Long-term Safety of Filgotinib in Patients with Psoriatic Arthritis, Week 52 Safety Data from a Phase 2 Open-Label Extension Study

Laura Coates¹, Philip Mease ², Dafna Gladman ³, Filip Van den Bosch ⁴, Anna Rychlewska-Hanczewska ⁵, Chantal Tasset ⁶, Luc Meuleners ⁶, Mona Trivedi ⁷, Jingjing Gao ⁷, Robin Besuyen ⁶ and Philip Helliwell ⁸, ¹University of Oxford, Oxford, United Kingdom, ²Swedish Medical Center/Providence St Joseph Health, and University of Washington, Seattle, WA, ³Toronto Western Hospital, Toronto, Canada, Toronto, ON, Canada, ⁴Ghent University Hospital, Ghent, Belgium, ⁵5ai centrum medyczne sp. z o.o. sp.k., Poznan, Poland, Poznan, Poland, ⁶Galapagos NV, Mechelen, Belgium, ⁷Gilead Sciences Inc, Foster City, United States of America, Foster City, CA, ⁸University of Leeds, Leeds, United Kingdom

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Janus kinase (JAK), OLE and filgotinib, Psoriatic arthritis

Session Information

Date: Monday, November 11, 2019

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Treatment of Axial Spondyloarthritis & Psoriatic Arthritis

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Filgotinib (FIL) is an orally administered, selective Janus Kinase 1 (JAK1) inhibitor in development for psoriatic arthritis (PsA). Efficacy and safety of FIL in patients with active PsA were evaluated in a 16-week phase 2 study (EQUATOR)¹. After 16 weeks, patients could roll-over to an Open Label Extension (OLE) Study (EQUATOR2) for the purpose of evaluating long-term safety and efficacy. The aim of this analysis was to assess safety and efficacy through 52 weeks of exposure to filgotinib.

Methods: Patients who completed the randomized, double-blind, placebo controlled study were eligible for participation in the OLE, during which all patients received once daily (qd) open-label FIL 200mg. In this interim analysis of OLE, for the safety analysis, all data were included from the screening in the core study up to the data cut of 18 April 2019 in the OLE. For the efficacy analysis, all data until OLE Week 52 visit (for each patient) were included (observed case analysis).

Results: Of the 131 pts randomized and dosed in EQUATOR, 124 (95%) completed the study and 122 (93%) enrolled in EQUATOR2; 50% were female and mean age was 50. At this interim analysis, 106/122 (87%) remained in the OLE (premature discontinuations during OLE due to: 4 for safety, 11 withdrew consent, and 1 for other reasons). Cumulative patient years of exposure (PYE) on FIL were 160, median time on FIL was 66 weeks. Key safety data are summarized in Table 1. Laboratory abnormalities are shown in Table 2. At week 52, 34% of the patients fulfilled criteria for minimal disease activity and 81%, 55%, and 33% of patients, respectively, achieved ACR20/50/70 responses.

Conclusion: FIL 200mg qd was generally well tolerated and the safety profile in PsA was comparable to that observed in the FIL rheumatoid arthritis studies. The data from this interim analysis suggest that further improvement of the patient condition can be expected beyond 16 weeks of treatment.

