Two-year clinical outcomes after discontinuation of long-term golimumab therapy in Korean patients with rheumatoid arthritis
0
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Background/Aims: The aim of this study was to investigate long-term post-discontinuation outcomes in patients with rheumatoid arthritis (RA) who had been treated with tumor necrosis factor-α inhibitors (TNF-αi) which was then discontinued. Methods: Sixty Korean patients with RA who participated in a 5-year GO-BEFORE and GO-FORWARD extension trials were included in this retrospective study. Golimumab was deliberately discontinued after the extension study (baseline). Patients were then followed by their rheumatologists. We reviewed their medical records for 2 years (max 28 months) following golimumab discontinuation. Patients were divided into a maintained benefit (MB) group and a loss-of-benefit (LB) group based on treatment pattern after golimumab discontinuation. The LB group included patients whose conventional disease-modifying antirheumatic drug(s) were stepped-up or added/switched (SC) and those who restarted biologic therapy (RB). Results: The mean age of patients at baseline was 56.5 years and 55 (91.7%) were females. At the end of follow-up, 23 (38.3%) patients remained in the MB group. In the LB group, 75.7% and 24.3% were assigned into SC and RB subgroups, respectively. Fifty percent of patients lost MB after 23.3 months. Demographics and clinical variables at baseline were comparable between MB and LB groups except for age, C-reactive protein level, and corticosteroid use. Restarting biologic therapy was associated with swollen joint count (adjusted hazard ratio [HR], 1.90; 95% confidence interval [CI], 1.01 to 3.55) and disease duration (adjusted HR, 1.12; 95% CI, 1.02 to 1.23) at baseline. Conclusions: Treatment strategies after discontinuing TNF-αi are needed to better maintain disease control and quality of life of patients with RA.
Abstract
Background/Aims: The aim of this study was to investigate long-term post-discontinuation outcomes in patients with rheumatoid arthritis (RA) who had been treated with tumor necrosis factor-α inhibitors (TNF-αi) which was then discontinued. Methods: Sixty Korean patients with RA who participated in a 5-year GO-BEFORE and GO-FORWARD extension trials were included in this retrospective study. Golimumab was deliberately discontinued after the extension study (baseline). Patients were then followed by their rheumatologists. We reviewed their medical records for 2 years (max 28 months) following golimumab discontinuation. Patients were divided into a maintained benefit (MB) group and a loss-of-benefit (LB) group based on treatment pattern after golimumab discontinuation. The LB group included patients whose conventional disease-modifying antirheumatic drug(s) were stepped-up or added/switched (SC) and those who restarted biologic therapy (RB). Results: The mean age of patients at baseline was 56.5 years and 55 (91.7%) were females. At the end of follow-up, 23 (38.3%) patients remained in the MB group. In the LB group, 75.7% and 24.3% were assigned into SC and RB subgroups, respectively. Fifty percent of patients lost MB after 23.3 months. Demographics and clinical variables at baseline were comparable between MB and LB groups except for age, C-reactive protein level, and corticosteroid use. Restarting biologic therapy was associated with swollen joint count (adjusted hazard ratio [HR], 1.90; 95% confidence interval [CI], 1.01 to 3.55) and disease duration (adjusted HR, 1.12; 95% CI, 1.02 to 1.23) at baseline. Conclusions: Treatment strategies after discontinuing TNF-αi are needed to better maintain disease control and quality of life of patients with RA.
