scholarly journals P133 Filgotinib in patients with RA with inadequate response to methotrexate: FINCH 1 52-week efficacy and patient reported outcomes data

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
David Walker ◽  
Alan Kivitz ◽  
Yoshiya Tanaka ◽  
Susan Lee ◽  
Lei Ye ◽  
...  
Keyword(s):  
Short Form ◽  
Pain Scale ◽  
Janus Kinase ◽  
Controlled Study ◽  
Stock Ownership ◽  
Inadequate Response ◽  
Research Support ◽  
Double Blind ◽  
Sf 36 ◽  
Patient Reported

Abstract Background/Aims  Filgotinib (FIL) is an oral, potent, selective Janus kinase 1 (JAK1) inhibitor. FINCH 1 (NCT02889796) assessed FIL efficacy, safety and patient reported outcome (PRO) data in patients (pts) with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX-IR). We report data through week 52 (W52) of the FINCH 1 study. Primary outcome results at week (W)12 and W24 were previously reported. 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 re-randomised to FIL 100 or 200 mg. Efficacy was assessed using clinical, radiographic, and pt-reported outcomes; W52 comparisons were not adjusted for multiplicity, and nominal p-values are reported. Safety endpoints included types and rates of adverse events (AEs) and laboratory abnormalities. PRO assessment included the HAQ-DI and VAS pain scale, SF-36, and FACIT-Fatigue questionnaire. Change from baseline (CFB) at various time points was assessed up to W52 for each treatment group. Results  Of 1,755 treated pts, 1,417 received study drug through W52. FIL efficacy was sustained through W52 with DAS28(CRP) <2.6 remission rates of 54%, 43%, and 46% of pts receiving FIL 200 and 100 mg and ADA, respectively, (nominal p for FIL 200 vs ADA = 0.024) (Table 1). FIL safety profile through W52 was consistent with W24 data. AEs of interest were infrequent and balanced among treatments. As early as W2, through W24, pts receiving either dose of FIL experienced nominally significantly greater (p < 0.001) CFB in HAQ-DI and VAS pain scale than those receiving PBO. These improvements were sustained up to W52. In general, CFB for HAQ-DI, VAS pain scale, and FACIT-Fatigue observed for the FIL groups was higher or comparable to ADA through W52 (Table 1). P133 Table 1:Efficacy and PRO outcomes at Week 52Efficacy OutcomeFIL 200 mg (n = 475)FIL 100 mg (n = 480)ADA (n = 325)ACR20/50/70, %a78/62/4476/59/3874/59/39DAS28(CRP) ≤3.2, %a66+5959mTSSb,c0.18+++0.450.61HAQ-DIc,d−0.93+−0.85−0.85VAS pain scalec,d−42−40−40SF-36 PCSc,d12.011.512.4FACIT-Fc,d11.912.211.7aNon-responder imputation,bLeast squares mean change from baseline,cObserved case,dMean change from baseline.+nominal p < 0.05, +++nominal p < 0.001 vs ADA ADA, adalimumab; FACIT-F, Functional Assessment of Chronic Illness Therapy Fatigue; FIL, filgotinib; HAQ-DI, Health Assessment Questionnaire-Disability Index; mTSS, modified van der Heijde TSS; SF-36, 36-Item Short Form Survey. Conclusion  Through W52, both FIL 200 and 100 mg showed sustained efficacy, rapid and sustained improvement in patient QoL based on clinical and pt-reported outcomes and were well tolerated in MTX-IR pts with RA. Disclosure  D. Walker: Consultancies; Lilly, Pfizer, Novartis, Roche. A. Kivitz: Consultancies; AbbVie, Boehringer Ingelheim, Flexion, Janssen, Pfizer, Sanofi, Regeneron, SUN Pharma Advanced Research, Gilead Sciences, Inc. Shareholder/stock ownership; Pfizer, Sanofi, GlaxoSmithKline, Gilead Sciences, Inc., Novartis. Member of speakers’ bureau; Celgene, Merck, Lilly, Novartis, Pfizer, Sanofi, Genzyme, Flexion, AbbVie. Y. Tanaka: Honoraria; AbbVie, Asahi Kasei, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead Sciences, Inc., GlaxoSmithKline, Janssen, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Sanofi and Y. Grants/research support; AbbVie, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Takeda and UCB. S. Lee: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. L. Ye: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. H. Hu: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. F. Matzkies: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. B. Bartok: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. B. Bartok: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. Y. Guo: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. J.S. Sundy: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. A. Jahreis: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. R. Besuyen: Shareholder/stock ownership; Galapagos BV. Other; Employee of Galapagos BV. B. Combe: Other; Reports research support, honoraria, consulting and speaker fees from AbbVie; Bristol-Myers Squibb; Eli Lilly & Co.; Gilead Sciences, Inc.; Janssen; Novartis; Pfizer; Roche-Chugai; Sanofi; and UCB. D. van der Heijde: Consultancies; AbbVie; Amgen; Astellas; AstraZeneca; Bristol-Myers Squibb; Boehringer Ingelheim; Celgene; Cyxone; Daiichi-Sankyo; Eisai; Eli Lilly & Co.; Galapagos; Gilead Sciences, Inc.; Glaxo-Smith-Kline; Janssen;, Merck; Novartis; Pfizer; Regeneron; Roche; Sanofi; Takeda; and UCB. J. Simon-Campos: None. H.S.B. Baraf: Grants/research support; AbbVie; Horizon; Gilead Sciences, Inc.; Pfizer; Janssen; and Merck. U. Kumar: None. C. Tasset: Shareholder/stock ownership; Galapagos NV. Other; Employee of Galapagos NV. N. Mozaffarian: Shareholder/stock ownership; Gilead Sciences, Inc. Other; Employee of Gilead Sciences, Inc. R.B.M. Landewé: Consultancies; AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Gilead Sciences, Inc.; Galapagos NV; Novartis; Pfizer; and UCB. S. Bae: None. E. Keystone: Other; Reports research support, consulting, and speaker fees from AbbVie; Amgen; AstraZeneca; Bristol-Myers Squibb; Celltrion; F. Hoffman-La Roche Ltd.; Genentech, Inc; Gilead Sciences, Inc.; Janssen; Lilly, ; Merck; Myriad Autoimmune; Pfizer; PuraPharm; Sandoz; Sanofi-Genzyme; Samsung Bioepsis; and UCB. P. Nash: Other; Reports research support, consulting, and speaker and personal fees from AbbVie; Bristol-Myers Squibb; Celgene; Eli Lilly & Co.; Gilead Sciences, Inc; Janssen; Merck Sharp & Dohme; Novartis; Pfizer;, Roche; Sanofi; and UCB.

