OP0017 NINTEDANIB REDUCED DECLINE IN FORCED VITAL CAPACITY ACROSS SUBGROUPS OF PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE: DATA FROM THE SENSCIS TRIAL

Abstract

Background In the SENSCIS trial, nintedanib reduced the progression of interstitial lung disease associated with systemic sclerosis (SSc-ILD) compared with placebo, as demonstrated by a significantly lower rate of decline in forced vital capacity (FVC) over 52 weeks (primary endpoint). Objectives To assess the effect of nintedanib on the rate of decline in FVC in the SENSCIS trial across pre-specified subgroups defined by baseline characteristics. Methods Patients with SSc-ILD with onset of first non-Raynaud symptom Results A total of 576 patients were treated (288 in each group). Most (75.2%) of patients were female, 51.9% had diffuse cutaneous SSc, and 48.4% were taking mycophenolate at baseline. Mean ± SD age was 54.0 ± 12.2 years and 21.4% of patients were aged ≥65 years. Nintedanib had a consistent effect on reducing the rate of FVC decline across pre-specified subgroups defined by baseline characteristics (p>0.05 for all treatment-by-time-by-subgroup interactions) (figure). Conclusion Nintedanib is effective at reducing ILD progression in a broad range of patients with SSc-ILD. Disclosure of Interests Oliver Distler Grant/research support from: Prof. Distler received research funding from Actelion, Bayer, Boehringer Ingelheim and Mitsubishi Tanabe to investigate potential treatments of scleroderma and its complications, Consultant for: Prof. Distler has/had consultancy relationship within the last 3 years with Actelion, AnaMar, Bayer, Boehringer Ingelheim, ChemomAb, espeRare foundation, Genentech/Roche, GSK, Inventiva, Italfarmaco, iQvia, Lilly, medac, MedImmune, Mitsubishi Tanabe Pharma, Pharmacyclics, Novartis, Pfizer, Sanofi, Serodapharm and UCB in the area of potential treatments of scleroderma and its complications. In addition, he had/has consultancy relationship within the last 3 years with A. Menarini, Amgen, Abbvie, GSK, Mepha, MSD, Pfizer and UCB in the field of arthritides and related disorders, Kristin Highland Grant/research support from: Kristin Highland is a site PI for the SENSCIS trial (Dr Highland’s institution has the contract for the study) which is funded by Boehringer Ingelheim., Consultant for: Kristin Highland is a paid consultant for Boehringer Ingelheim through her role sitting on the steering committee., Speakers bureau: Kristin Highland is on the speakers’ bureau for Boehringer Ingelheim., Martina Gahlemann Employee of: Employee of Boehringer Ingelheim , Arata Azuma Consultant for: Arata Azuma has received personal fees from Boehringer Ingelheim, Shionogi & Co., Ltd, Taiho Pharmaceutical Co., Ltd, and Asahikasei Pharma Co., Aryeh Fischer Grant/research support from: Aryeh Fischer has received a grant from Boehringer Ingelheim (Consultant/steering committee member/principal investigator on clinical trials)., Consultant for: Aryeh Fischer has received personal fees from Boehringer Ingelheim (Consultant/steering committee member/principal investigator on clinical trials), Genentech-Roche (Consultant/steering committee member/principal investigator on clinical trials), Pfizer (Consultant) and Genentech (Consultant)., Maureen Mayes Grant/research support from: Maureen Mayes is a clinical trial investigator for Boehringer-Ingelheim; Galapagos, Reata, Sanofi, Merck-Serono, Consultant for: Maureen Mayes is a member of scientific advisory boards for Galapagos NV (Pharma), Boehringer-Ingelheim, Mitsubishi-Tanabe, Astellas: Grant Review Board for Actelion., Speakers bureau: Maureen Mayes received personal fees for being a conference speaker on the use of autoantibodies in connective tissue diseases for Medtelligence, Ganesh Raghu Grant/research support from: Ganesh Raghu is the principal investigator for IPF net studies and is a steering committee member for IPF net studies for the NIH., Consultant for: Ganesh Raghu is a consultant for Boehringer Ingelheim, Bellerophan, Biogen, BMS, Fibrogen, Gilead, Nitto, Revistan, Promedior, Sanofi, Veracyte and Roche-Genentech; and a consultant and chair of the DSMB for Avalyn., Wiebke Sauter Employee of: Wiebke Sauter is an employee of Boehringer Ingelheim, Mannaig Girard Employee of: Mannaig Girard is an employee of Boehringer Ingelheim, Margarida Alves Employee of: Employee of Boehringer Ingelheim, Emmanuelle Clerisme-Beaty Employee of: Emmanuelle Clerisme-Beaty is an employee of Boehringer Ingelheim, Susanne Stowasser Employee of: Susanne Stowasser is an employee of Boehringer Ingelheim, Masataka Kuwana Grant/research support from: Actelion, Consultant for: Chugai, Reata, GlaxoSmithKline, Bayer, Boehringer-Ingelheim, Corpus, CSL-Berling, Mochida, Speakers bureau: Actelion, Pfizer, Bayer, Nippon Shinyaku, Chugai, Toby M Maher Shareholder of: Has stock options or bond holdings in a for-profit corporation in Apellis, Grant/research support from: Received funds from BI advisory board participation and conference travel. Received research funding and/or consulting fees or other remuneration from GSK, UCB, AstraZeneca, Roche, Bayer, Biogen Idec, Cipla, Prometic, and Sanumed, Consultant for: Toby Maher has received consultancy or speakers fees from Apellis, AstraZeneca, Bayer, Biogen Idec, Boehringer Ingelheim, Galapagos, GlaxoSmithKline RD and has received consultancy fees from Galecto