참고문헌 (28)
- Curtis JR, "Use of biologics in rheumatoid arthritis : current and emerging paradigms of care", Clin Ther, 33, pp.679~707 (2011)
- Upchurch KS, "Evolution of treatment for rheumatoid arthritis", Rheumatology (Oxford), 51(Suppl 6), pp.vi28~vi36 (2012)
- Bongartz T, "Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies : systematic review and meta-analysis of rare harmful effects in randomized controlled trials", JAMA, 295, pp.2275~2285 (2006)
- van Vollenhoven RF, "Treatment of rheumatoid arthritis : state of the art 2009", Nat Rev Rheumatol, 5, pp.531~541 (2009)
- Singh JA, "2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis", Arthritis Care Res(Hoboken), 68, pp.1~25 (2016)
- Kavanaugh A, "Discontinuation of tumour necrosis factor inhibitors in patients with rheumatoid arthritis in low-disease activity : persistent benefits. Data from the Corrona registry", Ann Rheum Dis, 74, pp.1150~1155 (2015)
- Tanaka Y, "Discontinuation of adalimumab after achieving remission in patients with established rheumatoid arthritis : 1-year outcome of the HONOR study", Ann Rheum Dis, 74, pp.389~395 (2015)
- van der Maas A, "Down-titration and discontinuation of infliximab in rheumatoid arthritis patients with stable low disease activity and stable treatment : an observational cohort study", Ann Rheum Dis, 71, pp.1849~1854 (2012)
- Tanaka Y, "Discontinuation of infliximab after attaining low disease activity in patients with rheumatoid arthritis : RRR(remission induction by Remicade in RA)study", Ann Rheum Dis, 69, pp.1286~1291 (2010)
- Smolen JS, "Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis(PRESERVE) : a randomised controlled trial", Lancet, 381, pp.918~929 (2013)
- Smolen JS, "Adjustment of therapy in rheumatoid arthritis on the basis of achievement of stable low disease activity with adalimumab plus methotrexate or methotrexate alone : the randomized controlled OPTIMA trial", Lancet, 383, pp.321~332 (2014)
- Emery P, "Sustained remission with etanercept tapering in early rheumatoid arthritis", N Engl J Med, 371, pp.1781~1792 (2014)
- Smolen JS, "Certolizumab pegol in rheumatoid arthritis patients with low to moderate activity : the CERTAIN double-blind, randomised, placebo-controlled trial", Ann Rheum Dis, 74, pp.843~850 (2015)
- Detert J, "Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naive patients with early rheumatoid arthritis : HIT HARD, an investigator-initiated study", Ann Rheum Dis, 72, pp.844~850 (2013)
- Allaart CF, "The BeSt way of withdrawing biologic agents", Clin Exp Rheumatol, 31(4 Suppl 78), pp.S14~S18 (2013)
- Haschka J, "Relapse rates in patients with rheumatoid arthritis in stable remission tapering or stopping antirheumatic therapy : interim results from the prospective randomised controlled RETRO study", Ann Rheum Dis, 75, pp.45~51 (2016)
- Shealy DJ, "Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor α", MAbs, 2, pp.428~439 (2010)
- Emery P, "Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naïve patients with active rheumatoid arthritis : twentyfour-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis", Arthritis Rheum, 60, pp.2272~2283 (2009)
- Keystone E, "Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy : 52-week results of the GO-FORWARD study", Ann Rheum Dis, 69, pp.1129~1135 (2010)
- Saleem B, "Patients with RA in remission on TNF blockers : when and in whom can TNF blocker therapy be stopped?", Ann Rheum Dis, 69, pp.1636~1642 (2010)
- Harigai M, "Discontinuation of adalimumab treatment in rheumatoid arthritis patients after achieving low disease activity", Mod Rheumatol, 22, pp.814~822 (2012)
- Brocq O, "Effect of discontinuing TNFalpha antagonist therapy in patients with remission of rheumatoid arthritis", Joint Bone Spine, 76, pp.350~355 (2009)
- Fautrel B, "Step-down strategy of spacing TNF-blocker injections for established rheumatoid arthritis in remission : results of the multicentre non-inferiority randomised open-label controlled trial(STRASS : Spacing of TNF-blocker injections in Rheumatoid ArthritiS Study)", Ann Rheum Dis, 75, pp.59~67 (2016)
- Tanaka Y, "The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis", Arthritis Res Ther, 21, pp.164~ (2019)
- Smolen JS, "EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs : 2019 update", Ann Rheum Dis, 79, pp.685~699 (2020)
- Pope J, "An open-label randomized controlled trial of DMARD withdrawal in RA patients achieving therapeutic response with certolizumab pegol combined with DMARDs", Rheumatology(Oxford), 59, pp.1522~1528 (2020)
- Pablos JL, "Efficacy of tocilizumab monotherapy after response to combined tocilizumab and methotrexate in patients with rheumatoid arthritis : the randomised JUST-ACT study", Clin Exp Rheumatol, 37, pp.437~444 (2019)
- van Mulligen E, "Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis : first-year results of the randomised controlled TARA study", Ann Rheum Dis, 78, pp.746~753 (2019)
