17), 0.1 (2), and 0.9 (14) per 100 pt-yrs, respectively.

Table 1.

Summary of efficacy results at Week 156

Conclusions Secukinumab provided sustained improvements in signs/symptoms and across multiple clinical domains of active PsA in pts who completed 3 yrs of therapy. Secukinumab was well tolerated with a favorable safety profile consistent with that previously reported.1

References

  1. Kavanaugh A, et al. Arthritis Care Res. (Hoboken) 2016.

References

Disclosure of Interest 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, A. Kavanaugh Consultant for: Novartis, A. Reimold Grant/research support from: AbbVie, H. Tahir Speakers bureau: Novartis, Eli Lilly, and Abbvie, J. Rech Speakers bureau: Abbvie, BMS, Celgene, Fresenius, medicap, MSD, Novartis, Pfizer, and Roche, S. Hall: None declared, P. Geusens Grant/research support from: Pfizer, Abbott, Lilly, Amgen, MSD, Will, Bio Minerals and Roche, Speakers bureau: Pfizer, Abbott, Lilly, Amgen, MSD, Will, Bio Minerals and Roche, P. Pascale Shareholder of: Novartis, Employee of: Novartis, E. M. Delicha Employee of: Novartis, L. Pricop Shareholder of: Novartis, Employee of: Novartis, S. Mpofu Shareholder of: Novartis, Employee of: Novartis

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