CL-225 table 1_key safety events

Table 1: Key safety events

CL-225 Table 2 key treatment-emergent lab abnormalities

Table 2: Key treatment-emergent lab abnormalities

Disclosure: L. Coates, Abbvie, 2, 5, 8, AbbVie, 2, 5, 8, AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Prothena, Sun Pharma, UCB, 5, Abbvie, Amgen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB, 5, Abbvie, Amgen, Lilly, Novartis, Pfizer, UCB, 8, AbbVie, Celgene Corporation, Eli Lilly, Janssen, Novartis, UCB, 8, AbbVie, Celgene Corporation, Eli Lilly, Novartis, Pfizer, 2, AbbVie, Celgene Corporation, Novartis, Pfizer, 2, Abbvie, Celgene, Novartis, Pfizer, Lilly, 2, Amgen, 5, 8, Biogen, 8, Bristol-Myers Squibb, 5, Celgene, 2, 5, 8, Eli Lilly, 2, 5, 8, Galapagos, 5, Gilead, 5, Janssen, 2, 5, 8, Janssen Research & Development, LLC, Lilly, 2, 5, 8, MSD, 5, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Pfizer Inc, 2, 5, 8, Prothena, 5, Sun Pharma, 5, UCB, 5, 8, UCB Pharma, 5; P. Mease, Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Genentech, Janssen, Novartis, Pfizer, Roche, UCB, 2, 5, Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB, 8, AbbVie, 2, 5, 8, Abbvie, 2, 5, 8, Abbvie, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 5, Abbvie, Amgen, Bristol Myers Squibb, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, 8, Abbvie, Amgen, Bristol Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 2, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Leo, Merck, Novartis, Pfizer and UCB., 5, 8, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, Inc., and UCB, 2, Abbvie, Amgen, Brsitol Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 5, Abbvie, Amgen, Brsitol Myers Squibb, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, 8, Abbvie, Amgen, Brsitol Myers Squibb,Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 2, Amgen, 2, 5, 6, 8, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Gilead, GSK, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, and UCB, 5, BMS, 2, 5, 8, Boehringer Ingelheim, 2, 5, Boerhinger Ingelheim, 5, Bristol Myers Squibb, 2, 5, 8, Bristol Myers Squibb Co., 2, 5, 8, Bristol-Myers Squibb, 2, 5, 6, 8, Celgene, 2, 5, 6, 8, Celgene Corp., 2, 5, 8, CORRONA, 5, Eli Lilly, 2, 5, 8, Galapagos, 2, 5, 8, Genentech, 2, 5, 6, 8, Gilead, 2, 5, 8, Janssen, 2, 5, 6, 8, Janssen Inc, 2, 5, 8, Leo, 2, 5, 8, Lilly, 2, 5, 6, 8, Merck, 2, 5, 8, Novartis, 2, 5, 6, 8, Pfizer, 2, 5, 8, Pfizer Inc, 2, 5, 6, Sun, 2, 5, SUN, 2, 5, Sun Pharma, 2, 5, Sun Pharmaceutical Industries, 2, 5, Sun Pharmaceutical Industries, Inc., 2, 5, 8, UCB, 2, 5, 6, 8, UCB Pharma, 2, 5, 8; D. Gladman, AbbVie, 2, 5, Amgen, 2, 5, BMS, 5, Celgene, 2, 5, Eli Lilly, 2, 5, Galapagos, 5, Galapagos NV, 5, Gilead, 5, GSI, 5, Janssen, 5, Janssen Research & Development, LLC, 2, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2, 5; F. Van den Bosch, AbbVie, 5, 8, Abbvie, 5, 8, AbbVie, Bristol-Myers Squibb, Celgene, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sanofi and UCB, 5, 8, ABBVIE, CELGENE, ELI LILLY, GALAPAGOS, MERCK, NOVARTIS, PFIZER, VCB, 5, 8, Bristol-Myers Squibb, 2, 5, 8, Celgene, 5, 8, Eli Lilly, 5, 8, Galapagos, 5, 8, Janssen, 5, 8, Merck, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Sanofi, 5, 8, UCB, 5, 8; A. Rychlewska-Hanczewska, None; C. Tasset, Galapagos, 1, 3, Galapagos NV, 3, 4; L. Meuleners, Galapagos NV, 3, 4; M. Trivedi, Gilead Sciences Inc, 1, 3; J. Gao, Gilead Sciences Inc, 1, 3; R. Besuyen, Galapagos NV, 3, 4; P. Helliwell, AbbVie, 2, 8, Amgen, 8, Celgen, 8, Celgene, 8, Galapagos, 8, Janssen, 2, Janssen Research & Development, LLC, 2, Novartis, 2, Pfizer, 8, Pfizer Inc, 8, UCB, 8.

To cite this abstract in AMA style:

Coates L, Mease P, Gladman D, Van den Bosch F, Rychlewska-Hanczewska A, Tasset C, Meuleners L, Trivedi M, Gao J, Besuyen R, Helliwell P. Long-term Safety of Filgotinib in Patients with Psoriatic Arthritis, Week 52 Safety Data from a Phase 2 Open-Label Extension Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/long-term-safety-of-filgotinib-in-patients-with-psoriatic-arthritis-week-52-safety-data-from-a-phase-2-open-label-extension-study/. Accessed .

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