1. Risk of hydroxychloroquine alone and in combination with azithromycin in the treatment of rheumatoid arthritis: a multinational, retrospective study
- Author
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Lane, J.C.E., Weaver, J. (JoEllen), Kostka, K., Duarte-Salles, T., Abrahao, M.T.F., Alghoul, H., Alser, O., Alshammari, T.M., Biedermann, P., Banda, J.M., Burn, E., Casajust, P., Conover, M.M., Culhane, A.C., Davydov, A., DuVall, S.L., Dymshyts, D., Fernandez-Bertolin, S., Fister, K., Hardin, J., Hester, L., Hripcsak, G. (G.), Kaas-Hansen, B.S., Kent, S., Khosla, S., Kolovos, S., Lambert, C.G., Lei, J. (Johan) van der, Lynch, K.E., Makadia, R., Margulis, A.V., Matheny, M.E., Mehta, P., Morales, D.R., Morgan-Stewart, H., Mosseveld, M. (Mees), Newby, D., Nyberg, F. (Fredrik), Ostropolets, A., Park, RW, Prats-Uribe, A., Rao, G.A., Reich, C., Reps, J., Rijnbeek, P.R. (Peter), Sathappan, S.M.K., Schuemie, M.J. (Martijn), Seager, S., Sena, A.G., Shoaibi, A., Spotnitz, M., Suchard, M.A. (Marc), Torre, C.O., Vizcaya, D., Wen, H.N., Wilde, M. (Marcel) de, Xie, J.Q., You, S.C., Zhang, L., Zhuk, O., Ryan, P., Prieto-Alhambra, D., Lane, J.C.E., Weaver, J. (JoEllen), Kostka, K., Duarte-Salles, T., Abrahao, M.T.F., Alghoul, H., Alser, O., Alshammari, T.M., Biedermann, P., Banda, J.M., Burn, E., Casajust, P., Conover, M.M., Culhane, A.C., Davydov, A., DuVall, S.L., Dymshyts, D., Fernandez-Bertolin, S., Fister, K., Hardin, J., Hester, L., Hripcsak, G. (G.), Kaas-Hansen, B.S., Kent, S., Khosla, S., Kolovos, S., Lambert, C.G., Lei, J. (Johan) van der, Lynch, K.E., Makadia, R., Margulis, A.V., Matheny, M.E., Mehta, P., Morales, D.R., Morgan-Stewart, H., Mosseveld, M. (Mees), Newby, D., Nyberg, F. (Fredrik), Ostropolets, A., Park, RW, Prats-Uribe, A., Rao, G.A., Reich, C., Reps, J., Rijnbeek, P.R. (Peter), Sathappan, S.M.K., Schuemie, M.J. (Martijn), Seager, S., Sena, A.G., Shoaibi, A., Spotnitz, M., Suchard, M.A. (Marc), Torre, C.O., Vizcaya, D., Wen, H.N., Wilde, M. (Marcel) de, Xie, J.Q., You, S.C., Zhang, L., Zhuk, O., Ryan, P., and Prieto-Alhambra, D.
- Abstract
Background Hydroxychloroquine, a drug commonly used in the treatment of rheumatoid arthritis, has received much negative publicity for adverse events associated with its authorisation for emergency use to treat patients with COVID-19 pneumonia. We studied the safety of hydroxychloroquine, alone and in combination with azithromycin, to determine the risk associated with its use in routine care in patients with rheumatoid arthritis. Methods In this multinational, retrospective study, new user cohort studies in patients with rheumatoid arthritis aged 18 years or older and initiating hydroxychloroquine were compared with those initiating sulfasalazine and followed up over 30 days, with 16 severe adverse events studied. Self-controlled case series were done to further establish safety in wider populations, and included all users of hydroxychloroquine regardless of rheumatoid arthritis status or indication. Separately, severe adverse events associated with hydroxychloroquine plus azithromycin (compared with hydroxychloroquine plus amoxicillin) were studied. Data comprised 14 sources of claims data or electronic medical records from Germany, Japan, the Netherlands, Spain, the UK, and the USA. Propensity score stratification and calibration using negative control outcomes were used to address confounding. Cox models were fitted to estimate calibrated hazard ratios (HRs) according to drug use. Estimates were pooled where the I2 value was less than 0·4. Findings The study included 956 374 users of hydroxychloroquine, 310 350 users of sulfasalazine, 323 122 users of hydroxychloroquine plus azithromycin, and 351 956 users of hydroxychloroquine plus amoxicillin. No excess risk of severe adverse events was identified when 30-day hydroxychloroquine and sulfasalazine use were compared. Self-controlled c
- Published
- 2020
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