scholarly journals P210 Efficacy and safety of filgotinib for patients with RA with inadequate response to methotrexate: FINCH1 primary outcome results

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
David Walker ◽  
Bernard G Combe ◽  
Alan J Kivitiz ◽  
Yoshiya Tanaka ◽  
Désirée van der Heijde ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Study Drug ◽  
Janus Kinase ◽  
Controlled Study ◽  
Stock Ownership ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Mixed Effect ◽  
Patient Reported

Abstract Background Filgotinib (FIL) is an oral, potent, selective Janus kinase 1 inhibitor that has shown good efficacy and was well tolerated for treatment of rheumatoid arthritis (RA). The objective of this study was to evaluate efficacy and safety of FIL treatment in patients with RA who have had an inadequate response to methotrexate (MTX). Methods This Phase 3, double-blind, active- and placebo (PBO)-controlled study randomised patients with active RA (3:3:2:3) to FIL 200mg, FIL 100mg, adalimumab [ADA] 40mg every 2 weeks, or PBO daily for up to 52 weeks; results through week 24 are presented. Patients also received background MTX. Primary efficacy endpoint was proportion of patients achieving ACR20 at week 12; additional clinical assessments included ACR50 and ACR70 and DAS28-CRP score ≤3.2 and <2.6, and patient-reported outcomes including HAQ-DI. Safety endpoints included adverse event types and rates. Logistic regression was used for superiority test of FIL vs PBO for ACR response and other binary endpoints, while mixed-effect model for repeated measures (MMRM) were used for continuous endpoints. Non-inferiority test of FIL to ADA (preserving >50% of ADA response) was performed for DAS28-CRP ≤3.2 and <2.6. Results Of 1,759 patients randomised, 1,755 received study drug: 475 FIL 200mg; 480 FIL 100mg; 325 ADA; and 475 PBO, of which 89.5%, 90.4%, 88.9%, and 81.3%, respectively, completed 24 weeks of study drug. 81.8% were female, mean (standard deviation [SD]) duration of RA was 7.8 (7.6) years, and mean (SD) DAS28-CRP was 5.7 (0.9). At week 12, significantly more patients in the FIL 200mg and 100mg arms achieved an ACR20 improvement vs PBO (Table 1). More patients receiving FIL achieved ACR50 and ACR70 improvements, DAS28-CRP scores ≤3.2 and <2.6 and reported improvements in HAQ-DI scores versus PBO (Table 1). Non-inferiority of FIL 200mg to ADA was met based on DAS28-CRP ≤3.2. The FIL safety profile was consistent with prior studies through Week 24. Conclusion FIL 200mg and 100mg led to significant improvement in signs and symptoms of RA, prevented radiographic progression, improved physical function compared to PBO, and was well-tolerated. Efficacy of FIL 200mg was non-inferior to ADA based on DAS28-CRP ≤3.2. Disclosures D. Walker: Other; Received support from Lilly, Pfizer, Novartis and Roche. B.G. Combe: Honoraria; Received honoraria from AbbVie, BMS, Gilead, Janssen, Eli Lilly and Co., MSD, Novartis, Pfizer, Roche-Chugai, Sanofi and UCB. A.J. Kivitiz: Consultancies; Consultant to AbbVie, Celgene, Horizon, Jansses, Merck, Novartis, Pfizer, UCB, Genzyme, Sanofi, Regeneron, SUN Pharma Advanced Research, Boehringer Ingelheim, Flexion and Novartis. Shareholder/stock ownership; Shareholder of Novartis. Y. Tanaka: Honoraria; Honoraria from Daiichi-Sankyo, Astellas, Chugai, Eli Lilly ans Co., Pfizer, AbbVie, YL Biologics, BMS, Takeda, Misubishi-Tanabe, Novartis, Eisai, Janssen, Teijin. Grants/research support; Grant support from Asahi-Kasei, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, BMS, UCB, Daiichi-Sankyo, Eisai, Ono, Astellas, Eli Lilly, Pfizer, Abbvi and YL. D. van der Heijde: Corporate appointments; Director of Imaging Rheumatology bv. Consultancies; Consultant for consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and UCB. F. Matzkies: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. B. Bartok: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. L. Ye: Corporate appointments; Employee of Gilead Sciences, Inc.. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Y. Guo: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. C. Tasset: Corporate appointments; Employee of Galapagos NV. J.S. Sundy: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. N. Mozaffarian: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. R.B.M. Landewé: Consultancies; Consultant for AbbVie, AstraZeneca, BMS, Galapagos, Pfizer, Eli Lilly, Novartis, and UCB.. S. Bae: None. E.C. Keystone: Consultancies; Consultant for AbbVie, Amgen, AstraZeneca Pharma, Biotest, BMS Canada, Celltrion, Crescendo, Bioscience, F.Hoffman-La Roche Inc., Genentech, Janssen, Eli Lilly and Co., Merck, Pfizer,, PuraPharm, Sandoz, Sanofi-Aventis, Sanofi-Genzyme, Samsumg Bioepsis, and UCB. P. Nash: Consultancies; Consultant for AbbVie, BMS, Jansses, Pfizer, Roche, Lilly, Sanofi, MSD, Novartis, Celgene and Gilead.

