P112 The Impact of Filgotinib on Disease Activity Outcomes With Concomitant Pain Control in the Phase 3 FINCH Studies
Bibliographic record
Abstract
Abstract Background/Aims Patients with rheumatoid arthritis (RA) often experience substantial pain despite treatment, and consider pain control an important treatment outcome. This post-hoc analysis of the FINCH studies assessed specific effects of filgotinib (FIL) on pain and its relationship with efficacy in patients with RA. Methods FINCH 1-3 (NCT02889796, NCT02873936, NCT02886728) were Phase 3, randomized, double-blind trials of FIL 100 mg and 200 mg (FIL100/200). For each treatment group, patients reported pain on a 100-mm visual analog scale (VAS). VAS pain ≤20 mm indicated health status was not negatively affected by pain; ≤10 mm reflected limited to no pain. Time to first VAS pain ≤10 mm was assessed. The duration of the study period during which VAS pain was ≤20 mm or ≤ 10 mm and the proportion of patients who achieved remission at Week 24 was evaluated. Of patients who achieved DAS28-CRP or CDAI remission, the proportion who also reported VAS pain ≤20 mm or ≤ 10 mm was determined. Results In FINCH 1, there was a higher probability of achieving VAS pain ≤10 mm with FIL200, vs ADA + MTX or PBO + MTX; responses were better or comparable with FIL100 vs other treatments. Similar findings were seen in FINCH 2 and 3. In FINCH 1, the time during which VAS pain score was ≤20 mm or ≤ 10 mm was greatest in the FIL200 group (Table). The duration of time under each pain threshold was greater in each FIL group vs PBO in FINCH 2 (Table) and in each FIL group vs MTX in FINCH 3. The proportion of patients who achieved VAS pain ≤20 mm and ≤10 mm in addition to DAS28-CRP remission was 35.8% and 26.3%, respectively, in the FIL200 + MTX group, vs 24.6% and 17.2% in the ADA + MTX group. Findings were similar when CDAI remission was assessed for FINCH 1 and 2. Conclusion Across the studies, duration of threshold pain responses achieved over the observation periods was greater with FIL vs comparators. These findings suggest that JAK1 inhibition may offer potential added value with respect to patient-reported pain as well as treat-to-target goals. Disclosure P.C. Taylor: Consultancies; AbbVie, Biogen, Eli Lilly, Fersenius Kabi, Galapagos, Gilead, GSK, Janssen, Nordic Pharma, Sanofi, UCB. Grants/research support; P.T. has received funding for research from Galapagos. A. Kavanaugh: Consultancies; AbbVie, Amgen, BMS, Janssen, Novartis, Pfizer, UCB. P. Nash: Honoraria; AbbVie, BMS, Celgene, Eli Lilly, Galapagos, GSK, Janssen, Novartis, Pfizer. Grants/research support; AbbVie, BMS, Celgene, Eli Lilly, Galapagos, GSK, Janssen, Novartis, Pfizer. J. Pope: Consultancies; AbbVie. G. Pongratz: Consultancies; AbbVie, Boehringer Ingelheim, Galapagos, Eli Lilly, Pfizer, Roche. Honoraria; AbbVie, Boehringer Ingelheim, Eli Lilly, Pfizer, Roche, Sanofi. B. Fautrel: Consultancies; AbbVie, BMS, Chugai, Fersenius Kabi, Galapagos, Eli Lilly, Medac, Nordic Pharma, Novartis, Pfizer, Sobi, UCB. Grants/research support; AbbVie, Eli Lilly, Pfizer. R. Alten: Consultancies; AbbVie, Amgen, Biogen, BMS, Celltrion, Gilead, Janssen, Eli Lilly, Medac, MSD, Mylan, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Viatris. Honoraria; AbbVie, Amgen, Biogen, BMS, Celltrion, Gilead, Janssen, Eli Lilly, Medac, MSD, Mylan, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Viatris. K. Hasegawa: Shareholder/stock ownership; Gilead. Other; Employee of Gilead. S. Rao: Other; Employee of Gilead. D. De Vries: Shareholder/stock ownership; Galapagos. Other; Employee of Galapagos. P. Stiers: Shareholder/stock ownership; Galapagos. Other; Employee of Galapagos. C. Watson: Shareholder/stock ownership; Galapagos. Other; Employee of Galapagos. R. Westhovens: Consultancies; Celltrion, Galapagos, Gilead. Honoraria; Celltrion, Galapagos, Gilead.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.023 | 0.016 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.008 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.012 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".