The Korean journal of internal medicine

The Korean Association of Internal Medicine (대한내과학회)
권호 표지
DOI QR코드

DOI QR Code

Drug survival and the associated predictors in South Korean patients with rheumatoid arthritis receiving tacrolimus

  • Park, Eun-Young (Division of Rheumatology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine) ;
  • Lee, Seung-Geun (Division of Rheumatology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine) ;
  • Park, Eun-Kyoung (Division of Rheumatology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine) ;
  • Koo, Dong-Wan (Division of Rheumatology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine) ;
  • Park, Ji-Heh (Division of Rheumatology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine) ;
  • Kim, Geun-Tae (Division of Rheumatology, Department of Internal Medicine, Kosin University College of Medicine) ;
  • Tag, Hee-Sang (Division of Rheumatology, Department of Internal Medicine, Kosin University College of Medicine) ;
  • Kim, Hyun-Ok (Division of Rheumatology, Department of Internal Medicine, Gyeongsang National University School of Medicine) ;
  • Suh, Young-Sun (Division of Rheumatology, Department of Internal Medicine, Gyeongsang National University School of Medicine)
  • Received : 2015.11.29
  • Accepted : 2015.12.28
  • Published : 2018.01.01
⟨ Previous Next ⟩

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.

Keywords

Acknowledgement

Supported by : Pusan National University Hospital

References

  1. Greenberg JD, Reed G, Decktor D, et al. 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 2012;71:1134-1142. https://doi.org/10.1136/annrheumdis-2011-150573
  2. Neovius M, Arkema EV, Olsson H, et al. Drug survival on TNF inhibitors in patients with rheumatoid arthritis comparison of adalimumab, etanercept and infliximab. Ann Rheum Dis 2015;74:354-360. https://doi.org/10.1136/annrheumdis-2013-204128
  3. Marchesoni A, Zaccara E, Gorla R, et al. TNF-alpha antagonist survival rate in a cohort of rheumatoid arthritis patients observed under conditions of standard clinical practice. Ann N Y Acad Sci 2009;1173:837-846. https://doi.org/10.1111/j.1749-6632.2009.04621.x
  4. Du Pan SM, Dehler S, Ciurea A, et al. Comparison of drug retention rates and causes of drug discontinuation between anti-tumor necrosis factor agents in rheumatoid arthritis. Arthritis Rheum 2009;61:560-568. https://doi.org/10.1002/art.24463
  5. Hetland ML, Christensen IJ, Tarp U, et al. 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 2010;62:22-32. https://doi.org/10.1002/art.27227
  6. Kievit W, Fransen J, Adang EM, et al. Long-term effectiveness and safety of TNF-blocking agents in daily clinical practice: results from the Dutch Rheumatoid Arthritis Monitoring register. Rheumatology (Oxford) 2011;50:196-203. https://doi.org/10.1093/rheumatology/keq325
  7. Gomez-Reino JJ, Rodriguez-Lozano C, Campos-Fernandez C, et al. 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 2012;71:382-385. https://doi.org/10.1136/annrheumdis-2011-200302
  8. Markatseli TE, Alamanos Y, Saougou I, Voulgari PV, Drosos AA. Survival of TNF-alpha antagonists in rheumatoid arthritis: a long-term study. Clin Exp Rheumatol 2012;30:31-38.
  9. Sakai R, Tanaka M, Nanki T, et al. 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 2012;71:1820-1826. https://doi.org/10.1136/annrheumdis-2011-200838
  10. Yang CT, Kuo CF, Luo SF, Yu KH. Discontinuation of anti-TNF-$\alpha$ therapy in a Chinese cohort of patients with rheumatoid arthritis. Clin Rheumatol 2012;31:1549-1557. https://doi.org/10.1007/s10067-012-2047-8
  11. Scire CA, Caporali R, Sarzi-Puttini P, et al. 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 2013;31:857-863.
  12. Biggioggero M, Favalli EG. Ten-year drug survival of anti-TNF agents in the treatment of inflammatory arthritides. Drug Dev Res 2014;75 Suppl 1:S38-S41. https://doi.org/10.1002/ddr.21192
  13. Hirabara S, Takahashi N, Fukaya N, et al. Clinical efficacy of abatacept, tocilizumab, and etanercept in Japanese rheumatoid arthritis patients with inadequate response to anti-TNF monoclonal antibodies. Clin Rheumatol 2014;33:1247-1254. https://doi.org/10.1007/s10067-014-2711-2
  14. Kang JH, Park DJ, Lee JW, et al. Drug survival rates of tumor necrosis factor inhibitors in patients with rheumatoid arthritis and ankylosing spondylitis. J Korean Med Sci 2014;29:1205-1211. https://doi.org/10.3346/jkms.2014.29.9.1205
  15. Frazier-Mironer A, Dougados M, Mariette X, et al. Retention rates of adalimumab, etanercept and infliximab as first and second-line biotherapy in patients with rheumatoid arthritis in daily practice. Joint Bone Spine 2014;81:352-359. https://doi.org/10.1016/j.jbspin.2014.02.014
