Use of Janus Kinase Inhibitors Before and After European Medicines Agency Safety Recommendations

Patrick-Pascal Strunz¹, Linus Maximilian Risser², Matthias Englbrecht³, Torsten Witte⁴, Matthias Froehlich⁵, Marc Schmalzing⁶, Michael Gernert⁷, Peter Bartz-Bazzanella⁸, Sebastian Hueper⁹, Cay von Der Decken¹⁰, Georg Gauler¹¹, Susanna Spaethling-Mestekemper¹², Christoph Kuhn¹³, Kirsten Karberg¹⁴, Wolfgang Vorbrueggen¹⁵, Martin Welcker¹⁶ and Stefan Kleinert¹⁷, ¹University hospital of Wuerzburg, Wuerzburg, Germany, ²Hannover Medical School, Hannover, Germany, ³Freelance Healthcare Data Scientist, Eckental, ⁴Dept of Immunology and Rheumatology, Hannover, Germany, ⁵Uniklinikum Wuerzburg, Medizinische Klinik II, Wuerzburg, Germany, ⁶University Hospital Wuerzburg, Würzburg, Germany, ⁷Medicine II, Division Rheumatology/Clinical Immunology, University Hospital of Wuerzburg, Wuerzburg, ⁸Rhein-Maas Klinikum, Wuerselen, Germany, ⁹Praxis für Rheumatologie und Osteologie, Hildesheim, Germany, ¹⁰Klinik für Internistische Rheumatologie, Rhein-Maas-Klinik Wuerselen, Würselen, ¹¹rheumapraxis, Osnabrück, Germany, ¹²Rheumapraxis Muenchen, Muenchen, Germany, ¹³Praxis für Rheumatologie, Karlsruhe, Germany, ¹⁴Rheumatologisches Versorgungszentrum Steglitz, Berlin, Germany, ¹⁵RheumaDatenRhePort GbR, Wuerselen, Germany, ¹⁶Medizinisches Versorgungszentrum für Rheumatologie Dr. M. Welcker GmbH, Planegg, Germany, ¹⁷Praxisgemeinschaft Rheumatologie - Nephrologie (PGRN), Erlangen, Germany

Meeting: ACR Convergence 2024

Keywords: Cardiovascular, Epidemiology, rheumatoid arthritis, Women's health

Session Information

Date: Saturday, November 16, 2024

Title: RA – Treatment Poster I

Session Type: Poster Session A

Session Time: 10:30AM-12:30PM

Background/Purpose: Safety recommendations for Janus kinase inhibitors (JAKi) issued by the European Medical Agency (EMA) in 2023 could potentially influence prescription patterns for drugs used to treat rheumatoid arthritis (RA), but little is known about the impact of these recommendations in routine clinical care.

Methods: We retrospectively analyzed the German RHADAR rheumatology database¹ for adult patients with RA and documentation of a new therapy with a JAKi, tumour necrosis factor inhibitor (TNFi), or interleukin-6 receptor inhibitor (IL-6Ri). Data were grouped into half-yearly intervals from quarter (Q)2/2020 to Q3/2023. The period from Q4/2022 to Q1/2023 immediately followed the initial EMA endorsement of Pharmacovigilance Risk Assessment Committee (PRAC) ² recommendations and Q2/2023-Q3/2023 immediately followed the direct healthcare provider communication (DHPC) ³ containing the new safety JAKi recommendations.

Results: Between April 1, 2020 and September 23, 2023, 3008 newly initiated therapies for TNFi (1499 [49.8%]), JAKi (1126 [37.4%]), and IL-6Ri (383 [12.7%]) were documented by the treating physicians. JAKi were increasingly used in the first two half-year periods (from 29.7% of these therapies in Q2/2020-Q3/2020 to 46.7% in Q2/2021-Q3/2021; odds ratio [OR] 2.08; p< 0.001). The proportion of initiated JAKi therapies decreased significantly after the PRAC recommendations (32.9%; OR vs peak 0.56; p=0.001) and the DHPC letter (26.1%; OR vs peak 0.40; p< 0.001). JAKi were more likely to be used as >3^rd-line therapy in later time periods.

