Efficacy and safety of levilimab in the treatment of rheumatoid arthritis in real-life clinical practice: first results of the HELIOS observational study
Rattachement africain : ru, us. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
The efficacy and safety of levilimab (LVL) in patients with active rheumatoid arthritis (RA) has been confirmed in controlled clinical trials. This article presents the results of a preliminary analysis of a non-interventional observational study of LVL in RA patients. Objective: to evaluate the efficacy and safety of LVL in the treatment of patients with RA in real-world clinical practice. Materials and methods. The HELIOS study is a retrospective-prospective, multicenter, non-interventional study of retention rate of LVL therapy and the safety of LVL in patients with RA in real-world clinical practice. Patients received medical care, including LVL, according to routine clinical practice for the treatment of RA and Russian instructions for medical use of the drug. This article presents the results of an analysis of the efficacy and safety of LVL after 12 and 24 weeks of treatment. Efficacy was assessed using the DAS28-CRP/ESR, SDAI, CDAI and patient assessment of pain, fatigue and morning stiffness according to VAS (0–100 mm). Results and discussion. 524 patients from 42 medical centers in the Russian Federation were enrolled in the study from June 2022 to November 2023. The majority of patients were female (83.2 %) and the mean age of patients was 53 years. A statistically significant decrease in DAS28-CRP/ESR, SDAI, CDAI, patient assessment of pain, fatigue and morning stiffness (VAS) was observed after 12 and 24 weeks of treatment, regardless of previous treatment with biologics or Jak inhibitors (JAKi). LVL was well tolerated by patients, the most frequently reported adverse events were infections, changes in peripheral blood and laboratory abnormalities characteristic of treatment with IL-6R inhibitors. Conclusion. In real-world clinical practice, LVL has been shown to be highly effective and well tolerated in patients with RA when prescribed as the first biologic disease-modifying antirheaumatic drus (bDMARD) and after switching from other bDMARDs or JAKi.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Efficacy and safety of levilimab in the treatment of rheumatoid arthritis in real-life clinical practice: first results of the HELIOS observational study
- Date Crossref
- 14/06/2024
- Éditeur
- IMA Press, LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Ministry of Health of the Russian Federation pays non établi dans la noticeOrganisme public
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Association of Rheumatologists of Russia pays non établi dans la noticeStructure de recherche
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North-Western State Medical University named after I.I. Mechnikov pays non établi dans la noticeUniversité ou école supérieure
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Ulyanovsk Regional Clinical Hospital pays non établi dans la noticeÉtablissement de santé
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National Medical and Surgical Center named after N.I. Pirogov pays non établi dans la noticeStructure de recherche
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Regional Children's Hospital No1 pays non établi dans la noticeÉtablissement de santé
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Autonomous Healthcare pays non établi dans la noticeÉtablissement de santé
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Moscow City Hospital No 29 pays non établi dans la noticeÉtablissement de santé
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Regional Public Health Care Institution "City Hospital No. 5 pays non établi dans la noticeÉtablissement de santé
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City Clinical Hospital pays non établi dans la noticeÉtablissement de santé
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Sechenov University pays non établi dans la noticeUniversité ou école supérieure
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Clinical Hospital No. 8 pays non établi dans la noticeÉtablissement de santé
Ministry of Health of the Russian Federation, Association of Rheumatologists of Russia et North-Western State Medical University named after I.I. Mechnikov, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.