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Background Baricitinib (BCT) and tofacitinib (TFC) are the most widely used JAK inhibitors worldwide and both were approved in Spain in 2017.
Data from Oral Surveillance study showed in 2021 an increased risk of malignancies and major adverse cardiovascular events (MACEs) in patients treated with TFC versus anti-TNF drugs. However, there is no clear position among rheumatologists regarding the risk of MACE, thromboembolic events (TEE) or other safety concerns of JAK inhibitors.
Although JAK inhibitors have a common mechanism of action, each drug has specificities such as selective affinity to different targets, pharmacodynamics, metabolism and dosing, conferring differences between drugs. Therefore, it is to be expected that the safety profile may be different.
Objectives The aim of this study is to collect real world data from Spanish patients to analyze efficacy trends, daily use patterns and a descriptive analysis of the safety profile of rheumatoid arthritis treatments in southern Spain.
Methods A multicenter, observational, retrospective study was conducted, collecting data from patients with rheumatoid arthritis previously treated with methotrexate (MTX) and other prior biologic therapies.
Results Data from 270 patients were analyzed, 73% were female, the mean age was 58 years (SD: 12,7) and the mean age at diagnosis was 47 years (SD:14,33). Of the population, 95,1% had some risk factor for MACE or TEE; specifically 7,5% had previous cardiac events, 2,6% and 9,4% had previous TEE and malignancies, respectively. The distribution of baseline treatment is shown in the Table 1.
Median use of prior disease-modifying treatments (DMT) was 1 for the total population, but 2 for BCT patients. BCT patients had 10,5 (SD: 9,0) mean years of disease progression and initiated treatment at 57 (SD: 12,25) years mean age.
After the first 12 months of follow-up, there was a trend towards reduce the use of NSAIDs (28,9% to 24,2%), prednisone 85% to 58,4%) and MTX (46,2% to 36,6%). Simultaneously, Disease Activity Score 28 (DAS28), VSG and PCR also decreased during the period from 4,92 (SD:0,84), 24,41 (SD: 15,78) mm/h and 11,89 (SD: 9,69) mg/l to 3,06 (SD: 1,13), 20,79 (SD: 13,31) mm/h, and 8,21 (SD: 9,14) mg/l respectively.
BCT safety profile was well tolerated, with 33 adverse events at 6 months of follow-up and 3 serious adverse events (TEE, pneumonia and stroke) during the period. Of BCT population, 57,6% stopped treatment due to toxicity or lack of efficacy.
Conclusion Taking into account the heterogenicity and the age of our population, these preliminary results showed low risk of MACE and cancers with BCT for the Spanish cohort. Future analysis is guarantee in order to understand the safety profile in the long term.
References
Acknowledgements: NIL.
Disclosure of Interests Esteban Rubio Romero Speakers bureau: Lilly, Galapagos, Abbvie, Paid instructor for: Lilly, Galapagos, Abbvie, Consultant of: Lilly, Galapagos, Abbvie, Grant/research support from: Lilly, Adela Gallego Speakers bureau: Lilly, Galapagos, Abbvie, Paid instructor for: Lilly, Galapagos, Abbvie, Consultant of: Lilly, Galapagos, Abbvie, Marta Llanes Speakers bureau: Lilly, Galapagos, Abbvie, Paid instructor for: Lilly, Galapagos, Abbvie, Consultant of: Lilly, Galapagos, Abbvie, ELOY DELGADO VIDAL: None declared.
Keywords: Safety, Rheumatoid arthritis, Descriptive studies
DOI: 10.1136/annrheumdis-2023-eular.5600