scholarly journals Improved pain, physical functioning and health status in patients with rheumatoid arthritis treated with CP-690,550, an orally active Janus kinase (JAK) inhibitor: results from a randomised, double-blind, placebo-controlled trial

2009 ◽  
Vol 69 (2) ◽  
pp. 413-416 ◽  
Author(s):  
J H Coombs ◽  
B J Bloom ◽  
F C Breedveld ◽  
M P Fletcher ◽  
D Gruben ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Health Status ◽  
Short Form ◽  
Controlled Trial ◽  
Health Assessment ◽  
Janus Kinase ◽  
Inadequate Response ◽  
Double Blind ◽  
Sf 36 ◽  
Factor Α

Objectives:To determine the efficacy of CP-690,550 in improving pain, function and health status in patients with moderate to severe active rheumatoid arthritis (RA) and an inadequate response to methotrexate or a tumour necrosis factor α inhibitor.Methods:Patients were randomised equally to placebo, CP-690,550 5, 15 or 30 mg twice daily for 6 weeks, with 6 weeks’ follow-up. The patient’s assessment of arthritis pain (pain), patient’s assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 (SF-36) were recorded.Results:At week 6, significantly more patients in the CP-690,550 5, 15 and 30 mg twice-daily groups experienced a 50% improvement in pain compared with placebo (44%, 66%, 78% and 14%, respectively), clinically meaningful reductions in HAQ-DI (⩾0.3 units) (57%, 75%, 76% and 36%, respectively) and clinically meaningful improvements in SF-36 domains and physical and mental components.Conclusions:CP-690,550 was efficacious in improving the pain, function and health status of patients with RA, from week 1 to week 6.

scholarly journals P284 Certolizumab pegol-treated patients with non-radiographic axSpA demonstrate improvements in sleep quality and other patient reported outcomes

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Raj Sengupta ◽  
Lianne Gensler ◽  
Jonathan Kay ◽  
Walter Maksymowych ◽  
Nigil Haroon ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Patient Reported Outcomes ◽  
Sleep Problems ◽  
Certolizumab Pegol ◽  
Spinal Pain ◽  
Controlled Study ◽  
Inadequate Response ◽  
Research Support ◽  
Double Blind ◽  
Patient Reported

