P118 Patient-reported outcomes, disease activity and safety in UK patients with rheumatoid arthritis treated with filgotinib: up to six-month interim results from a prospective observational study (FILOSOPHY)
Authors: Kirkham Bruce , McKay Neil D , Pratt Arthur G , Barry Jane , Bouzid Ouafia , Debray Thomas P A , Bhat Smita , Robertson Lindsay , Galloway James 
Published: April 2024

Background/Aims

FILOSOPHY (NCT04871919), an ongoing, observational Phase 4 study, will assess the effectiveness and safety of filgotinib, a JAK1-preferential inhibitor, in patients with RA in a real-world setting in Europe. We report interim UK data.

Methods

FILOSOPHY will enroll approximately 1,500 adults with moderate-to-severe active RA, upon first exposure to filgotinib, prescribed according to the product label and local standard-of-care. DAS28-CRP and CDAI were assessed at baseline, Month one, three and six and pain (visual analog scale [VAS]) and FACIT-Fatigue score at baseline, Week one, two and three and Month one, three and six. A reduction of ≥ 10 mm in VAS pain or increase of ≥ 4 in FACIT-Fatigue score were considered a clinically meaningful change from baseline (CFB). Treatment-emergent adverse events (TEAEs) on study were reported.

Results

By January 31, 2023, 130 patients had been treated in the UK; baseline characteristics and study treatment are reported in the Table. Median (IQR) CFB in DAS28-CRP was -1.1 (-2.5, -0.5) at Month one (N = 29), -1.7 (-2.6, -1.2) at Month 3 (N = 32) and -2.5 (-3.2, -1.0) at Month six (N = 27). Median (IQR) CFB in CDAI was -15.0 (-26.0, -8.0) at Month one (N = 31), -17.0 (-27.0, -12.0) at Month three (N = 31) and -25.0 (-30.0, -16.0) at Month 6 (N = 30). The proportion of patients with a clinically meaningful CFB in FACIT-Fatigue score was 45.0% (n = 18/40) at Week 1 and 65.6% (n = 21/32) at Month six. For VAS pain, the proportions were 47.5% (n = 19/40) at Week 1 and 66.7% (n = 22/33) at Month six. Similar trends were seen in the monotherapy and combination groups. No unexpected TEAEs occurred. Six patients discontinued the study prematurely; there was one death (lobar pneumonia); none were lost to follow-up.

Conclusion

Interim UK data showed pain and fatigue improved with filgotinib treatment as early as Week one and disease activity as early as Month one, the first timepoint that DAS28-CRP and CDAI were assessed; improvements were maintained up to Month six. While conclusions regarding safety cannot be made due to the short follow-up and small sample size, no new safety findings were observed. Long-term follow-up is needed to further evaluate effectiveness and safety.

Disclosure

B. Kirkham: Consultancies; AbbVie, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, UCB. Member of speakers’ bureau; AbbVie, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, UCB. Grants/research support; Eli Lilly, Novartis. N.D. McKay: Consultancies; Gilead, UCB. Member of speakers’ bureau; Galapagos. Other; Registration for conference fees from AbbVie, Novartis, UCB. His department has received grants and payments from a wide range of pharmaceutical companies for research and education. A.G. Pratt: Consultancies; Inflection Biosciences (paid to Newcastle University). Grants/research support; Galapagos, GSK, Pfizer (paid to Newcastle University). J. Barry: Other; Employee of Galapagos. O. Bouzid: Consultancies; Galapagos. T.P.A. Debray: Consultancies; Biogen, Daiichi Sankyo, Galapagos, Gilead. S. Bhat: None. L. Robertson: Other; Financial support for conference attendance from UCB. J. Galloway: Consultancies; AbbVie, Galapagos, Janssen, Lilly, Pfizer. Honoraria; AbbVie, Galapagos, Janssen, Lilly, Pfizer, UCB. Member of speakers’ bureau; AbbVie, Galapagos, Janssen, Lilly, Pfizer, UCB. Grants/research support; AstraZeneca, Janssen, Pfizer.