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Drug-induced systemic lupus: revisiting the ever-changing spectrum of the disease using the WHO pharmacovigilance database
  1. Laurent Arnaud1,2,
  2. Philippe Mertz1,2,
  3. Pierre-Edouard Gavand2,3,
  4. Thierry Martin2,3,
  5. François Chasset4,
  6. Martine Tebacher-Alt5,
  7. Aude Lambert5,
  8. Charlotte Muller5,
  9. Jean Sibilia1,2,
  10. Bénédicte Lebrun-Vignes6,
  11. Joe-Elie Salem6
  1. 1 Service de rhumatologie, Hôpitaux Universitaires de Strasbourg, Laboratoire d'Immuno Rhumatologie Moléculaire, INSERM UMR_S1109, Strasbourg, France
  2. 2 Centre National de Références des Maladies Systémiques et Autoimmunes Rares Est Sud-Ouest (RESO), Université de Strasbourg, Strasbourg, France
  3. 3 Service de Médecine Interne et Immunologie Clinique, Hôpitaux Universitaires de Strasbourg, Strasbourg, France
  4. 4 Assistance Publique Hôpitaux de Paris (AP-HP), Service de Dermatologie et d'Allergologie, Hôpital Tenon, Paris, France
  5. 5 Service de pharmacovigilance, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Strasbourg, France
  6. 6 AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, Regional Pharmacovigilance Center, INSERM, Sorbonne Universités, Paris, France
  1. Correspondence to Professor Laurent Arnaud, Department of rheumatology, Hôpitaux Universitaires de Strasbourg & Centre National de Références des Maladies Systémiques Rares (RESO), Strasbourg, France; laurent.arnaud{at}


Objective Drug-induced lupus (DIL) is an idiosyncratic side effect of treatments in which symptoms overlap with those of systemic lupus erythematosus (SLE). The spectrum of DIL constantly evolves with that of the pharmacopoeia. Here, we used VigiBase, the WHO global individual case safety reports (ICSRs) database, to identify the main drugs associated with DIL.

Methods We analysed all ICSRs classified as ‘systemic lupus erythematosus’ according to the Medical Dictionary for Drug Regulatory Activities term (preferred term level) in VigiBase. The drugs considered in the analysis were those not used to treat SLE, with a positive lower end of the 95% credibility interval for the information component (IC025) ≥0, an indicator value for disproportionate Bayesian reporting.

Results A total of 12 166 DIL ICSRs were identified using VigiBase. From those, 8163 ICSRs reporting on 118 suspected drugs with IC025 ≥0 were extracted. The median age at DIL onset was 49 years and the female to male sex ratio was 4.3. The median delay between start of suspected treatment and DIL occurrence was 172 days. DIL was reported as serious adverse event in 55.4%. Among the 118 suspected drugs, 42 had not been previously reported in association with DIL. The drugs associated with the highest number of DIL cases were infliximab, adalimumab, etanercept, procainamide and hydralazine.

Conclusion This study enables the identification of 118 drugs associated with DIL. The list of suspected drugs may prove useful to physicians when confronted with potential DIL cases.

Trial registration number NCT03480529.

  • drug-induced lupus
  • systemic lupus erythematosus
  • adverse-drug reaction
  • pharmacovigilance

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  • Handling editor Josef S Smolen

  • Contributors All authors were involved in drafting the article or revising it critically for important intellectual content, and all authors approved the final version to be published. Study conception and design: LA, PM, BL-V, J-ES. Acquisition of data: LA, PM, BL-V, J-ES. Analysis and interpretation of data: LA, PM, P-EG, TM, FC, MT-A, AL, CM, JS, BL-V, J-ES.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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