Abstract Background Certolizumab pegol (CZP) treatment has demonstrated improvements in multiple manifestations of non-radiographic axial spondyloarthritis (nr-axSpA), including patient-reported outcomes (PROs). Here, we report PROs for nr-axSpA patients treated with CZP or placebo in CaxSpAnd - the first 52-week placebo-controlled study to investigate the efficacy of an anti-TNF agent in patients with active nr-axSpA and objective signs of inflammation. Methods C-axSpAnd (NCT02552212) is a 3-year, phase 3, multicenter study including a 52-week double-blind, placebo-controlled period (completed); patients who had an inadequate response to ≥ 2 non-steroidal anti-inflammatory drugs were randomized 1:1 to placebo or CZP (400mg at Weeks 0/2/4, then 200mg every 2 weeks). Clinical PROs included: Sleep Problems Index scores I (6 items) and II (9 items) from the Medical Outcomes Study Sleep Scale (assesses sleep disturbance, adequacy, somnolence, quantity, snoring, and awakening short of breath or with a headache), nocturnal spinal pain (numerical rating scale [NRS]), fatigue (BASDAI Q1), and morning stiffness (average of BASDAI Q5 + 6). Post-hoc analyses of minimal clinically important differences (MCID [≥1-point improvement]) for fatigue and nocturnal spinal pain were conducted. Variables were analyzed using an ANCOVA model including baseline score as a covariate and fixed effects for treatment group, region and MRI/CRP classification. P-values were nominal. Missing values following discontinuation of double-blind treatment were imputed using last observation carried forward. Results 317 patients with nr-axSpA were randomised to CZP (n = 159) or placebo (n = 158); 125 (79%) and 54 (34%) patients, respectively, completed Week 52. CZP-treated patients showed greater improvements (indicated by higher scores) in Sleep Problems Index II scores vs placebo-treated patients at Week 12 (mean change from baseline: 4.8 [CZP] vs 2.2 [placebo]; p < 0.001). Improvements were also seen in other clinical PROs (Table). By Week 12, greater proportions of patients treated with CZP vs placebo experienced at least MCID response in fatigue (85.4% vs 57.6%, respectively) and nocturnal spinal pain (82.8% vs 58.9%, respectively); results were sustained through Week 52. Conclusion CZP-treated nr-axSpA patients showed substantial improvements in sleep quality and other clinical outcomes important to patients; future analyses of these data will explore associations between sleep quality and other clinical PROs. Disclosures R. Sengupta: Other; R.S. has received speaker fees, support for conference attendance and grants from Abbvie, Biogen, Celgene, Novartis, Pfizer and UCB Pharma. L. Gensler: Grants/research support; AbbVie, Amgen, Novartis, UCB Pharma; consulting fees from Galapagos, Eli Lilly and Janssen. J. Kay: Consultancies; AbbVie, Boehringer Ingelheim, Celltrion Healthcare, Horizon Therapeutics, Merck Sharp & Dohme, MorphoSys, Novartis, Pfizer, Samsung Bioepis, Sandoz and UCB Pharma. Grants/research support; Gilead Sciences, Novartis AG, Pfizer and UCB Pharma. W. Maksymowych: Other; Consultant and/or speaker fees and/or grants from AbbVie, Amgen, Eli Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma. N. Haroon: Consultancies; Abbvie, Amgen, Eli Lilly, Janssen, Novartis and UCB Pharma. L. Bauer: Other; Employee of UCB Pharma. B. Hoepken: Other; Employee of UCB Pharma. N. de Peyrecave: Other; Employee of UCB Pharma. T. Kumke: Other; Employee of UCB Pharma. A. Deodhar: Consultancies; AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith and Klein, Janssen, Novartis, Pfizer and UCB. Grants/research support; BMS, Eli Lilly, Glaxo Smith & Kline, Janssen, Novartis, Pfizer and UCB.

scholarly journals P217 Efficacy and safety of filgotinib for patients with RA naïve to MTX therapy: FINCH3 primary outcome results

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Neil McKay ◽  
Désirée van der Heijde ◽  
Rene Westhovens ◽  
William F. C Rigby ◽  
Daniel W. T Ching ◽  
...  
Keyword(s):  
Study Drug ◽  
Signs And Symptoms ◽  
Janus Kinase ◽  
Controlled Study ◽  
Stock Ownership ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acr20 Response ◽  
Patient Reported ◽  
Oral Steroids

Abstract Background Filgotinib (FIL), an orally administered, potent, selective inhibitor of janus kinase 1 (JAK1), has shown good efficacy and was well tolerated for treatment of rheumatoid arthritis (RA). The objectives of this study were to compare efficacy and safety of FIL with and without methotrexate (MTX) in patients with RA who were naïve to MTX therapy. Methods This Phase 3, double-blind, active-controlled study randomised patients with moderately to severely active RA (2:1:1:2) to FIL 200mg daily+MTX, FIL 100mg+MTX, FIL 200mg (+placebo [PBO]), or MTX (+PBO) up to 52 weeks; results are through week 24. Primary endpoint was proportion achieving ACR20 response at week 24. Safety endpoints included adverse events types and rates. Results Of 1,252 randomised patients, 1,249 received study drug (416 FIL 200mg+MTX; 207 FIL 100mg+MTX; 210 FIL 200mg monotherapy; 416 MTX monotherapy) and were analysed; 1,130 completed week 24. Most (76.9%) were female; mean time since RA diagnosis was 2.2 years (median 0.4 years); mean (standard deviation [SD]) DAS28-CRP was 5.7 (1.0); and 35.9% were using oral steroids at baseline. At week 24, significantly more patients in the FIL 200mg+MTX (81.0%; P<0.001) and FIL 100mg+MTX (80.2%; P<0.05) arms achieved an ACR20 response compared to MTX monotherapy (71.4%)(Table 1). Compared to MTX monotherapy, more patients receiving FIL with or without MTX achieved ACR50 and ACR70 responses, DAS28-CRP <2.6 and ≤3.2, and reported improvements in SF-36 PCS (Table 1). The onset of activity was rapid, with significantly more patients achieving ACR50 and DAS28-CRP <2.6 with FIL than MTX at week 2. The FIL safety profile was consistent with prior studies through week 24. Serious AEs were observed in 4.1%, 2.4%, 4.8%, and 2.9% of patients in the FIL 200mg+MTX, FIL 100mg+MTX, FIL 200mg monotherapy, and MTX monotherapy groups, respectively. There was 1 death from lupus cardiomyopathy. Conclusion The JAK1 inhibitor FIL in combination with MTX led to significant improvements in RA signs and symptoms, physical function, and patient-reported outcomes compared to MTX alone and was well tolerated in patients with early active RA naïve to MTX. Clinically meaningful response to FIL occurred as early as 2 weeks after treatment initiation. Disclosures N. McKay: None. D. van der Heijde: Corporate appointments; Director of Imaging Rheumatology bv. Consultancies; Consultant for AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda Pharmaceutical Company Ltd., UCB. R. Westhovens: Corporate appointments; Advisor for Celltrion and Galapagos/Gilead. Other; Advisor for Celltrion and Galapagos/Gilead. W.F.C. Rigby: Consultancies; Consultant for Gilead. D.W.T. Ching: Corporate appointments; Speaker for AbbVie. Member of speakers’ bureau; Speaker for AbbVie. B. Bartok: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. F. Matzkies: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Z. Yin: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Y. Guo: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. C. Tasset: Corporate appointments; Employee of Galapagos NV. J.S. Sundy: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. N. Mozaffarian: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. O.D. Messina: Honoraria; Received Honoraria from Pfizer, Amgen, and Americas Health Foundation (AHF). R.B.M. Landewé: Consultancies; Consultant for AbbVie, AstraZeneca, BMS, Galapagos, Pfizer, Eli Lilly, Novartis, and UCB. T. Atsumi: None. G.R. Burmester: Honoraria; Received Honoraria from AbbVie, Gilead, Eli Lilly, and Pfizer.

