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Original article
Body mass index and treatment response to subcutaneous abatacept in patients with psoriatic arthritis: a post hoc analysis of a phase III trial
  1. Iain B McInnes1,
  2. Gianfranco Ferraccioli2,
  3. Maria-Antonietta D'Agostino3,
  4. Manuela Le Bars4,
  5. Subhashis Banerjee5,
  6. Harris A Ahmad5,
  7. Yedid Elbez6 and
  8. Philip J Mease7
  1. 1Institute of Infection, Immunity & Inflammation, University of Glasgow, Glasgow, UK
  2. 2Division of Rheumatology, IRCCS—Fondazione Policlinico Universitario A. Gemelli—Catholic University of the Sacred Heart, Rome, Italy
  3. 3Rheumatology, Université Versailles Saint-Quentin en Yvelines, Ambroise Paré Hospital, APHP, Boulogne-Billancourt, France
  4. 4Bristol-Myers Squibb, Rueil-Malmaison, France
  5. 5Bristol-Myers Squibb, Princeton, New Jersey, USA
  6. 6Excelya, Boulogne-Billancourt, France
  7. 7Swedish Medical Center and University of Washington, Seattle, Washington, USA
  1. Correspondence to Iain B McInnes; iain.mcinnes{at}glasgow.ac.uk

Abstract

Objective This post hoc analysis of the phase III Active PSoriaTic Arthritis RAndomizEd TriAl (ASTRAEA) evaluated the effect of baseline body mass index (BMI) on subsequent response to subcutaneous (SC) abatacept in patients with psoriatic arthritis (PsA).

Methods In ASTRAEA, patients with active PsA were randomised (1:1) to receive blinded weekly SC abatacept 125 mg or placebo for 24 weeks. Treatment response at week 24 was assessed by the proportions of patients achieving American College of Rheumatology 20% improvement response, Disease Activity Score in 28 joints (DAS28 (C reactive protein (CRP))) ≤3.6 and <2.6, Health Assessment Questionnaire-Disability Index reduction from baseline ≥0.35 and radiographic non-progression (defined as change from baseline ≤0 in PsA-modified total Sharp/van der Heijde score). Responses were stratified by baseline BMI (underweight/normal, <25 kg/m2; overweight, 25–30 kg/m2; obese, >30 kg/m2) and compared in univariate and multivariate models.

Results Of 212/213 and 210/211 patients with baseline BMI data in the abatacept and placebo groups, respectively, 15% and 19% were underweight/normal, 36% and 27% were overweight, and 49% and 54% were obese. After adjusting for baseline characteristics, there were no significant differences for any outcome measure at week 24 with abatacept in the overweight or obese versus underweight/normal subgroup. In the placebo group, patients in the obese versus underweight/normal subgroup were significantly less likely to achieve DAS28 (CRP) <2.6 at week 24 (OR 0.26; 95% CI 0.08 to 0.87; p=0.03).

Conclusion BMI does not impact clinical or radiographic response to SC abatacept in patients with PsA.

Trial registration number NCT01860976.

  • DMARDs (biologic)
  • psoriatic arthritis
  • disease activity

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Footnotes

  • Contributors All authors contributed to the study conception and design, and interpretation of data. PJM and HAA contributed to the acquisition of data. All authors contributed to drafting the article or revising it critically for important intellectual content. All authors approved the version of the article to be published.

  • Funding This study was sponsored by the Bristol-Myers Squibb.

  • Competing interests IBM has received grant/research support from Bristol-Myers Squibb, Celgene, Janssen and UCB, and has acted as a consultant to Bristol-Myers Squibb (<US$10 000), AbbVie (<US$10 000), Celgene (<US$10 000), Janssen (<US$10 000), Lilly (<US$10 000), Novartis (<US$10 000), Pfizer (<US$10 000) and UCB (<US$10 000). GF has received grant/research support from Roche, Bristol-Myers Squibb and Pfizer, and has received speaking fees from MSD (<US$10 000), UCB (<US$10 000), Pfizer (<US$10 000), AbbVie (<US$10 000), Lilly (<US$10 000), Celgene (<US$10 000), Novartis (<US$10 000) and Roche (<US$10 000). MAD has received speaking fees from Bristol-Myers Squibb (<US$10 000), AbbVie (<US$10 000), Novartis (<US$10 000) and Celgene (<US$10 000). MLB was a shareholder and employee/consultant of Bristol-Myers Squibb (<US$10 000) at the time the study was conducted. SB and HAA are shareholders and employees/consultants of Bristol-Myers Squibb (<US$10 000). YE is a consultant to Bristol-Myers Squibb (<US$10 000). PJM received grant/research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun and UCB; acted as a consultant to AbbVie (>US$10 000), Amgen (>US$10 000), Bristol-Myers Squibb (<US$10 000), Celgene (<US$10 000), Corrona (<US$10 000), Galapagos (<US$10 000), Janssen (>US$10 000), Lilly (>US$10 000), Novartis (>US$10 000), Pfizer (>US$10 000), Sun (<US$10 000), UCB (<US$10 000) and Zynerba (<US$10 000); and received speaking fees from AbbVie (>US$10 000), Amgen (>US$10 000), Bristol-Myers Squibb (<US$10 000), Celgene (<US$10 000), Genentech (<US$10 000), Janssen (>US$10 000), Novartis (>US$10 000), Pfizer (>US$10 000) and UCB (<US$10 000).

  • Patient consent for publication Not required.

  • Ethics approval The ASTRAEA study was conducted in accordance with the Declaration of Helsinki and was consistent with the International Conference on Harmonisation and Good Clinical Practice. The study protocol, patient informed consent form and any other written materials supplied to the patient received ethics approval from the Schulman Associates Institutional Review Board (SAIRB). IRB organization number: 0000635; IRB registration number: 00000971. SAIRB did not provide approval numbers for each site.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request.

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