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THU0198 (2020)
EFFICACY AND SAFETY OF FILGOTINIB FOR PATIENTS WITH RHEUMATOID ARTHRITIS WITH INADEQUATE RESPONSE TO METHOTREXATE: FINCH 1 52-WEEK RESULTS
B. Combe1, A. Kivitz2, Y. Tanaka3, D. Van der Heijde4, J. A. Simon-Campos5, H. S. B. Baraf6, U. Kumar7, F. Matzkies8, B. Bartok8, L. Ye8, Y. Guo8, C. Tasset9, J. Sundy8, A. Jahreis8, N. Mozaffarian10, R. B. M. Landewé11, S. C. Bae12, E. Keystone13, P. Nash14
1Univ Montpellier, Montpellier, France
2Altoona Ctr for Clinical Research, Duncansville, PA, United States of America
3Univ of Occupational and Environmental Health, Japan, Kitakyushu, Japan
4Leiden Univ Medical Ctr, Leiden, Netherlands
5Köhler & Milstein Research, Mérida, Mexico
6The Ctr for Rheumatology and Bone Research, Wheaton, MD, United States of America
7All India Institute of Medical Sciences, New Delhi, India
8Gilead Sciences, Inc, Foster City, CA, United States of America
9Galapagos NV, Mechelen, Belgium
10Ichnos Sciences, Paramus, NJ, United States of America
11Amsterdam Univ Medical Ctr, Amsterdam, Netherlands
12Hanyang Univ Hospital for Rheumatic Diseases, Seongdong-gu, Seoul, Korea, Rep. of (South Korea)
13Univ of Toronto, Mount Sinai Hospital, Toronto, Canada
14School of Medicine, Griffith Univ, Brisbane, QLD, Australia

Background: Filgotinib (FIL) is an oral, potent, selective JAK1 inhibitor. FINCH 1 (NCT02889796) assessed FIL efficacy and safety in patients (pts) with rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX-IR); primary outcome results at week (W)12 and W24 were previously reported. 1


Objectives: To present FINCH 1 W52 results.


Methods: This global, phase 3, double-blind, active- and placebo (PBO)-controlled study randomised MTX-IR pts with active RA on a background of stable MTX 3:3:2:3 to oral FIL 200 mg or FIL 100 mg once daily, subcutaneous adalimumab (ADA) 40 mg every 2W, or PBO up to W52; pts receiving PBO at W24 were rerandomised to FIL 100 or 200 mg. Efficacy was assessed from clinical, radiographic, and pt-reported outcomes; W52 comparisons were not adjusted for multiplicity. Safety endpoints included adverse events (AEs) and laboratory abnormalities.


Results: Of 1755 treated pts, 1417 received study drug through W52. The majority (81.8%) were female, mean (standard deviation [SD]) RA duration was 7.8 (7.6) years, and baseline mean (SD) DAS28(CRP) was 5.7 (0.9). FIL efficacy was sustained through W52; 54%, 43%, and 46% of pts receiving FIL 200 and 100 mg and ADA, respectively, had W52 DAS28(CRP) <2.6 (nominal p for FIL 200 vs ADA = 0.024) ( Figures 1–2 , Table 1 ). FIL safety profile through W52 was consistent with W24 data. AEs of interest were infrequent and balanced among treatments ( Table 2 ); 82 pts (4.7%) discontinued treatment due to AEs.

Efficacy outcomes at week 52

FIL 200 mg (n = 475 ) FIL 100 mg (n = 480 ) ADA (n = 325 )
ACR20/50/70, % 78/62/44 76/59/38 74/59/39
DAS28(CRP) ≤3.2, % 66 + 59 59
mTSS a 0.18 +++ 0.45 0.61
HAQ-DI b −0.93 + −0.85 −0.85
SF-36 PCS b 12.0 11.5 12.4
FACIT-F b 11.9 12.2 11.7

a Least squares mean change from baseline.

b Mean change from baseline.

+ p <0.05, +++ p <0.001 vs ADA; not adjusted for multiplicity.

ADA, adalimumab; FIL, filgotinib; mTSS, modified van der Heijde TSS.