scholarly journals P128 A subgroup analysis of the efficacy of filgotinib for patients with moderately active RA following an inadequate response to methotrexate

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Maya H Buch ◽  
David Walker ◽  
Patrick D W Kiely ◽  
Christopher J Edwards ◽  
Jane Barry ◽  
...  
Keyword(s):  
Disease Activity ◽  
Short Form ◽  
Health Assessment ◽  
Physical Component Score ◽  
Inadequate Response ◽  
Research Support ◽  
Reactive Protein ◽  
American College Of Rheumatology ◽  
Moderate Disease ◽  
Sf 36

Abstract Background/Aims  Filgotinib is an oral, preferential janus kinase 1 inhibitor. FINCH 1 (NCT02889796) was a phase III, double-blind, placebo- and active-controlled study evaluating filgotinib efficacy and safety in patients with rheumatoid arthritis (RA) after inadequate response to methotrexate (MTX; MTX-IR). Methods  MTX-IR patients with moderately or severely active RA were randomised (3:3:2:3) to filgotinib 200 mg daily, filgotinib 100 mg daily, adalimumab 40 mg every 2 weeks, or placebo on a background of stable MTX for up to 52 weeks. An exploratory subgroup analysis of FINCH 1 was conducted in patients with moderately active RA based on Disease Activity Score in 28 joints with C-reactive protein (DAS28[CRP])>3.2-≤5.1 at baseline. Proportion of patients achieving 20%/50%/70% improvement from baseline in American College of Rheumatology core criteria (ACR20/50/70), DAS28(CRP)≤3.2, DAS28(CRP)<2.6, change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 Physical Component Score (SF-36 PCS), patient-reported pain, and modified total Sharp/van der Heijde score (mTSS) were assessed at week (W)12 and W24. All analyses were exploratory without multiplicity adjustment; nominal P-values are reported. Results  Of 1,755 treated patients, 24% had moderate disease at baseline with similar proportions (21.9%-26.9%) across treatment groups. In each treatment arm, baseline characteristics were well balanced for the moderate disease activity subpopulation. The majority (77%) were female, mean (standard deviation [SD]) duration of RA was 7.8 (7.7) years; mean (SD) baseline DAS28(CRP) was 4.6 (0.42). At W12 and W24, proportions achieving ACR20/50/70, DAS28(CRP)<2.6, and DAS28(CRP)≤3.2 were significantly higher for both filgotinib doses relative to placebo (Table). Improvement in HAQ-DI was significantly greater vs placebo at W12 but not W24 for both filgotinib doses (Table 1). For both doses of filgotinib vs placebo, SF-36 PCS and pain were significantly improved and there was numerically less radiographic progression as assessed by mTSS at W12 and W24 (Table). Composite disease activity, HAQ-DI, and mTSS scores with both filgotinib doses were comparable to adalimumab. P128 Table 1:Efficacy outcomes at week 12 and week 24Week 12Week 24FIL 200 mg (n = 104)FIL 100 mg (n = 121)ADA (n = 72)PBO (n = 128)FIL 200 mg (n = 104)FIL 100 mg (n = 121)ADA (n = 72)PBO (n = 128)ACR2077.9***67.8***65.343.872.1**75.2***68.154.7ACR5043.3***37.2***41.716.452.9***47.1**56.930.5ACR7019.2***17.4***15.33.932.7***29.8**29.213.3DAS28 (CRP)<2.647.1***37.2***44.415.661.5***46.3***50.023.4DAS28 (CRP)≤3.267.3***63.6***66.739.174.0***73.6***62.549.2ΔHAQ-DI−0.51a,***−0.40b,*−0.47c−0.28d−0.57e−0.53f−0.65g−0.48hΔmTSS0.02i0.06j0.03k0.16l−0.04m,*0.11n−0.01o0.21pΔSF-36 PCS7.8q,***6.4r,***7.0s3.7t8.8u,**7.2v,*9.5w5.8xΔPain, mm−24***−23***−23−12−28***−28***−28−21***P<0.001 vs PBO;**P<0.01 vs PBO;*P<0.05 vs PBO; all P-values are nominal. Binary efficacy endpoints were compared between FIL and PBO using Fisher's exact test. Comparisons of change from baseline between FIL vs PBO were conducted using mixed-effects models for repeated measures including treatment group, visit, treatment group by visit, baseline value as fixed effects, and subjects as random effect.an = 98;bn = 114;cn = 67;dn = 117;en = 89;fn = 108;gn = 61;hn = 100;in = 94;jn = 113;kn = 62;ln = 112;mn = 89;nn = 105;on = 60;pn = 97;qn = 99;rn = 116;sn = 67;tn = 118;un = 91;vn = 109;wn = 62;xn = 100.ΔHAQ-DI, change from baseline in Health Assessment Questionnaire-Disability Index; ΔmTSS, change from baseline in modified total Sharp/van der Heijde score; ΔSF-36 PCS, change from baseline in Short Form-36 Physical Component Score; ACR, American College of Rheumatology; ADA, adalimumab; DAS28(CRP), Disease Activity Score in 28 joints with C-reactive protein; FIL, filgotinib; PBO, placebo. Conclusion  In a subgroup of patients from FINCH 1 with baseline moderately active RA, significantly greater improvements in disease activity were observed with both filgotinib doses over placebo and associated with lower radiographic progression and reduced functional deficit. Disclosure  M.H. Buch: Consultancies; MHB reports serving as a consultant for AbbVie; Eli Lilly; Gilead Sciences, Inc.; Sandoz; Sanofi; and Serono. Grants/research support; MHB reports grants or research support from Pfizer, Roche, and UCB. D. Walker: Grants/research support; DW has received funding from Bristol-Myers Squibb; Eli Lilly; Gilead Sciences, Inc.; Novartis; and Pfizer, Inc. P.D.W. Kiely: Other; PK has attended advisory boards, been part of a speakers bureau, or received support to attend educational meetings from AbbVie, Gilead, Lilly, Novartis, and Sanofi. C.J. Edwards: Consultancies; CJE has provided consultancy for AbbVie; Biogen; Bristol-Myers Squibb; Celgene; Eli Lilly; Fresenius; Gilead Sciences, Inc.; GSK; Janssen; MSD; Mundipharma; Pfizer; Roche; Samsung; and Sanofi. Member of speakers’ bureau; CJE has served on speaker's bureaus for AbbVie; Biogen; Bristol-Myers Squibb; Celgene; Eli Lilly; Fresenius; Gilead Sciences, Inc.; GSK; Janssen; MSD; Mundipharma; Pfizer; Roche; Samsung; and Sanofi. Grants/research support; CJE reports grants from AbbVie; Biogen; Bristol-Myers Squibb; Celgene; Eli Lilly; Fresenius; Gilead Sciences, Inc.; GSK; Janssen; MSD; Mundipharma; Pfizer; Roche; Samsung; and Sanofi. J. Barry: Corporate appointments; JB is an employee of Gilead Sciences Ltd. G. McCaughey: Corporate appointments; GMcC is an employee of Gilead Sciences Ltd. L. Akroyd: Corporate appointments; LA is an employee of Gilead Sciences Ltd. I. Tiamiyu: Corporate appointments; IT is an employee of Gilead Sciences, Inc. L. Ye: Corporate appointments; LY is an employee of Gilead Sciences, Inc. K. Chen: Corporate appointments; KC is an employee of Gilead Sciences, Inc. P.C. Taylor: Consultancies; PCT has served as a consultant to AbbVie, Biogen, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Pfizer, BMS, Roche, Sanofi, Nordic Pharma, Fresenius, and UCB. Grants/research support; PCT reports research grants from Gilead Sciences, Inc.; Galapagos, and Celgene.