  16. Forsblad-d'Elia H, Bengtsson K, Kristensen LE, Jacobsson LT. Drug adherence, response and predictors thereof for tocilizumab in patients with rheumatoid arthritis: results from the Swedish biologics register. Rheumatology (Oxford) 2015;54:1186-1193. https://doi.org/10.1093/rheumatology/keu455
  17. Bettembourg-Brault I, Gossec L, Pham T, Gottenberg JE, Damiano J, Dougados M. Leflunomide in rheumatoid arthritis in daily practice: treatment discontinuation rates in comparison with other DMARDs. Clin Exp Rheumatol 2006;24:168-171.
  18. Jagoda JS, Rajapakse CN. Leflunomide in clinical practice: a retrospective observational study on use of leflunomide in New Zealand. Int J Rheum Dis 2011;14:340-344. https://doi.org/10.1111/j.1756-185X.2011.01637.x
  19. Rodriguez-Rodriguez L, Jover-Jover JA, Fontsere O, et al. Leflunomide discontinuation in rheumatoid arthritis and influence of associated disease-modifying antirheumatic drugs: a survival analysis. Scand J Rheumatol 2013;42:433-436. https://doi.org/10.3109/03009742.2013.785590
  20. Aletaha D, Stamm T, Kapral T, et al. Survival and effectiveness of leflunomide compared with methotrexate and sulfasalazine in rheumatoid arthritis: a matched observational study. Ann Rheum Dis 2003;62:944-951. https://doi.org/10.1136/ard.62.10.944
  21. Dutta S, Ahmad Y. The efficacy and safety of tacrolimus in rheumatoid arthritis. Ther Adv Musculoskelet Dis 2011;3:283-291. https://doi.org/10.1177/1759720X11419038
  22. Furst DE, Saag K, Fleischmann MR, et al. 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 2002;46:2020-2028. https://doi.org/10.1002/art.10427
  23. Yocum DE, Furst DE, Kaine JL, et al. Efficacy and safety of tacrolimus in patients with rheumatoid arthritis: a double-blind trial. Arthritis Rheum 2003;48:3328-3337. https://doi.org/10.1002/art.11363
  24. Kondo H, Abe T, Hashimoto H, et al. Efficacy and safety of tacrolimus (FK506) in treatment of rheumatoid arthritis: a randomized, double blind, placebo controlled dosefinding study. J Rheumatol 2004;31:243-251.
  25. Kawai S, Takeuchi T, Yamamoto K, Tanaka Y, Miyasaka N. 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 2011;21:458-468. https://doi.org/10.3109/s10165-011-0425-8
  26. Lee YH, Woo JH, Choi SJ, Ji JD, Bae SC, Song GG. Tacrolimus for the treatment of active rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials. Scand J Rheumatol 2010;39:271-278. https://doi.org/10.3109/03009740903501642
  27. Kitahama M, Okamoto H, Koseki Y, et al. Efficacy and safety of tacrolimus in 101 consecutive patients with rheumatoid arthritis. Mod Rheumatol 2010;20:478-485. https://doi.org/10.3109/s10165-010-0319-1
  28. Ogasawara M, Tamura N, Kageyama M, et al. 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 2012;31:251-257. https://doi.org/10.1007/s10067-011-1810-6
  29. Kanzaki T, Kawahata K, Kanda H, et al. Long-term therapeutic effects and safety of tacrolimus added to methotrexate in patients with rheumatoid arthritis. Rheumatol Int 2013;33:871-877. https://doi.org/10.1007/s00296-012-2465-6
  30. Motomura H, Matsushita I, Seki E, Mine H, Kimura T. Inhibitory effect of tacrolimus on progression of joint damage in patients with rheumatoid arthritis. Int J Rheum Dis 2014;17:749-754. https://doi.org/10.1111/1756-185X.12227
  31. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-324. https://doi.org/10.1002/art.1780310302
  32. Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. 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 1995;38:44-48. https://doi.org/10.1002/art.1780380107
  33. van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum 1998;41:1845-1850. https://doi.org/10.1002/1529-0131(199810)41:10<1845::AID-ART17>3.0.CO;2-K
  34. Yazici Y, Krasnokutsky S, Barnes JP, Hines PL, Wang J, Rosenblatt L. Changing patterns of tumor necrosis factor inhibitor use in 9074 patients with rheumatoid arthritis. J Rheumatol 2009;36:907-913. https://doi.org/10.3899/jrheum.080592
  35. Gutsche M, Rosen GD, Swigris JJ. Connective tissue disease-associated interstitial lung disease: a review. Curr Respir Care Rep 2012;1:224-232. https://doi.org/10.1007/s13665-012-0028-7
  36. Kobayashi A, Okamoto H. Treatment of interstitial lung diseases associated with connective tissue diseases. Expert Rev Clin Pharmacol 2012;5:219-227. https://doi.org/10.1586/ecp.12.9
  37. Koike R, Tanaka M, Komano Y, et al. Tacrolimus-induced pulmonary injury in rheumatoid arthritis patients. Pulm Pharmacol Ther 2011;24:401-406. https://doi.org/10.1016/j.pupt.2011.01.016
  38. Takeuchi T, Kawai S, Yamamoto K, Harigai M, Ishida K, Miyasaka N. Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis. Mod Rheumatol 2014;24:8-16. https://doi.org/10.3109/14397595.2013.854074

