Abstract Background/Aims FILOSOPHY (NCT04871919) and PARROTFISH (NCT05323591) are ongoing, prospective, observational Phase 4 studies to assess effectiveness and safety of filgotinib in a real-world setting in Europe. Methods Patients aged ≥18 years with moderate to severe active rheumatoid arthritis (RA) prescribed filgotinib for the first time, and in accordance with the product label, were recruited. Safety assessments included the frequency of the most common treatment-emergent adverse events (TEAEs). Laboratory parameters were assessed at baseline, Month 12 and 24. Results This interim analysis includes 1,309 patients treated between May 2021 and January 2024, with a median follow-up of 366 days. At baseline, median (IQR) age was 56 (49-64) years. In total, 66.8% of patients were aged ≥65 years and/or had ≥1 cardiovascular risk factor (including ever smoked). At up to 24 months, 700 patients (53.5%) had experienced TEAEs, which were serious in 119 patients (9.1%) and led to premature treatment discontinuation in 127 patients (9.7%). The most frequent TEAEs (occurring in ≥ 2% of patients) were: COVID-19 (n = 100 7.6%), nausea (n = 61 4.7%), nasopharyngitis (n = 53 4.0%), headache (n = 39 3.0%), ineffective drug (n = 38 2.9%), fatigue (n = 37 2.8%), dizziness (n = 33 2.5%) and urinary tract infection (n = 30 2.3%). Physician-reported TEAEs related to the laboratory parameters assessed included hypercholesterolemia in 16 patients (1.2%), iron deficiency anemia in 6 patients (0.5%), increased transaminase level in 6 patients (0.5%), neutropenia in 4 patients (0.3%), increased alanine aminotransferase level in 4 patients (0.3%), increased blood cholesterol level in 3 patients (0.2%), anemia in 2 patients (0.2%), increased blood creatinine level in 2 patients (0.2%) and lymphopenia in 2 patients (0.2%). Weight increase was reported as a TEAE in 10 patients (0.8%). Laboratory measures generally remained stable from baseline up to 24 months (Table 1), and no differences were observed between filgotinib 100 mg and 200 mg. Conclusion Interim data from FILOSOPHY and PARROTFISH show that, in patients treated with filgotinib, TEAEs are in line with those previously reported. Laboratory parameters and BMI remained generally stable over time up to Month 24, which is consistent with findings from randomised clinical trials and real-life studies. Disclosure J. Galloway: Consultancies; AbbVie, Alfasigma S.p.A., Galapagos, Janssen, Lilly and Pfizer. Member of speakers’ bureau; AbbVie, Galapagos, Janssen, Lilly, Pfizer and UCB. Grants/research support; AstraZeneca, Janssen and Pfizer. K. Bevers: Consultancies; Alfasigma S.p.A. and Galapagos. N. Betteridge: Consultancies; Alfasigma S.p.A., Galapagos, Grünenthal, Ipsen and Sanofi. Member of speakers’ bureau; Galapagos, Grünenthal and Sanofi. D. Gatti: Consultancies; Amgen, Lilly, Mereo, MSD-Italia and UCB. Member of speakers’ bureau; Amgen, Lilly, Mereo, MSD-Italia and UCB. T.P. Debray: Consultancies; Alfasigma S.p.A., Biogen, Daiichi Sankyo, Galapagos and Gilead. C. Van der Donckt: Other; Employee of Alfasigma Belgium BV. E. Kinable: Other; Employee of Alfasigma Schweiz AG. I. Andreica: Consultancies; Alfasigma S.p.A.. Member of speakers’ bureau; Alfasigma S.p.A.. Other; Paid instructor: Chugai. S. Romero-Yuste: Consultancies; AbbVie, AstraZeneca, Lilly and UCB. Member of speakers’ bureau; AbbVie, AstraZeneca, GLP and Lilly. J. Vanhoof: None. J. Avouac: Consultancies; AbbVie and Galapagos. Member of speakers’ bureau; AbbVie, Galapagos, BMS, Lilly, Novartis and Pfizer. Grants/research support; BMS, Fresenius Kabi, Novartis and Pfizer.
Galloway et al. (Wed,) studied this question.
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