Risk of hydroxychloroquine alone and in combination with azithromycin in the treatment of rheumatoid arthritis: a multinational, retrospective study
Lane et al.,
Risk of hydroxychloroquine alone and in combination with azithromycin in the treatment of rheumatoid..,
The Lancet Rheumatology, doi:10.1016/S2665-9913(20)30276-9
Retrospective study of RA patients using HCQ vs. sulfasalazine (another DMARD). HCQ treatment showed no increased risk in the short term (up to 30 days) among patients with RA. Long term use was associated with excess cardiovascular mortality.
Addition of AZ increased the risk of cardiovascular mortality with combined use up to 30 days. This is several times longer than typical COVID-19 use. This result also comes from just 2 of the 14 databases, with the negative result from just one database (VA) and much lower statistically insignifant difference in mortality from the other database (Clinformatics).
Confounding by indication. Patients conditions vary, the severity of a patient's RA or other conditions was not taken into account. Results varied widely across different databases, and different subsets of databases were used in different analyses. Baseline risk of serious adverse events unknown. Health care database analysis subject to misclassification errors.
Lane et al., 21 Aug 2020, peer-reviewed, 62 authors.
Abstract: Articles
Risk of hydroxychloroquine alone and in combination with
azithromycin in the treatment of rheumatoid arthritis:
a multinational, retrospective study
Jennifer C E Lane*, James Weaver*, Kristin Kostka, Talita Duarte-Salles, Maria Tereza F Abrahao, Heba Alghoul, Osaid Alser,
Thamir M Alshammari, Patricia Biedermann, Juan M Banda, Edward Burn, Paula Casajust, Mitchell M Conover, Aedin C Culhane,
Alexander Davydov, Scott L DuVall, Dmitry Dymshyts, Sergio Fernandez-Bertolin, Kristina Fišter, Jill Hardin, Laura Hester, George Hripcsak,
Benjamin Skov Kaas-Hansen, Seamus Kent, Sajan Khosla, Spyros Kolovos, Christophe G Lambert, Johan van der Lei, Kristine E Lynch,
Rupa Makadia, Andrea V Margulis, Michael E Matheny, Paras Mehta, Daniel R Morales, Henry Morgan-Stewart, Mees Mosseveld, Danielle Newby,
Fredrik Nyberg, Anna Ostropolets, Rae Woong Park, Albert Prats-Uribe, Gowtham A Rao, Christian Reich, Jenna Reps, Peter Rijnbeek,
Selva Muthu Kumaran Sathappan, Martijn Schuemie, Sarah Seager, Anthony G Sena, Azza Shoaibi, Matthew Spotnitz, Marc A Suchard,
Carmen O Torre, David Vizcaya, Haini Wen, Marcel de Wilde, Junqing Xie, Seng Chan You, Lin Zhang, Oleg Zhuk, Patrick Ryan,
Daniel Prieto-Alhambra, on behalf of the OHDSI-COVID-19 consortium
Summary
Lancet Rheumatol 2020;
2: e698–711
Published Online
August 21, 2020
https://doi.org/10.1016/
S2665-9913(20)30276-9
See Comment page e652
*Contributed equally
Centre for Statistics in
Medicine, Nuffield Department
of Orthopaedics,
Rheumatology, and
Musculoskeletal Sciences,
University of Oxford, Oxford,
UK (J C E Lane MRCS, E Burn MSc,
S Kolovos PhD,
A Prats-Uribe MPH, J Xie MSc,
Prof D Prieto-Alhambra PhD);
Janssen Research and
Development, Titusville, NJ,
USA (J Weaver MSc,
M M Conover PhD, J Hardin PhD,
L Hester PhD, R Makadia PhD,
G A Rao MD, J Reps PhD,
M Schuemie PhD, A G Sena BA,
A Shoaibi PhD, P Ryan PhD);
Real World Solutions, IQVIA,
Cambridge, MA, USA
(K Kostka MPH,
H Morgan-Stewart PhD,
C Reich MD, S Seager BA,
C O Torre MSc); Fundació
Institut Universitari per a la
Recerca a l’Atenció Primària de
Salut Jordi Gol i Gurina
(IDIAPJGol), Barcelona, Spain
(T Duarte-Salles PhD, E Burn,
S Fernandez-Bertolin MSc,
Prof D Prieto-Alhambra); Faculty
of Medicine, University of
Sao Paulo, Sao Paulo, Brazil
(M T F Abrahao PhD); Faculty of
Medicine, Islamic University
of Gaza, Palestine
(H Alghoul MD); Massachusetts
General Hospital, Harvard
Medical School, Boston, MA,
USA (O Alser MD); Medication
e698
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..
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