Cited by

  1. Neutropenia in the Elderly: A Rheumatology Perspective vol.33, pp.8, 2016, https://doi.org/10.1007/s40266-016-0383-0
  2. Manipulating the expression of SARP family regulator BulZ and its target gene product to increase tacrolimus production vol.102, pp.11, 2018, https://doi.org/10.1007/s00253-018-8979-4
  3. Neutrophil-to-lymphocyte and platelet-to-lymphocyte ratio as predictors of 12-week treatment response and drug persistence of anti-tumor necrosis factor-α agents in patients with rheumatoid arth vol.39, pp.5, 2018, https://doi.org/10.1007/s00296-019-04276-x
  4. The Impact of the Amendment of the Korean National Health Insurance Reimbursement Criteria for Anti-tumor Necrosis Factor-α Agents on Treatment Pattern, Clinical Response and Persistence in Pati vol.27, pp.3, 2020, https://doi.org/10.4078/jrd.2020.27.3.159
  5. Effects of overweight and underweight on the treatment outcomes of rheumatoid arthritis patients treated with biological drugs: A retrospective observational descriptive study vol.45, pp.4, 2020, https://doi.org/10.1111/jcpt.13136
  6. Safety of Tacrolimus in Autoimmune Disease: Results From Post-marketing Surveillance in South Korea vol.28, pp.4, 2018, https://doi.org/10.4078/jrd.2021.28.4.202