scholarly journals FRI0128 FILGOTINIB PROVIDED RAPID AND SUSTAINED IMPROVEMENTS IN FUNCTIONAL STATUS, PAIN, HEALTH-RELATED QUALITY OF LIFE, AND FATIGUE IN PATIENTS WITH RHEUMATOID ARTHRITIS AND INADEQUATE RESPONSE TO METHOTREXATE: RESULTS FROM THE FINCH 1 STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 645.2-646
Author(s):  
A. Kivitz ◽  
Y. Tanaka ◽  
S. Lee ◽  
L. Ye ◽  
H. Hu ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Pain Scale ◽  
Inadequate Response ◽  
Health Related Quality ◽  
Research Support ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
Time Point

Background:In the FINCH 1 study, filgotinib (FIL)—an oral, potent, selective Janus kinase 1 inhibitor—in combination with methotrexate (MTX) provided significant improvements in the signs and symptoms of rheumatoid arthritis (RA) in patients (pts) with inadequate response to MTX.1While EULAR guidelines recommend a treat-to-target approach focusing on reducing inflammation to prevent joint damage, physical disability, and mortality, pts consider control of pain and fatigue, along with maintenance of physical function and health-related quality of life (HRQoL), to be important aspects for their care.2,3Objectives:To evaluate the rate and magnitude of change in patient-reported outcomes (PROs) from FINCH 1.Methods:In the FINCH 1 study (NCT02889796), pts with active RA received oral FIL 200 mg + MTX, FIL 100 mg + MTX, PBO + MTX, or subcutaneous adalimumab (ADA) 40 mg + MTX for up to 52 weeks (W); pts receiving PBO at W24 were rerandomised 1:1 to FIL 100 or 200 mg. PROs included the HAQ-DI and VAS pain scale, SF-36, and FACIT-Fatigue questionnaire. The change from baseline (CFB) at each time point was assessed up to W52 for each treatment group. The mixed-effects model for repeated measures was used to compare each FIL group with PBO for the CFB at each time point through W24. The logistic regression model was used to compare each FIL group with PBO for the proportion of pts achieving the minimum clinically important difference (MCID) of ≥0.22 reduction in CFB in HAQ-DI at each time point through W24.Results:Of 1755 pts randomised and treated (475 FIL 200 mg + MTX; 480 FIL 100 mg + MTX; 325 ADA + MTX; and 475 PBO + MTX), 1417 (80.7%) received study drug through W52. As early as W2 through W24, pts receiving either dose of FIL experienced nominally significantly greater (p <0.001) CFB in HAQ-DI and VAS pain scale than those receiving PBO; CFB improvements were maintained through W52 (Fig 1A, B). At W2, compared with PBO (40.2%), a nominally significantly greater proportion of pts achieved the HAQ-DI MCID in both the FIL 200 (52.5%; p <0.001) and 100 mg (46.7%; p = 0.043) groups. This benefit vs PBO was maintained up to W24 and the proportion of pts who achieved a HAQ-DI reduction of ≥0.22 remained ≥75.8% in the FIL 200 mg group and ≥71.5% in the FIL 100 mg group from W12 through W52. FIL provided nominally significantly greater improvement in HRQoL vs PBO at W4 and W12 for both the CFB of the SF-36 Physical Component Summary (PCS) (p <0.001) and Mental Component Summary (MCS) (p ≤0.006); nominal significance was also seen at W24 for CFB of SF-36 PCS (Fig 2A, B). By W4, pts receiving either dose of FIL reported a nominally significantly greater mean CFB in FACIT-Fatigue scores vs PBO (p <0.001); significance was maintained through W24 and improvement in reported fatigue continued through W52 in the FIL groups (Fig 2C). In general, CFB for HAQ-DI, VAS pain scale, and FACIT-Fatigue observed for the FIL groups was higher or comparable to ADA at various time points (Fig 1, 2).Conclusion:Both doses of FIL provided rapid and sustained improvements in functional status, pain, HRQoL, and fatigue compared with PBO for pts with RA and inadequate response to MTX throughout the 52-week period.References:[1]Combe BG, et al.Ann Rheum Dis.2019;78 (Suppl 2):A77.[2]Fautrel B, et al.Rheumatol Int.2018;38:935–47.[3]Smolen JS, et al.Ann Rheum Dis.2017;76:960–77.Disclosure of Interests: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, Susan Lee Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Lei Ye Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Hao Hu Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Robin Besuyen Shareholder of: Galapagos, Employee of: Galapagos, 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

