AB0569 PATIENT-REPORTED OUTCOMES (PROs), DISEASE ACTIVITY AND SAFETY IN 1,177 PATIENTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH FILGOTINIB FOR UP TO 18 MONTHS: INTERIM RESULTS FROM FILOSOPHY AND PARROTFISH (2024)

Abstract

Background: Real-world evidence provides insights into treatment effectiveness, safety and PROs beyond clinical trials. FILOSOPHY (NCT04871919) and PARROTFISH (NCT05323591) are prospective, observational Phase 4 studies ongoing in Europe and France.

Objectives: To report baseline characteristics, PROs, effectiveness and safety based on pooled data from the first 1,177 patients treated with filgotinib for up to 18 months.

Results: As of July 2023, 1,177 patients had been treated, with a median follow-up of 322 days; baseline characteristics are shown in Table 1. 50.8% of patients received filgotinib monotherapy; 48.8% received filgotinib in combination with conventional synthetic disease-modifying antirheumatic drugs. 91.6% received filgotinib 200 mg; 8.4% received filgotinib 100 mg. 37.6% of patients were AT naïve; 62.4% were AT experienced. Pain and fatigue improved as early as Week 1. At Week 1, 39.2% and 46.6% of AT-naïve and AT-experienced patients, respectively, had a clinically meaningful improvement in VAS pain, and 42.9% and 44.4%, respectively, had a clinically meaningful improvement in FACIT-Fatigue score. Clinically meaningful changes were observed in patients followed up to Month 18 (Figure 1A and B). Work productivity and daily activity impairment improved from Week 1; improvements were observed in patients followed up to Month 18 (Figure 1C). Most patients initially had moderate to high disease activity. Improvements were seen as early as Month 1. By Month 18, DAS28-CRP of ≤2.6 was reported by 60.3% (82/136) while DAS28-CRP of >2.6 and ≤3.2 was reported by 15.4% (21/136) of patients; CDAI scores of ≤2.8 were reported by 36.8% (57/155) while scores of >2.8 and ≤10 were reported by 34.2% (53/155) of patients. Median (interquartile range) HAQ-DI was 1.4 (0.8, 1.8) at baseline (N=213), 0.8 (0.3, 1.4) at Month 1 (N=149) and 0.8 (0.3, 1.5) at Month 6 (N=97). Median (IQR) RAID score was 6.6 (5.0, 7.6) at baseline (N=142), 5.8 (4.1, 6.9) at Week 1 (N=300) and 3.9 (2.2, 6.0) at Month 6 (N=220). 618 patients (52.5%) had TEAEs on study, leading to treatment discontinuation in 91 (7.7%) cases. There were 6 deaths, 1 of which was considered related to study treatment (pneumonia and pulmonary embolism). TEAEs included COVID-19 (n=106), herpes zoster (n=16), fractures (n=20), opportunistic infections (n=3), stroke (n=6), transient ischemic attack (n=5), unstable angina (n=7), malignant/unspecified tumor (n=7) and pulmonary embolism (n=2).

Conclusion: Interim data from patients treated with filgotinib in routine practice show pain, fatigue, work productivity and RAID score improved as early as Week 1. DAS28-CRP, CDAI and HAQ-DI improved as early as Month 1, the first timepoint these endpoints were assessed. Improvements were maintained up to Month 18 (Month 6 for RAID and HAQ-DI). Longer-term follow-up and completion of the studies will allow further evaluation of effectiveness and safety.

Acknowledgements: We thank the physicians and patients who participated in this study. The study was funded by Galapagos NV (Mechelen, Belgium). Medical writing support was provided by Debbie Sherwood, BSc, CMPP (Aspire Scientific, Bollington, UK), and funded by Galapagos NV. Publication coordination was provided by Jo-Ann E. West, MSc, a consultant funded by Galapagos NV.

Disclosure of Interests: Jérôme Avouac AbbVie, AstraZeneca, Biogen, BMS, Eli Lilly, Fresenius Kabi, Galapagos, MSD, Novartis, Pfizer, Sandoz and Sanofi, AbbVie, Fresenius Kabi, Galapagos and Sanofi, BMS, Fresenius Kabi, Galapagos, Novartis and Pfizer, Gerd R. Burmester AbbVie, BMS, Eli Lilly, Galapagos, MSD and Pfizer, AbbVie, BMS, Eli Lilly, Galapagos, MSD and Pfizer, Roberto F. Caporali AbbVie, Amgen, BMS, Celltrion, Eli Lilly, Fresenius Kabi, Galapagos, Janssen, MSD, Novartis, Pfizer and UCB, AbbVie, Accord, Eli Lilly, Fresenius Kabi, Galapagos, Janssen, Novartis, Pfizer and UCB, Thomas P. A. Debray Biogen, Daiichi Sankyo, Galapagos and Gilead, Francesco De Leonardis Galapagos, Galapagos, James Galloway AbbVie, Eli Lilly, Galapagos, Janssen, Pfizer and UCB, AbbVie, Eli Lilly, Galapagos, Janssen and Pfizer, AstraZeneca, Janssen and Pfizer, Neil Betteridge Amgen, ASIF, Edwards Lifesciences, Eli Lilly, EULAR Global Alliance for Musculoskeletal Health, Global Alliance for Patient Access, Grünenthal, Heart Valve Voice, Pfizer and Sanofi Genzyme, Karen Bevers Galapagos, Susana Romero-Yuste AbbVie, Biogen, BMS, Eli Lilly and Pfizer, Eli Lilly and Sanofi, Eli Lilly and MSD, Monia Zignani Galapagos, Galapagos, Patrick Verschueren Eli Lilly and Galapagos, AbbVie, Eli Lilly and Galapagos, Galapagos and Pfizer.