Randomized Controlled Trial of Hydroxychloroquine Combined With Low-dose Corticosteroid in Pulmonary Sarcoidosis

Summary

"The reference treatment for pulmonary sarcoidosis is prolonged systemic corticosteroid therapy, which improves dyspnea, fatigue and respiratory function. However, corticosteroid therapy doesn't improve quality of life, possibly due to its adverse effects. Furthermore, in an international survey study, the first priority in treatment outcome for sarcoidosis patient was quality of life. Hydroxychloroquine an antimalarial drug, has been shown to be effective in cutaneous and pulmonary forms of sarcoidosis but in studies with imperfect methodology. Our hypothesis is that hydroxychloroquine associated with low-dose corticosteroids improves lung function as much as ""conventional"" medium-dose corticosteroid therapy but with fewer side effects and a better quality of life in pulmonary sarcoidosis. "

Timeline

Start

2022-03-01

Primary completion

2023-03-01

Completion

2024-03-01

Publications

• Background Broos CE, Wapenaar M, Looman CWN, In 't Veen JCCM, van den Toorn LM, Overbeek MJ, Grootenboers MJJH, Heller R, Mostard RL, Poell LHC, Hoogsteden HC, Kool M, Wijsenbeek MS, van den Blink B. Daily home spirometry to detect early steroid treatment effects in newly treated pulmonary sarcoidosis. Eur Respir J. 2018 Jan 18;51(1):1702089. doi: 10.1183/13993003.02089-2017. Print 2018 Jan. No abstract available.
• Background Crouser ED, Maier LA, Wilson KC, Bonham CA, Morgenthau AS, Patterson KC, Abston E, Bernstein RC, Blankstein R, Chen ES, Culver DA, Drake W, Drent M, Gerke AK, Ghobrial M, Govender P, Hamzeh N, James WE, Judson MA, Kellermeyer L, Knight S, Koth LL, Poletti V, Raman SV, Tukey MH, Westney GE, Baughman RP. Diagnosis and Detection of Sarcoidosis. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Apr 15;201(8):e26-e51. doi: 10.1164/rccm.202002-0251ST.
• Background Khan NA, Donatelli CV, Tonelli AR, Wiesen J, Ribeiro Neto ML, Sahoo D, Culver DA. Toxicity risk from glucocorticoids in sarcoidosis patients. Respir Med. 2017 Nov;132:9-14. doi: 10.1016/j.rmed.2017.09.003. Epub 2017 Sep 8.
• Background Baughman RP, Barriuso R, Beyer K, Boyd J, Hochreiter J, Knoet C, Martone F, Quadder B, Richardson J, Spitzer G, Valeyre D, Ziosi G. Sarcoidosis: patient treatment priorities. ERJ Open Res. 2018 Dec 21;4(4):00141-2018. doi: 10.1183/23120541.00141-2018. eCollection 2018 Oct.
• Background Ponticelli C, Moroni G. Hydroxychloroquine in systemic lupus erythematosus (SLE). Expert Opin Drug Saf. 2017 Mar;16(3):411-419. doi: 10.1080/14740338.2017.1269168. Epub 2016 Dec 14.
• Background Baltzan M, Mehta S, Kirkham TH, Cosio MG. Randomized trial of prolonged chloroquine therapy in advanced pulmonary sarcoidosis. Am J Respir Crit Care Med. 1999 Jul;160(1):192-7. doi: 10.1164/ajrccm.160.1.9809024.
• Background Judson MA, Baughman RP, Costabel U, Flavin S, Lo KH, Kavuru MS, Drent M; Centocor T48 Sarcoidosis Investigators. Efficacy of infliximab in extrapulmonary sarcoidosis: results from a randomised trial. Eur Respir J. 2008 Jun;31(6):1189-96. doi: 10.1183/09031936.00051907. Epub 2008 Feb 6.

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