Smoking and pre-existing organ damage reduce the efficacy of belimumab in systemic lupus erythematosus

Research output: Contribution to journalArticle


Objectives Belimumab is the first biologic drug approved for Systemic Lupus Erythematosus (SLE). Here, we aimed to investigate the effects of belimumab on clinical and serologic outcomes, and sought to identify predictors of treatment response in three Swedish real-life settings. Methods Fifty-eight patients were enrolled at initiation of belimumab and followed longitudinally for up to 53 months. Surveillance outcomes included the SLE Disease Activity Index 2000 (SLEDAI-2K), 100 mm Visual Analogue Scales for Physician's Global Assessment (PGA), fatigue, pain and general health, and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Assessment of treatment response included the SLE responder index (SRI). B lymphocyte stimulator (BLyS) levels were determined using ELISA. Results SLEDAI-2K (median baseline score: 8.0; IQR: 4.0–13.8), PGA and corticosteroid use decreased during therapy, and patients reported improvements on fatigue, pain, and general health (p < 0.0001 for all). SDI scores remained stable (p = 0.08). Patients with baseline SDI scores > 1 showed decreased probability and prolonged time to attain SRI response (HR: 0.449; 95% CI: 0.208–0.967), as did current smokers compared with non-smokers (HR: 0.103; 95% CI: 0.025–0.427). In contrast, baseline BLyS levels ≥ 1.2 ng/mL predicted increased probability and shorter time to attain SRI response (HR: 2.566; 95% CI: 1.222–5.387). Conclusions Disease activity and corticosteroid usage decreased, patient-reported outcomes improved, and no significant organ damage was accrued during follow-up. Smoking and organ damage predicted reduced treatment efficacy. These findings might contribute to a better selection of patients who are likely to benefit from belimumab.


  • Ioannis Parodis
  • Christopher Sjöwall
  • Andreas Jönsen
  • Daniel Ramsköld
  • Agneta Zickert
  • Martina Frodlund
  • Azita Sohrabian
  • Laurent Arnaud
  • Johan Rönnelid
  • Vivianne Malmström
  • Anders A. Bengtsson
  • Iva Gunnarsson
External organisations
  • Karolinska University Hospital
  • Uppsala University
  • University of Strasbourg
  • Linköping University
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Rheumatology and Autoimmunity


  • BAFF, Belimumab, Biologics, BLyS, Systemic lupus erythematosus
Original languageEnglish
Pages (from-to)343-351
Number of pages9
JournalAutoimmunity Reviews
Issue number4
Publication statusPublished - 2017 Apr 1
Publication categoryResearch