Treatment-emergent AEs through week 52

Event, n (% ) FIL 200 (n = 475 ) FIL 100 mg (n = 480 ) ADA (n = 325 )
All AEs 352 (74.1) 350 (72.9) 239 (73.5)
Serious AEs 35 (7.4) 40 (8.3) 22 (6.8)
Infection 206 (43.4) 194 (40.4) 129 (39.7)
Serious infection 13 (2.7) 13 (2.7) 10 (3.1)
Herpes zoster 6 (1.3) 4 (0.8) 2 (0.6)
VTE 1 (0.2) 0 1 (0.3)
MACE (adjudicated) 0 2 (0.4) 1 (0.3)
Malignancy (excluding NMSC) 2 (0.4) 2 (0.4) 2 (0.6)
NMSC 1 (0.2) 1 (0.2) 0
Death 3 (0.6) 1 (0.2) 1 (0.3)

Data omitted for patients rerandomised from placebo to FIL.

ADA, adalimumab; AE, adverse event; FIL, filgotinib; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; VTE, venous thromboembolism.


Conclusion: Through W52, both FIL 200 and 100 mg showed sustained efficacy based on clinical and pt-reported outcomes and radiographic progression and were well tolerated in MTX-IR pts with RA, with faster onset and numerically greater efficacy for FIL 200 vs 100 mg.


REFERENCES:

[1]Combe et al., Ann Rheum Dis. 2019; 78 (Suppl 2):77–8.


Disclosure of Interests: Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Alan Kivitz Shareholder of: AbbVie, Amgen, Gilead, GSK, Pfizer Inc, Sanofi, Consultant of: AbbVie, Boehringer Ingelheim,,Flexion, Genzyme, Gilead, Janssen, Novartis, Pfizer Inc, Regeneron, Sanofi, SUN Pharma Advanced Research, UCB, Paid instructor for: Celgene, Genzyme, Horizon, Merck, Novartis, Pfizer, Regeneron, Sanofi, Speakers bureau: AbbVie, Celgene, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer Inc, Regeneron, Sanofi, Yoshiya Tanaka Grant/research support from: Asahi-kasei, Astellas, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Pfizer, and Ono, Consultant of: Abbvie, Astellas, Bristol-Myers Squibb, Eli Lilly, Pfizer, Speakers bureau: Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Sanofi, UCB, and Teijin, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, J-Abraham Simon-Campos: None declared, Herbert S.B. Baraf Grant/research support from: Horizon; Gilead Sciences, Inc.; Pfizer; Janssen; AbbVie, Consultant of: Horizon; Gilead Sciences, Inc.; Merck; AbbVie, Speakers bureau: Horizon, Uma Kumar: None declared, Franziska Matzkies Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Beatrix Bartok Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Lei Ye Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Ying Guo Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Chantal Tasset Shareholder of: Galapagos (share/warrant holder), Employee of: Galapagos, John Sundy Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Angelika Jahreis Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Neelufar Mozaffarian Shareholder of: Gilead, Employee of: Gilead, Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Sang-Cheol Bae: None declared, Edward Keystone Grant/research support from: AbbVie; Amgen; Gilead Sciences, Inc; Lilly Pharmaceuticals; Merck; Pfizer Pharmaceuticals; PuraPharm; Sanofi, Consultant of: AbbVie; Amgen; AstraZeneca Pharma; Bristol-Myers Squibb Company; Celltrion; F. Hoffman-La Roche Ltd.; Genentech, Inc; Gilead Sciences, Inc.; Janssen, Inc; Lilly Pharmaceuticals; Merck; Myriad Autoimmune; Pfizer Pharmaceuticals, Sandoz, Sanofi-Genzyme, Samsung Bioepsis., Speakers bureau: AbbVie; Amgen; Bristol-Myers Squibb; Celltrion; F. Hoffman-La Roche Ltd, Janssen, Inc; Merck; Pfizer Pharmaceuticals; Sanofi-Genzyme; UCB, Peter Nash Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB

Citation: Ann Rheum Dis, volume 79, supplement 1, year 2020, page 316
Session: Rheumatoid arthritis - non biologic treatment and small molecules (Poster Presentations)