Drug survival and the associated predictors in South Korean patients with rheumatoid arthritis receiving tacrolimus
1
조회
0
다운로드
2
인용
0
참고문헌
키워드
초록
Background/Aims: To investigate the drug survival rate of tacrolimus (TAC) and analyze the potential predictors of this rate in patients with rheumatoid arthritis (RA) in routine care. Methods: In this retrospective longitudinal study, we enrolled 102 RA patients treated with TAC from April 2009 to January 2014 at a tertiary center in South Korea. The causes of TAC discontinuation were classified as lack of efficacy (LOE), adverse events (AEs), and others. The drug survival rate was estimated using the Kaplan-Meier method and the predictors of this rate were identified by Coxregression analyses. Results: TAC was discontinued in 27 of 102 RA patients (26.5%). The overall 1-, 2-, 3-, and 4-year TAC continuation rates were 81.8%, 78.4%, 74.2%, and 69.1%, respectively and the median follow-up period from the start of TAC was 32.5 months. The number of TAC discontinuations due to LOE, AEs, and others were 15 (55.6%), 11 (40.7 %), and 1 (3.7%), respectively. The baseline high disease activity was a significant risk factor for TAC discontinuation after adjusting for confounding factors (hazard ratio [HR], 2.49; 95% confidence interval [CI], 1.16 to 5.35; p = 0.019). In addition, underlying interstitial lung disease was significantly associated with TAC withdrawal due to AEs (HR, 3.49; 95% CI, 1.06 to 11.46; p = 0.039). Conclusions: In our study, TAC showed a good overall survival rate in patients with RA in real clinical practice. This suggests that the long-term TAC therapy has a favorable efficacy and safety profile for treating RA.
Abstract
Background/Aims: To investigate the drug survival rate of tacrolimus (TAC) and analyze the potential predictors of this rate in patients with rheumatoid arthritis (RA) in routine care. Methods: In this retrospective longitudinal study, we enrolled 102 RA patients treated with TAC from April 2009 to January 2014 at a tertiary center in South Korea. The causes of TAC discontinuation were classified as lack of efficacy (LOE), adverse events (AEs), and others. The drug survival rate was estimated using the Kaplan-Meier method and the predictors of this rate were identified by Coxregression analyses. Results: TAC was discontinued in 27 of 102 RA patients (26.5%). The overall 1-, 2-, 3-, and 4-year TAC continuation rates were 81.8%, 78.4%, 74.2%, and 69.1%, respectively and the median follow-up period from the start of TAC was 32.5 months. The number of TAC discontinuations due to LOE, AEs, and others were 15 (55.6%), 11 (40.7 %), and 1 (3.7%), respectively. The baseline high disease activity was a significant risk factor for TAC discontinuation after adjusting for confounding factors (hazard ratio [HR], 2.49; 95% confidence interval [CI], 1.16 to 5.35; p = 0.019). In addition, underlying interstitial lung disease was significantly associated with TAC withdrawal due to AEs (HR, 3.49; 95% CI, 1.06 to 11.46; p = 0.039). Conclusions: In our study, TAC showed a good overall survival rate in patients with RA in real clinical practice. This suggests that the long-term TAC therapy has a favorable efficacy and safety profile for treating RA.
참고문헌 (38)
- Greenberg JD, "A comparative effectiveness study of adalimumab, etanercept and infliximab in biologically naive and switched rheumatoid arthritis patients: results from the US CORRONA registry", Ann Rheum Dis, 71, pp.1134~1142 (2012)[DOI]
- Neovius M, "Drug survival on TNF inhibitors in patients with rheumatoid arthritis comparison of adalimumab, etanercept and infliximab", Ann Rheum Dis, 74, pp.354~360 (2015)[DOI]
- Marchesoni A, "TNF-alpha antagonist survival rate in a cohort of rheumatoid arthritis patients observed under conditions of standard clinical practice", Ann N Y Acad Sci, 1173, pp.837~846 (2009)[DOI]
- Du Pan SM, "Comparison of drug retention rates and causes of drug discontinuation between anti-tumor necrosis factor agents in rheumatoid arthritis", Arthritis Rheum, 61, pp.560~568 (2009)[DOI]
- Hetland ML, "Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry", Arthritis Rheum, 62, pp.22~32 (2010)[DOI]
- Kievit W, "Long-term effectiveness and safety of TNF-blocking agents in daily clinical practice: results from the Dutch Rheumatoid Arthritis Monitoring register", Rheumatology (Oxford), 50, pp.196~203 (2011)[DOI]
- Gomez-Reino JJ, "Change in the discontinuation pattern of tumour necrosis factor antagonists in rheumatoid arthritis over 10 years: data from the Spanish registry BIOBADASER 2.0", Ann Rheum Dis, 71, pp.382~385 (2012)[DOI]
- Markatseli TE, "Survival of TNF-alpha antagonists in rheumatoid arthritis: a long-term study", Clin Exp Rheumatol, 30, pp.31~38 (2012)
- Sakai R, "Drug retention rates and relevant risk factors for drug discontinuation due to adverse events in rheumatoid arthritis patients receiving anticytokine therapy with different target molecules", Ann Rheum Dis, 71, pp.1820~1826 (2012)[DOI]
