Article Text

PDF
SAT0463 Secukinumab provides sustained reduction in fatigue in patients with active psoriatic arthritis through 3 years: long-term data from the future 1 and future 2 studies
  1. L Gossec1,
  2. TK Kvien2,
  3. PG Conaghan3,
  4. M Østergaard4,
  5. D Gladman5,
  6. P Mease6,
  7. L Rasouliyan7,
  8. L Pricop8,
  9. C Gaillez9,
  10. S Jugl9
  1. 1UPMC University Paris 06, Paris, France
  2. 2Diakonhjemmet Hospital, Oslo, Norway
  3. 3University of Leeds, Leeds, United Kingdom
  4. 4Copenhagen Center for Arthritis Research (COPECARE), Glostrup, Denmark
  5. 5University of Toronto, Toronto, Canada
  6. 6Swedish Medical Center, Seattle, WA, United States
  7. 7RTI Health Solutions, Barcelona, Spain
  8. 8Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States
  9. 9Novartis Pharma AG, Basel, Switzerland

Abstract

Background Fatigue, a common symptom in patients (pts) with PsA, can negatively impact HRQoL and social functioning. Secukinumab (SEC), a fully human anti–IL-17A mAb, rapidly improved signs and symptoms, physical functioning, HRQoL, and fatigue in pts with PsA.1,2

Objectives To assess the long-term effects of SEC on fatigue in TNF inhibitor (TNF)-naïve PsA pts and those with an inadequate response or intolerance to TNF inhibitor therapy (TNF-IR).

Methods 606 and 397 pts were randomized to SEC or placebo (PBO) in FUTURE 1 (10 mg/kg IV followed by 150 or 75 mg SC) and FUTURE 2 (300, 150, or 75 mg SC), respectively. At Wk 16, PBO pts with ≤20% reduction in tender/swollen joint count (non-responders) were re-randomized to SEC 150 or 75 mg SC (FUTURE 1) and SEC 300 or 150 mg SC (FUTURE 2); responders were re-randomized at Wk 24. Pts in FUTURE 1 could enter a LTE study at Wk 104 (NCT01892436). Across both studies, approximately 68% of pts were TNF-naïve and 32% were TNF-IR. Fatigue was assessed at baseline (BL) and Wks 4, 8, 12, 16, 24, 52, 104, and 156 (FUTURE 1 only) using FACIT-F (higher scores = less fatigue). Fatigue response was defined by an increase in FACIT-F score of ≥4 from BL (corresponding to the MCID). Correlations between BL characteristics and improvements in fatigue were investigated using a logistical regression model. Only data with approved doses of SEC (300/150 mg) are shown.

Results FACIT-F was 27.8–28.9 and 26.6–29.2 at BL across groups in FUTURE 1 and 2, respectively. Improvements in fatigue seen with all doses of SEC vs. PBO from Wks 4–24 were sustained through 156 wks in FUTURE 1 and 104 wks in FUTURE 2 in both the overall population and subgroups stratified by prior exposure to TNF (Table). The numerically higher responses with SEC 150 vs. 300 mg in this observed analysis were as a result of a higher rate of discontinuation due to lack of efficacy with the lower dose, which inflated the response rate. In the overall population, the LS mean change (±SEM) from BL in FACIT-F was significantly greater with SEC vs. PBO at Wk 16 in both FUTURE 1 (7.25±0.72 vs. 4.07±0.76; P=0.002) and FUTURE 2 (300 mg: 5.89±0.92 vs. 1.86±0.93, P=0.002; 150 mg: 7.40±0.90 vs. 1.86±0.93, P<0.0001); improvements were sustained throughout the entire follow up in both studies (FUTURE 1 Wk 156: 6.14±0.77; FUTURE 2 Wk 104: 300 mg 7.29±1.04, 150 mg 7.02±1.06). Improvements were generally somewhat larger in TNF-naïve pts than in TNF-IR pts. Correlation analyses did not identify any BL factors that consistently predicted change in fatigue score across Wks 16, 52, and 104.

Conclusions SEC-treated PsA pts achieved rapid, sustained, and clinically meaningful improvements in fatigue for up to 156 wks, with higher responses in TNF-naïve pts.

References

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

  2. Mease et al. N Engl J Med 2015;373:1329–39.

References

Disclosure of Interest L. Gossec Grant/research support from: BMS, Lippy, Pfizer; Consultant for: Abbvie, BMS, Celgene, Janssen, MSD, Novartis, Pfizer, Roche and UCB, T. Kvien Consultant for: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz and UCB, Speakers bureau: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz and UCB, P. Conaghan Consultant for: Abbvie, BMS, Lilly, Novartis, Pfizer, Roche, Speakers bureau: Abbvie, BMS, Lilly, Novartis, Pfizer, Roche, M. Østergaard Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Janssen, Merck, Novartis, Orion, Pfizer, Regeneron, Roche, UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Janssen, Merck, Novartis, Orion, Pfizer, Regeneron, Roche, UCB, D. Gladman Grant/research support from: Abbvie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Consultant for: Abbvie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, P. Mease Grant/research support from: Abbvie, Amgen, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Janssen, Merch, Novartis, Pfizer, SUN, UCB, Consultant for: Abbvie, Amgen, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Janssen, Merch, Novartis, Pfizer, SUN, UCB, Speakers bureau: Abbvie, Amgen, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Janssen, Merch, Novartis, Pfizer, SUN, UCB, L. Rasouliyan Consultant for: Novartis, L. Pricop Shareholder of: Novartis, Employee of: Novartis, C. Gaillez Shareholder of: Novartis and BMS, Employee of: Novartis, S. Jugl Shareholder of: Novartis, Employee of: Novartis

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.