Long Term Safety of Drugs in Systemic Juvenile Idiopathic Arthritis

Ana Isabel Rebollo Gimenez¹, Luca Carlini², Paivi Miettunen³, Ekaterina Alexeeva⁴, Charlotte Myrup⁵, Rebecca Nicolai⁶, Maria Trachana⁷, Valda Stenevicha⁸, Constantin Ailioaie⁹, Elena Tsitsami¹⁰, Alexis-Virgil Cochino¹¹, Chiara Pallotti¹², Silvia Scala¹², Angela Pistorio¹³, Sebastiaan Vastert¹⁴, Joost Swart¹⁵ and Nicolino Ruperto¹⁶, ¹IRCCS Istituto Giannina Gaslini, UOC Reumatologia e Malattie Autoinfiammatorie, Genoa, Italy, ²IRCCS Istituto Giannina Gaslini, UOC Servizio di Sperimentazioni Cliniche Pediatriche, PRINTO, Genoa, Italy, ³University of Calgary and Alberta Children’s Hospital, Calgary, AB, Canada, ⁴Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russia, ⁵Pediatric rheumatology unit 4272, Rigshospitalet, Copenhagen, Denmark, ⁶Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy, ⁷First Department of pediatrics, Pediatric Immunology and Rheumatology Referral Center, Hippokration General Hospital, Thessaloniki University School of Medicine, Thessaloniki, Greece, ⁸Department of Paediatrics, Riga Stradins University, Children University Hospital, Riga, Latvia, ⁹Pediatric Rheumatology , Alexandru Ioan Cuza University of Iasi, Iasi, Romania, ¹⁰Pediatric Rheumatology Unit, 1st Department of Pediatrics, Children's Hospital "Aghia Sophia", University of Athens, Athens, Greece, ¹¹First Department of Pediatrics, University of Athens Medical School, Aghia Sophia Childrens Hospital, Athens, Greece, ¹²Pediatric and Rheumatology Clinic, IRCCS Istituto Giannina Gaslini, Genoa, Italy, ¹³Direzione Scientifica, IRCCS Istituto Giannina Gaslini, Genoa, Italy, ¹⁴University Medical Center Utrecht, Utrecht, Netherlands, ¹⁵Wilhelmina Children's Hospital / UMC Utrecht, Utrecht, Netherlands, ¹⁶IRCCS Istituto Giannina Gaslini, UOSID Centro Trial, Genova, Italy

Meeting: ACR Convergence 2023

Keywords: Biologicals, Drug toxicity, Juvenile idiopathic arthritis, Pediatric rheumatology, registry

Session Information

Date: Sunday, November 12, 2023

Title: (0345–0379) Pediatric Rheumatology – Clinical Poster I: JIA

Session Type: Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Evidence on treatment safety in systemic juvenile idiopathic arthritis (sJIA) is limited. Our objective was to evaluate the safety profile of drugs in the initial 24-months since disease onset.

Methods: Children from Pharmachild were classified into 4 mutually exclusive groups according to the treatment in the first 6 months from sJIA onset. Descriptive data, incidence rates (95% CI), survival curve, log rank test, and Cox multivariate regression model are reported.

Results: A total of 701/992 (71%) sJIA patients were classified as: 1) glucocorticoids (N=161), 2) biologic (b) DMARDS (N=69); 3) conventional synthetic (cs) DMARDs (N=65) and 4) combinations of these drugs (N=406).

In the initial 6 months, bDMARDs and combination therapy had the highest rate of AEs, serious AE and events of special interest. Infections were the most common AEs (N, IR*100PY-95%CI) in bDMARDs group (7, 32.94 [15.70-69.10]). Gastrointestinal disorders and general disorders were most frequent in the bDMARDs group (6, 28.24 [12.69-62.85]). Kaplan Meier’s showed the bDMARDs group experienced more AE and sooner when compared to the other groups (log rank test p< 0.0001). The risk of any AE was significantly higher in bDMARDs, hazard ratio (HR) 8.8 (95% CI: 3.5-22.1)

In the following 18 months the number and the risk of any AE was increased in the combination therapy group (HR 4.5; 95% CI: 1.1-18.6).

Conclusion: bDMARDs or combination therapy in sJIA patients was associated with a higher risk of AE in the first six months meanwhile in the following 18 months combination therapy group had the highest risk of AE.

Disclosures: A. Rebollo Gimenez: None; L. Carlini: None; P. Miettunen: None; E. Alexeeva: AbbVie, 5, 6, AMGen, 5, Bristol-Myers Squibb(BMS), 5, Eli Lilly, 5, Merck/MSD, 5, Novartis, 5, 6, Pfizer, 5, 6, Roche, 5, 6, Sanofi, 5, USB Pharma, 5; C. Myrup: None; R. Nicolai: None; M. Trachana: None; V. Stenevicha: None; C. Ailioaie: None; E. Tsitsami: None; A. Cochino: None; C. Pallotti: None; S. Scala: None; A. Pistorio: None; S. Vastert: Novartis and SOBI, 2; J. Swart: None; N. Ruperto: Ablynx, 2, 6, AstraZeneca-Medimmune, 2, 6, Bayer, 2, 6, Biogen, 2, 6, Boehringer-Ingelheim, 2, 6, Bristol-Myers Squibb (BMS), 2, 5, 6, Celgene, 5, 12, Personal Fees, Non-Financial Support, Eli Lilly, 2, 5, 6, EMD Serono, 2, 6, F. Hoffman-La Roche, 2, 5, 6, GlaxoSmithKlein (GSK), 2, 5, 6, Janssen, 2, 5, 6, Merck/MSD, 2, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, R-Pharma, 2, 6, Sinergie, 2, 6, Sobi, 2, 5, 6, UCB, 2, 5.

To cite this abstract in AMA style:

Rebollo Gimenez A, Carlini L, Miettunen P, Alexeeva E, Myrup C, Nicolai R, Trachana M, Stenevicha V, Ailioaie C, Tsitsami E, Cochino A, Pallotti C, Scala S, Pistorio A, Vastert S, Swart J, Ruperto N. Long Term Safety of Drugs in Systemic Juvenile Idiopathic Arthritis [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/long-term-safety-of-drugs-in-systemic-juvenile-idiopathic-arthritis/. Accessed .

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