- Yang CT, "Discontinuation of anti-TNF-<TEX>$\alpha$<", TEX> therapy in a Chinese cohort of patients with rheumatoid arthritis, 2012, pp.31, 1549~1557
- Scire CA, "Drug survival of the first course of anti-TNF agents in patients with rheumatoid arthritis and seronegative spondyloarthritis: analysis from the MonitorNet database", Clin Exp Rheumatol, 31, pp.857~863 (2013)
- Biggioggero M, "Ten-year drug survival of anti-TNF agents in the treatment of inflammatory arthritides", Drug Dev Res, 75(Suppl 1), pp.S38~S41 (2014)[DOI]
- Hirabara S, "Clinical efficacy of abatacept, tocilizumab, and etanercept in Japanese rheumatoid arthritis patients with inadequate response to anti-TNF monoclonal antibodies", Clin Rheumatol, 33, pp.1247~1254 (2014)[DOI]
- 강지현, "Drug Survival Rates of Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis", Journal of Korean Medical Science, 29(9), pp.1205~1211 (2014), 대한의학회
- Frazier-Mironer A, "Retention rates of adalimumab, etanercept and infliximab as first and second-line biotherapy in patients with rheumatoid arthritis in daily practice", Joint Bone Spine, 81, pp.352~359 (2014)[DOI]
- Forsblad-d'Elia H, "Drug adherence, response and predictors thereof for tocilizumab in patients with rheumatoid arthritis: results from the Swedish biologics register", Rheumatology (Oxford), 54, pp.1186~1193 (2015)[DOI]
- Bettembourg-Brault I, "Leflunomide in rheumatoid arthritis in daily practice: treatment discontinuation rates in comparison with other DMARDs", Clin Exp Rheumatol, 24, pp.168~171 (2006)
- Jagoda JS, "Leflunomide in clinical practice: a retrospective observational study on use of leflunomide in New Zealand", Int J Rheum Dis, 14, pp.340~344 (2011)[DOI]
- Rodriguez-Rodriguez L, "Leflunomide discontinuation in rheumatoid arthritis and influence of associated disease-modifying antirheumatic drugs: a survival analysis", Scand J Rheumatol, 42, pp.433~436 (2013)[DOI]
- Aletaha D, "Survival and effectiveness of leflunomide compared with methotrexate and sulfasalazine in rheumatoid arthritis: a matched observational study", Ann Rheum Dis, 62, pp.944~951 (2003)[DOI]
- Dutta S, "The efficacy and safety of tacrolimus in rheumatoid arthritis", Ther Adv Musculoskelet Dis, 3, pp.283~291 (2011)[DOI]
- Furst DE, "Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with methotrexate: a six-month, double-blind, randomized, dose-ranging study", Arthritis Rheum, 46, pp.2020~2028 (2002)[DOI]
- Yocum DE, "Efficacy and safety of tacrolimus in patients with rheumatoid arthritis: a double-blind trial", Arthritis Rheum, 48, pp.3328~3337 (2003)[DOI]
- Kondo H, "Efficacy and safety of tacrolimus (FK506) in treatment of rheumatoid arthritis: a randomized, double blind, placebo controlled dosefinding study", J Rheumatol, 31, pp.243~251 (2004)
- Kawai S, "Efficacy and safety of additional use of tacrolimus in patients with early rheumatoid arthritis with inadequate response to DMARDs: a multicenter, double-blind, parallel-group trial", Mod Rheumatol, 21, pp.458~468 (2011)[DOI]
- Lee YH, "Tacrolimus for the treatment of active rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials", Scand J Rheumatol, 39, pp.271~278 (2010)[DOI]
- Kitahama M, "Efficacy and safety of tacrolimus in 101 consecutive patients with rheumatoid arthritis", Mod Rheumatol, 20, pp.478~485 (2010)[DOI]
- Ogasawara M, "Single-center, retrospective analysis of efficacy and safety of tacrolimus as a second-line DMARD in combination therapy and the risk factors contributing to adverse events in 115 patients with rheumatoid arthritis", Clin Rheumatol, 31, pp.251~257 (2012)[DOI]
- Kanzaki T, "Long-term therapeutic effects and safety of tacrolimus added to methotrexate in patients with rheumatoid arthritis", Rheumatol Int, 33, pp.871~877 (2013)[DOI]
- Motomura H, "Inhibitory effect of tacrolimus on progression of joint damage in patients with rheumatoid arthritis", Int J Rheum Dis, 17, pp.749~754 (2014)[DOI]
- Arnett FC, "The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis", Arthritis Rheum, 31, pp.315~324 (1988)[DOI]
- Prevoo ML, "Modified disease activity scores that include twenty-eight-joint counts: development and validation in a prospective longitudinal study of patients with rheumatoid arthritis", Arthritis Rheum, 38, pp.44~48 (1995)[DOI]
- van Gestel AM, "Validation of rheumatoid arthritis improvement criteria that include simplified joint counts", Arthritis Rheum, 41, pp.1845~1850 (1998)[DOI]
- Yazici Y, "Changing patterns of tumor necrosis factor inhibitor use in 9074 patients with rheumatoid arthritis", J Rheumatol, 36, pp.907~913 (2009)[DOI]
- Gutsche M, "Connective tissue disease-associated interstitial lung disease: a review", Curr Respir Care Rep, 1, pp.224~232 (2012)[DOI]
- Kobayashi A, "Treatment of interstitial lung diseases associated with connective tissue diseases", Expert Rev Clin Pharmacol, 5, pp.219~227 (2012)[DOI]
- Koike R, "Tacrolimus-induced pulmonary injury in rheumatoid arthritis patients", Pulm Pharmacol Ther, 24, pp.401~406 (2011)[DOI]
- Takeuchi T, "Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis", Mod Rheumatol, 24, pp.8~16 (2014)[DOI]