Conclusion: This exploratory study suggests that EMA safety recommendations for JAKi influenced treatment patterns of RA patients who received JAKi in Germany. The study showed a significant decrease in the percentage of new JAKi prescriptions and a shift towards using JAKi as later-line therapy post-safety recommendations.

Table 1 Patient characteristics at time of therapy initiation.

Fig. 1

Fig. 2

Disclosures: P. Strunz: AbbVie/Abbott, 6, 12, Travel grants, Eli Lilly, 12, Travel grants, Janssen, 12, Travel grants, Roche, 5; L. Risser: AbbVie/Abbott, 12, Support for attending meetings and/or travel, Biocon Germany, 12, Support for attending meetings and/or travel; M. Englbrecht: AbbVie, 2, Sanofi, 6; T. Witte: AbbVie, 5, Amgen, 5, AstraZeneca, 6, Bristol-Myers Squibb, 5, Celgene, 5, Chugai, 5, Gilead, 5, GlaxoSmithKlein(GSK), 6, Janssen, 5, Lilly, 5, MSD, 5, Mylan, 5, Novartis, 5, Pfizer, 5, Roche, 5, UCB, 5; M. Froehlich: Galapagos, 6, Novartis, 12, Travel costs; M. Schmalzing: AbbVie/Abbott, 1, 6, Amgen, 1, AstraZeneca, 1, 6, Boehringer-Ingelheim, 1, 5, 6, Celgene, 5, Chugai/Roche, 1, 5, 6, Eli Lilly, 1, EUSA-Pharma, 1, 6, Galapagos, 1, 5, 6, Gilead, 1, 6, Janssen, 1, 6, Medac, 1, 5, Mylan, 5, 6, Novartis, 1, 5, 6, onkowissen.de, 1, Sandoz, 1, UCB, 1, 5; M. Gernert: None; P. Bartz-Bazzanella: AbbVie/Abbott, 6, Boehringer-Ingelheim, 6, Eli Lilly, 6, Novartis, 5, 6; S. Hueper: AbbVie/Abbott, 6, Novartis, 11, sandoz, 11, UCB, 12, Congress fees, travel expenses; C. von Der Decken: AbbVie/Abbott, 12, Versorungssymposium 2024, Galapagos/Alphasigma, 12, DGRh-Kongress 2023 and 2024; G. Gauler: AbbVie/Abbott, 6, Eli Lilly, 1, Novartis, 6, UCB, 6; S. Spaethling-Mestekemper: AbbVie/Abbott, 6, Boehringer-Ingelheim, 6, Eli Lilly, 6, GlaxoSmithKlein(GSK), 6, Janssen, 6, Novartis, 6, UCB, 6; C. Kuhn: None; K. Karberg: None; W. Vorbrueggen: None; M. Welcker: AbbVie/Abbott, 1, 5, 6, Boehringer-Ingelheim, 1, 5, 6, Eli Lilly, 1, 6, Gilead, 1, 6, Novartis, 1, 5, 6; S. Kleinert: AbbVie/Abbott, 6, Chugai, 6, Novartis, 5, 6.

To cite this abstract in AMA style:

Strunz P, Risser L, Englbrecht M, Witte T, Froehlich M, Schmalzing M, Gernert M, Bartz-Bazzanella P, Hueper S, von Der Decken C, Gauler G, Spaethling-Mestekemper S, Kuhn C, Karberg K, Vorbrueggen W, Welcker M, Kleinert S. Use of Janus Kinase Inhibitors Before and After European Medicines Agency Safety Recommendations [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/use-of-janus-kinase-inhibitors-before-and-after-european-medicines-agency-safety-recommendations/. Accessed .

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