Long-term Safety of Biologics versus Conventional Synthetic Treatments in Systemic Juvenile Idiopathic Arthritis Patients

Ana Isabel Rebollo-Giménez¹, Luca Carlini², Yulia Vyzhga³, Silvia Rosina⁴, Ekaterina Alexeeva⁵, Charlotte Myrup⁶, Silvia Magni Manzoni⁷, Maria Trachana⁸, Valda Stanevicha⁹, Constantin Ailioaie¹⁰, Elena Tsitsami¹¹, Alexis-Virgil Cochino¹², Chiara Pallotti¹³, Silvia Scala¹³, Angela Pistorio¹⁴, Sebastiaan Vastert¹⁵, Joost F. Swart¹⁶ and Nicolino Ruperto¹⁷, ¹IRCCS Istituto Giannina Gaslini, UOC Reumatologia e Malattie Infiammatorie, Genova, Italy, ²IRCCS Istituto Giannina Gaslini, UOC Reumatologia e Malattie Autoinfiammatorie, Genova, Italy, ³IRCCS Istituto Giannina Gaslini, UOC Reumatologia e Malattia Infiammatorie, Genova, Italy, ⁴IRCCS Istituto Giannina Gaslini, Genova, Italy, ⁵Federal State Autonomous Institution “National Medical Research Center of Children's Health”, Ministry of Health of the Russian Federation, Moscow, Russia, ⁶Rigshospitalet, Pediatric rheumatology unit 4272, Copenhagem, Denmark, ⁷IRCCS Ospedale Pediatrico Bambino Gesù, Division of Rheumatology, Roma, Italy, ⁸Hippokration General Hospital, Thessaloniki University School of Medicine, First Department of pediatrics, Pediatric Immunology and Rheumatology Referral Center, Thessaloniki, Greece, ⁹Riga Stradins University, Children University Hospital, Riga, Latvia, ¹⁰Alexandru Ioan Cuza University of Iasi, Iasi, Romania, ¹¹Aghia Sophia Childrens Hospital, First Department of Pediatrics, University of Athens Medical School, Athens, Greece, ¹²Institute for Mother and Child Care, Pediatrics, Bucharest, Romania, ¹³IRCCS Istituto Giannina Gaslini, U.O.C. Pediatric and Rheumatology Clinic, PRINTO, Genova, Italy, ¹⁴IRCCS Istituto Giannina Gaslini, Direzione Scientifica, Genova, Italy, ¹⁵Wilhelmina Children’s Hospital, Department of Pediatric Immunology and Rheumatology, Utrecht, The Netherlands, Utrecht, Netherlands, ¹⁶Wilhelmina Children’s Hospital, Department of Pediatric Immunology and Rheumatology, Utrecht, Netherlands, ¹⁷IRCCS Istituto Giannina Gaslini, UOSID Centro Trial, PRINTO, Genova, Italy

Meeting: 2023 Pediatric Rheumatology Symposium

Keywords: Biologicals, Juvenile idiopathic arthritis, Pharmacoepidemiology, registry

Session Information

Date: Friday, March 31, 2023

Title: Posters: Clinical and Therapeutic II

Session Type: Poster Session B

Session Time: 5:00PM-6:00PM

Background/Purpose: The better understanding of systemic Juvenile Idiopathic Arthritis (sJIA) pathogenesis and availability of new drugs, such as biologic disease-modifying anti-rheumatic drugs (bDMARDs) specifically dedicated to sJIA, have led to treatment advances that have ameliorated the disease outcome and reduced the use of glucocorticoids. However, published evidence on long term safety data regarding biologic therapies in sJIA is still limited.The objective of the study was to compare the adverse events (AEs) of at least moderate intensity and serious AEs in sJIA patients treated with biologics compared with a cohort treated with csDMARDs (conventional synthetic disease-modifying anti-rheumatic drugs).

Methods: Patients with sJIA, classified according to the International League of Associations for Rheumatology (ILAR), enrolled in the Pharmachild Registry since 2011 and followed up until 31 December 2022 were included. All patients had received at least one bDMARDs or csDMARDs. Those who switched to more than one treatment during the period of observation were assigned only to one group according to the longest time of drug exposure. AEs are reported according to the latest release of the Medical Dictionary for Regulatory Activities (MedDRA, Version 23.1) and were grouped into highest term System Organ Classes (SOCs). Frequency of SOCs were analysed. Events repeated for the same SOC in the same patient were counted once in the analysis.

Results: A total of 980 sJIA patients were enrolled, 353 treated with bDMARDs and 627 treated with csDMARDs. The distribution of demographic data was similar in both cohorts, with the exception that the prescription of csDMARDs compared to bDMARDs was more frequent in other continents compared to Europe. As shown in the table, patients in the bDMARDs group developed more frequently infections and infestations (41.4%), skin and subcutaneous tissue disorders (11.3%) and general disorders and administration site conditions (8.2%) than patients treated with csDMARDs (all p< 0.0001). On the other hand, endocrine disorders were more frequent in the csDMARDs group (7.3%, p=0.03). The distribution between other SOCs was similar in children treated with bDMARDs compared with csDMARDs.

Conclusion: Patients in the bDMARD group had a higher prevalence of infections and skin manifestations when compared with the csDMARDs cohort.

Table. Demographics characteristics, number of AEs and frequencies in the complete set. Data presented as n (%). Events with a frequency of > 30 by overall SOC are presented. AEs: adverse events; SOC: system organ class; bDMARDs: biologic disease-modifying anti-rheumatic drugs; csDMARDs conventional synthetic disease-modifying anti-rheumatic drugs.

Disclosures: A. Rebollo-Giménez: None; L. Carlini: None; Y. Vyzhga: None; S. Rosina: None; E. Alexeeva: AbbVie/Abbott, 5, Amgen, 5, Bristol-Myers Squibb(BMS), 5, Centocor, 5, Eli Lilly, 5, Merck/MSD, 5, Novartis, 5, 6, Pfizer, 5, 6, Roche, 5, 6, Sanofi, 5; C. Myrup: None; S. Magni Manzoni: None; M. Trachana: None; V. Stanevicha: None; C. Ailioaie: None; E. Tsitsami: None; A. Cochino: None; C. Pallotti: None; S. Scala: None; A. Pistorio: None; S. Vastert: Novartis, 6, SOBI, 5, 6; J. F. Swart: None; N. Ruperto: Amgen, 6, AstraZeneca, 6, Aurinia, 6, Bayer, 6, Bridge, 6, Brystol Myers and Squibb, 5, 6, Cambridge Healthcare Research, 6, Celgene, 6, Domain Therapeutic, 6, Eli Lilly, 5, 6, EMD Serono, 6, F Hoffmann-La Roche, 5, Glaxo Smith Kline, 6, Idorsia, 6, inMed, 6, Janssen, 6, Novartis, 5, 6, Pfizer, 5, 6, Sobi, 5, 6, UCB, 6.

To cite this abstract in AMA style:

Rebollo-Giménez A, Carlini L, Vyzhga Y, Rosina S, Alexeeva E, Myrup C, Magni Manzoni S, Trachana M, Stanevicha V, Ailioaie C, Tsitsami E, Cochino A, Pallotti C, Scala S, Pistorio A, Vastert S, F. Swart J, Ruperto N. Long-term Safety of Biologics versus Conventional Synthetic Treatments in Systemic Juvenile Idiopathic Arthritis Patients [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 4). https://acrabstracts.org/abstract/long-term-safety-of-biologics-versus-conventional-synthetic-treatments-in-systemic-juvenile-idiopathic-arthritis-patients/. Accessed .

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