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Low plasma belimumab levels as an indicator of poor adherence to belimumab in patients with systemic lupus erythematosus
  1. Ludovic Trefond1,2,
  2. Noël Zahr3,
  3. Raphael Lhote1,
  4. Micheline Pha1,
  5. Miguel Hié1,
  6. Makoto Miyara4,5,
  7. Matthias Papo6,
  8. Quentin Moyon6,
  9. Pierre Hausfater6,
  10. Francois Chasset7,
  11. Julien Haroche4,6,
  12. Fleur Cohen-Aubart6,
  13. Alexis Mathian1,4,
  14. Zahir Amoura4,6
  1. 1 Assistance Publique-Hôpitaux de Paris (AP-HP), Groupement Hospitalier Pitié-Salpêtrière, Centre de Référence pour le Lupus, le Syndrome des anti-phospholipides et autres maladies auto-immunes rares, Service de Médecine Interne 2, Institut E3M, Paris, France
  2. 2 CHU Clermont Ferrand, Service de Médecine Interne, Hôpital Gabriel Montpied, Inserm U1071, INRA USC2018, M2iSH, Université Clermont Auvergne, Clermont-Ferrand, France
  3. 3 AP-HP, Sorbonne Université, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1901, Pharmacokinetics and Therapeutic Drug Monitoring Unit, UMR-S 1166, Paris, France
  4. 4 Centre d'Immunologie et des Maladies Infectieuses (CIMI-Paris), INSERM, Sorbonne Universite, Paris, France
  5. 5 Sorbonne Universite, AP-HP, Département d'Immunologie, Groupement Hospitalier Pitié-Salpêtrière, Paris, France
  6. 6 Sorbonne Université, Faculté de Médecine, AP-HP, Groupement Hospitalier Pitié-Salpêtrière, Centre de Référence pour le Lupus, le Syndrome des anti-phospholipides et autres maladies auto-immunes rares, Service de Médecine Interne 2, Institut E3M, Paris, France
  7. 7 Sorbonne Université, Faculté de Médecine, AP-HP, Service de Dermatologie et Allergologie, Hôpital Tenon, Paris, France
  1. Correspondence to Pr Zahir Amoura, Service de Médecine Interne 2, Institut E3M, Hôpital de la Pitié–Salpêtrière, 47–83, boulevard de l’Hôpital, 75651 Paris Cedex 13, France; zahir.amoura{at}aphp.fr

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Non-adherence is a significant issue in the treatment of systemic lupus erythematosus (SLE), associated with the risks of disease flare, early damage and 5-year mortality as demonstrated for hydroxychloroquine (HCQ).1 It is important for clinicians to objectively assess adherence to treatments, especially in cases of resistance to standard of care treatment. For this purpose, serum, plasma or blood measurements of drugs with long elimination half-lives can help clinicians to identify patients with very low adherence to treatments, as previously shown for HCQ.2

Intravenous and subcutaneous belimumab (BLM) is an effective treatment for SLE3 4 progressively used as maintenance therapy. However, adherence to BLM poses a challenge when administered subcutaneously, as the physician does not know whether the treatment is truly administered. The aim of the study was (1) to assess adherence to BLM using questionnaires and measurements of its plasma levels; (2) to identify factors associated with non-adherence to BLM treatment and (3) to explore the links between the adherence to BLM and to HCQ. This single-centre study included consecutive patients treated with subcutaneous BLM from March 2023 to September 2023, regularly examined by physicians specialist in SLE. Adherence to BLM and HCQ was assessed using the Morisky Medication Adherence Scale 8 (MMAS-8) and the Medication Adherence Self-Report Inventory (MASRI) questionnaires for each of these drugs, at random times relative …

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Footnotes

  • LT and NZ are joint first authors.

  • Permission The MMAS-8 Scale, content, name, and trademarks are protected by US copyright and trademark laws. Permission for use of the scale and its coding is required. A license agreement is available from MMAR, LLC., www.moriskyscale.com.

  • Handling editor Josef S Smolen

  • LT and NZ contributed equally.

  • AM and ZA contributed equally.

  • Contributors LT, NZ, AM and ZA contributed to the conception and design of the study. LT, NZ, RL, MPh, MH, MM, MPa, QM, PH, FC, JH, FC-A, AM and ZA were involved in the acquisition of data. LT, NZ, AM and ZA contributed to the analysis and interpretation of data. All authors contributed to drafting and/or revising the manuscript.

  • 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 AM has received grant/research support from Sobi; participated in advisory board related to lupus for AstraZeneca; received payment for expert testimony for GSK; received support for attending meetings and/or travel from AstraZeneca, GSK, Novartis and Otsuka; received consulting fees, speaking fees and honoraria from AstraZeneca, GSK, Novartis and Otsuka. FC has received grant/research support from AstraZeneca; participated in advisory board related to lupus for AstraZeneca, GSK, Celgene and Principabio; received speaking fees and honoraria from AstraZeneca and GSK. ZA has received grant/research support from GSK, AstraZeneca, Roche, Novartis, Amgen; participated in advisory board related to lupus for GSK, AstraZeneca, Kezar, Amgen, Otsuka; Novartis received consulting fees, speaking fees and honoraria from AstraZeneca and GSK. The remaining authors declare no conflict of interest.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

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

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.