Современная ревматология (Dec 2023)

Long-term effects of netakimab on health-related quality of life, back pain and work productivity in patients with ankylosing spondylitis: results of the international, multicentre, randomized double-blind phase III clinical trial BCD-085-5/ASTERA

  • T. V. Dubinina,
  • A. B. Demina,
  • E. M. Agafonova,
  • Sh. F. Erdes,
  • V. I. Mazurov,
  • I. Z. Gaydukova,
  • A. M. Pristrom,
  • E. V. Kunder,
  • N. F. Soroka,
  • A. A. Kastanayan,
  • T. V. Povarova,
  • E. S. Zhugrova,
  • T. V. Plaksina,
  • P. A. Shesternya,
  • T. V. Kropotina,
  • O. V. Antipova,
  • E. A. Smolyarchuk,
  • O. A. Tsyupa,
  • D. I. Abdulganieva,
  • S. A. Lapshina,
  • D. G. Krechikova,
  • I. G. Gordeev,
  • O. B. Nesmeyanova,
  • V. V. Tyrenko,
  • E. P. Ilivanova,
  • A. V. Strelkova

DOI
https://doi.org/10.14412/1996-7012-2023-6-52-58
Journal volume & issue
Vol. 17, no. 6
pp. 52 – 58

Abstract

Read online

The article contains the data obtained during the 156-week follow-up of patients with ankylosing spondylitis (AS) in the ASTERA phase III study.Objective: to evaluate the effect impact of netakimab (NTK) on quality of life (QoL), back pain and work capacity in patients with active AS.Material and methods. The study enrolled 228 patients with active AS who were randomized 1:1 to receive NTK 120 mg or placebo. At week 52, patients in Group 1 (NTK) who achieved ASAS20 continued therapy (NTK at a dose of 120 mg once every 2 weeks) until week 156. Patients in Group 2 (placebo/NTK) received the study drug at a dose of 120 mg subcutaneously every 2 weeks from week 20 until week 68, after which the efficacy of therapy was determined (by achieving an ASAS20 response). Patients who achieved ASAS20 received treatment (NTK at a dose of 120 mg once every 2 weeks) until week 172.Results and discussion. Under NTK therapy, a significant improvement in QoL was observed in the assessment of the physical and psychological components of the SF-36 questionnaire, which was maintained during the three years of therapy: increase in indicator by 12.68±9.92; 13.27±10.14; 12.92±10.03; 14.10±10.35; 14.76±9.77 and 6.10±11.59; 5.50±11.82; 6.32±11.01; 5.87±11.45; 5.25±11.98 points at week 52, 76, 104, 128 and 156, respectively. During the extended therapy period, a reduction in the proportion of working hours missed for health reasons, an improvement in work capacity and work efficiency and an increase in daily activity were observed. Back pain (BASDAI question 2) and nocturnal back pain decreased steadily during the entire follow-up period compared to the screening values.Conclusion. NTK is an effective therapy for active AS that improves QoL scores, significantly reduces pain intensity and improves work productivity.

Keywords