Journals / Turkish Journal of Medical Sciences / 2021 / Cilt: 51 - Sayı: 1

Efficacy, retention, and safety of tofacitinib in real-life: Hur-bio monocentric experience

Pages
297–308
Publication Date
2022-11-06
DOI
—
🏛️Bibliographic metadata and full text access for this article are provided via DergiPark.
DergiPark Record ↗
✨

AI Summary & Key Takeaways

AI Insight
⚡ TL;DR(Too Long; Didn't Read)

At 1 year, the overall tofacitinib retention rate was 63.9% with no relevant predicting factor.

📌 3 Key Takeaways

🎯
Objective & Hypothesis:Background/aim: To assess the real-life efficacy, retention rate, and safety data of tofacitinib in rheumatoid arthritis (RA) patients.
📊
Key Findings & Data:Materials and methods: We analyzed all patients registered in the HURBİO database who received at least 1 dose of tofacitinib.
💡
Conclusion & Impact:At 1 year, the overall tofacitinib retention rate was 63.9% with no relevant predicting factor.
🔬Design:Modeling & Simulation
📍Scope:Comprehensive Sample
⚙️Variables:Domain Parameters

Abstract

Background/aim: To assess the real-life efficacy, retention rate, and safety data of tofacitinib in rheumatoid arthritis (RA) patients. Materials and methods: We analyzed all patients registered in the HURBİO database who received at least 1 dose of tofacitinib. Patients who received at least one dose were included in retention analysis; patients with at least 1 control visit were included in efficacy and safety analysis. Factors predicting good response at the last follow-up visit were analyzed by logistic regression analysis. Drug retention rates were calculated using the Kaplan–Meier method and predictors of drug retention were determined by Cox proportional hazard model. Adverse events, reasons for switching, and discontinuation were also determined. Results: Two hundred and forty-seven (210, 85.0% female) patients were included in the study. The median duration of tofacitinib treatment was 10.2 (20.2) [med, (IQR)] months. Two hundred and four (82.6%) patients were included in safety and efficacy analysis; 45.6% of patients were in low-disease activity (LDA) state (DAS28-CRP ≤ 3.2). Predictors of LDA were being biologic-naïve [aOR 2.53 (1.31–4.88); 95% CI] and RF negativity [aOR 2.14 (1.12–4.07); 95% CI]. At 1 year, the overall tofacitinib retention rate was 63.9% with no relevant predicting factor. Response and retention rates of tofacitinib were similar in patients with and without concomitant csDMARDs. Treatment failure was the most common cause of discontinuation. The most common infectious and laboratory adverse events were herpes zoster infection (3.9 per 100 patient-years) and elevation in ALT (x3UNL: 9.7 per 100 patient-years), respectively. Conclusion: Tofacitinib is effective as monotherapy or in combination with csDMARDs. It is a well-tolerated treatment option in Turkish RA patients.Key words: Rheumatoid arthritis, tofacitinib, real-life, predictor

🔖

Cite This Article

KILIÇ, L., BİLGİN, E., AKDOĞAN, A., KALYONCU, U., KİRAZ, S., KARADAĞ, Ö., ERTENLİ, A. İ., YARDIMCI, G. K., DURAN, E., BÖLEK, E. Ç., CEYLAN, F., FARİSOĞULLARI, B., BİLGEN, Ş. A. (2022). Efficacy, retention, and safety of tofacitinib in real-life: Hur-bio monocentric experience. Turkish Journal of Medical Sciences, Cilt: 51 - Sayı: 1, 297–308. https://ajindex.com/articles/609407

📄 Full Text PDF Viewer

📄

PDF görüntüleyici hazırlanıyor...

References (9)

  1. Aletaha D, Smolen JS. Diagnosis and management of rheumatoid arthritis: a review. JAMA 2018
  2. 320 (13): 1360- 1372. doi: 10.1001/jama.2018.13103 2. Smolen JS, Landewe RBM, Bijlsma JWJ, Burmester GR, Dougados M et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Annals of the Rheumatic Diseases 2020
  3. 79 (6): 685- 699. doi: 10.1136/annrheumdis-2019-216655 3. Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y et al. (2004) Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis and Rheumatology 2004
  4. 50 (5): 1400-1411. doi: 10.1002/art.20217 4. Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C et al. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet 2013
  5. 381 (9865): 451-460. doi: 10.1016/S0140-6736(12)61424-X 5. Fleischmann R, Kremer J, Cush J, Schulze-Koops H, Connell CA et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. New England Journal of Medicine 2012
  6. 367 (6): 495-507. doi:10.1056/NEJMoa1109071 6. Kremer J, Li ZG, Hall S, Fleischmann R, Genovese M et al. Tofacitinib in combination with nonbiologic diseasemodifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomized trial. Annals of Internal Medicine 2013
  7. 159 (4): 253-261. doi:10.7326/0003-4819-159- 4-201308200-00006 7. Tanaka Y, Suzuki M, Nakamura H, Toyoizumi S, Zwillich SH et al. Phase II study of tofacitinib (CP-690,550) combined with methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate. Arthritis Care Research (Hoboken) 2011
  8. 63 (8): 1150-1158. doi: 10.1002/acr.20494 8. Van Vollenhoven RF, Fleischmann R, Cohen S, Lee EB, Garcia Meijide JA et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. New England Journal of Medicine 2012
  9. 367 (6): 508-519. doi: 10.1056/NEJMoa1112072 9. Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D et al. Tofacitinib versus biologic treatments in patients with active rheumatoid arthritis who have had an inadequate response to tumor necrosis f