scholarly journals P216 Effects of filgotinib on anaemia, thrombocytopoenia and leukopoenia: results from a Phase 3 study in patients with active RA and prior inadequate response or intolerance to bDMARDs

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
David Walker ◽  
Mark C Genovese ◽  
Kenneth Kalunian ◽  
Jacques-Eric Gottenberg ◽  
Beatrix Bartok ◽  
...  
Keyword(s):  
Janus Kinase ◽  
Stock Ownership ◽  
Inadequate Response ◽  
Phase 3 ◽  
Double Blind ◽  
Treatment Groups ◽  
Normal Platelet ◽  
Haematopoietic Growth Factor ◽  
Baseline Haemoglobin ◽  
Low Levels

Abstract Background Cytopoenias are common in patients treated for rheumatoid arthritis (RA) with non-janus kinase 1 (JAK1)-selective inhibitors, possibly due to JAK2-mediated haematopoietic growth factor inhibition. We investigated the extent of cytopoenia in patients with active RA, despite prior treatment with biological disease-modifying antirheumatic drugs (bDMARDs), treated with the JAK1-selective inhibitor filgotinib (FIL), in a Phase 3 trial (FINCH2; NCT02873936). Methods In the double-blind, Phase 3 FINCH2 trial, patients were randomised 1:1:1 to receive oral FIL 200mg, 100mg, or placebo (PBO) once daily for 24 weeks (W) + conventional synthetic DMARDs. We assessed shifts from baseline at 12 and 24 weeks in haemoglobin, platelets, neutrophils and lymphocytes. Results 448 patients were treated: FIL 200mg, n = 147; FIL 100mg, n = 153; PBO, n = 148. Overall, haemoglobin, platelet, lymphocyte and neutrophil levels remained consistent throughout the study. At baseline, 129 (28.8%), 4 (0.9%), 10 (2.2%) and 26 (5.8%) patients had mild-moderate low levels of haemoglobin, platelets, neutrophils and lymphocytes, respectively, and 5 (1.1%) had severely low levels of lymphocytes. Of the patients with mild-moderate low haemoglobin levels at baseline, 10-13% achieved normal levels by W24 vs 8% receiving PBO (Table). Of those with normal baseline haemoglobin levels, 6-10% had mild low levels at W24. All patients with baseline mild-moderate low platelets and neutrophils had normal levels at W24, except one patient with mild neutropoenia receiving FIL 100mg. Of the patients with normal platelet and neutrophil levels at baseline, &gt;94% maintained these at W24 in all treatment groups. By W24, 3.2%, 5.2% and 2.2% of patients treated with FIL 200mg, FIL 100mg and PBO, respectively in the baseline mild-moderate subgroup and 1.7% in the severe subgroup treated with FIL 100mg had normal lymphocyte counts. Conclusion In this study, most patients in the baseline normal cell count subgroups maintained this status over 24 weeks of FIL treatment. Of the patients with mild-to-moderately low haemoglobin at baseline, &gt;9% shifted towards haemoglobin normalisation. Similar patterns of improvement from baseline were observed for platelet, lymphocyte and neutrophil counts. FIL appears not to increase the incidence of cytopenias in patients with active RA despite prior biologic therapies. Disclosures D. Walker: Other; Received support from Lilly, Pfizer, Novartis, Roche. M.C. Genovese: Other; Received support from Gilead Sciences Inc., Galapagos NV, AbbVie Inc. Eli Lilly and Company, Pfizer. K. Kalunian: Grants/research support; Grand support from Gilead. J. Gottenberg: None. B. Bartok: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Y. Tan: Corporate appointments; Employee of Gilead Sciences, Inc... Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. Y. Guo: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. C. Tasset: Other; Employee of Galapagos. J.S. Sundy: Corporate appointments; Employee of Gilead Sciences, Inc. Shareholder/stock ownership; Shareholder of Gilead Sciences, Inc. K. de Vlam: None. T. Takeuchi: None.

