Filgotinib Demonstrates Early, Durable PRO Improvements in RA

Rieke Alten, MD

Credit: X.com

Patients with rheumatoid arthritis (RA)receiving filgotinib had meaningful improvements in patient-reported outcomes (PROs), including pain and fatigue, which occurred early and were maintained over time, according to a post hoc analysis presented at the 2024 European Congress of Rheumatology (EULAR).¹

“The quality of life of patients with RA can be severely impacted by pain, fatigue and impaired physical functioning that can vary week-on-week,” wrote a team of investigators led by Rieke Alten, MD, head of the Department of Internal Medicine, Rheumatology, Clinical Immunology, Osteology at Schlosspark-Klinik, University Medicine Berlin, Germany. “Filgotinib has previously demonstrated early onset of improvement in these meaningful PROs at the group level. However, it is unknown what proportion of patients improved and whether these improvements are sustained at the individual level.”

The analysis used data from the phase 3 FINCH 1 and FINCH 2 trials to determine patient-level sustained improvement in predefined meaningful PROs among patients with RA treated with FIL 200 mg or FIL 100 mg (FIL 200/100), adalimumab, or placebo.

The FINCH 1 trial enrolled patients with RA with an inadequate response to methotrexate. These patients were randomized to receive either FIL 200/100, adalimumab, or placebo, with concomitant methotrexate, for 52 weeks. The FINCH 2 trial enrolled patients with an inadequate response to ≥ 1 biologic disease-modifying antirheumatic drug (bDMARD). Patients in this cohort received either FIL 200/100 or placebo, with concomitant conventional synthetic DMARDs (csDMARDs), for 24 weeks.

Investigators analyzed the proportions of patients who were able to achieve the following criteria:

• “Limited to no pain” status (visual analog scale [VAS] ≤ 10 mm)
• “Health status not negatively affected by pain (VAS ≤ 20 mm)
• Minimal clinically important difference (MCID) in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
• Change from baseline (CFB) ≥ 4
• Health Assessment Questionnaire-Disability Index (HAQ-DI) with the MCID, CFB equaling <-.22.

They also evaluated the proportion of patients achieving first response at weeks 2, 4, 12, 24, and 52 (week 52 data was only available in FINCH 1), as well as the duration of response among responders, and sustained response at weeks 24 and 52 for those receiving filgotinib. Proportions and duration of response were determined using Kaplan-Meier estimates.

Results revealed a greater proportion of patients in the FIL 200 group achieved a response for “limited to know pain,” “health status not negatively affected by pain,” and HAQ-DI in both trials compared with the FIL 100 and placebo groups. A greater proportion of the FIL 200 cohort achieved FACIT-Fatigue compared with placebo, although proportions were comparable with the FIL 100 cohort.

In the FINCH 1 trial, more patients receiving treatment first achieved “limited to no pain” status when compared with the placebo group. However, a higher proportion of patients receiving FIL 200 achieved these criteria when compared with FIL 100 or adalimumab groups at week 4 (12.2%, 7.1%, and 8.6%, respectively).

HAQ-DI response duration was comparable with the FIL 200/100 arms and lasted longer than the adalimumab and placebo groups. This response, which was measured up to 12 weeks post-response, was deemed stable. Other PRO responses were similar in both FINCH 1 and FINCH 2, with the exception of FACIT-Fatigue, which showed overlaps in the FIL 200/100 and adalimumab curves.

In the FIL 200 group, “limited to no pain” status was obtained by week 12 and sustained to week 52 in 15.4% of patients in FINCH 1 and to week 24 in 13.6% of patients in FINCH 2. Sustained “health status not negatively affected by pain,” FACIT-Fatigue, and HAQ-DI responses were observed in 29.7%, 49.3%, and 64.4% of patients in the FIL 200 group in FINCH 1 and 29.9%, 55.8%, and 63.9% in FINCH 2, respectively.

“These data help to strengthen the scientific understanding of the unique clinical and PRO benefits with filgotinib treatment relevant to patients,” wrote investigators.

References

1. ^{Alten R, Fautrel B, Conaghan PG, De Vries D, et al. Sustained Patient Meaningful Outcomes of Pain and Fatigue Relief and Improved Physical Functioning with Filgotinib in Rheumatoid Arthritis: A Post Hoc Analysis. Presented at: EULAR. Vienna, Austria. June 12 – 15, 2024.}