scholarly journals Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial

RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e001040 ◽  
Author(s):  
Vibeke Strand ◽  
Eduardo Mysler ◽  
Robert J Moots ◽  
Gene V Wallenstein ◽  
Ryan DeMasi ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Controlled Trial ◽  
Inadequate Response ◽  
Link Type ◽  
Combination Treatments ◽  
Sf 36 ◽  
Patient Reported ◽  
Phase Iiib

ObjectiveTo provide the first direct comparison of patient-reported outcomes (PROs) following treatment with tofacitinib monotherapy versus tofacitinib or adalimumab (ADA) in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA) with inadequate response to MTX (MTX-IR).MethodsORAL Strategy (NCT02187055), a phase IIIB/IV, head-to-head, randomised controlled trial, assessed non-inferiority between tofacitinib 5 mg two times per day monotherapy, tofacitinib 5 mg two times per day+MTX and ADA 40 mg every other week+MTX. PROs assessed included the following: Patient Global Assessment of disease activity (PtGA), Pain, Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue and 36-Item Short-Form Health Survey (SF-36) summary and domain scores.ResultsSubstantial improvements from baseline were reported across all PROs in all treatment arms, which, in the majority, met or exceeded minimum clinically important differences. Compared with tofacitinib monotherapy, tofacitinib+MTX combination treatment conferred significantly greater improvements in PtGA, Pain and SF-36 physical component summary scores at month 6. Statistically or numerically greater improvements were often, but not uniformly, reported for combination treatments compared with tofacitinib monotherapy at other time points.ConclusionTreatment with tofacitinib+MTX, ADA+MTX and tofacitinib monotherapy resulted in clinically meaningful improvements in PROs in MTX-IR patients with RA. These were comparatively greater with combination treatments versus tofacitinib monotherapy, although differences between treatment arms were small, limiting our ability to confer clinical meaning.Trial registration numberNCT02187055.

scholarly journals Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden—a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000806 ◽  
Author(s):  
Vibeke Strand ◽  
Kurt de Vlam ◽  
Jose A Covarrubias-Cobos ◽  
Philip J Mease ◽  
Dafna D Gladman ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Janus Kinase ◽  
Phase Iii ◽  
Placebo Patient ◽  
Pain Patient ◽  
Inadequate Response ◽  
Patient Reported ◽  
Disease Modifying

ObjectivesTofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). We evaluated patient-reported outcomes (PROs) in patients with PsA refractory to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR) and tumour necrosis factor inhibitor-naïve in a 12-month, phase III randomised controlled trial (OPAL Broaden [NCT01877668]).MethodsPatients (N=422) received tofacitinib 5 mg or 10 mg twice daily, adalimumab 40 mg subcutaneously every 2 weeks or placebo advancing to tofacitinib 5 mg or 10 mg twice daily at month 3. Least squares mean changes from baseline and percentages of patients reporting improvements ≥minimum clinically important differences (MCID); and scores ≥normative values in: Patient Global Assessment of disease activity (PtGA), Pain, Patient Global Joint and Skin Assessment (PGJS), Short Form-36 Health Survey version 2 (SF-36v2), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), EuroQol 5-Dimensions-3-level questionnaire (EQ-5D-3L) and Ankylosing Spondylitis Quality of Life (ASQoL) were determined. Nominal p values were cited without multiple comparison adjustments.ResultsAt month 3, PtGA, Pain, PGJS, FACIT-Fatigue, EQ-5D-3L, ASQoL and SF-36v2 Physical Component Summary (PCS), physical functioning (PF), bodily pain (BP) and vitality domain scores exceeded placebo with both tofacitinib doses (p≤0.05); SF-36v2 social functioning with 5 mg twice daily (p≤0.05). Percentages reporting improvements ≥MCID in PtGA, Pain, PGJS, FACIT-Fatigue, ASQoL and SF-36v2 PCS, PF, BP and general health scores exceeded placebo with both tofacitinib doses (p≤0.05) and were similar with adalimumab.ConclusioncsDMARD-IR patients with active PsA reported statistically and clinically meaningful improvements in PROs with tofacitinib compared with placebo at Month 3.

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