FRI0122 EFFICACY AND PATIENT-REPORTED OUTCOME MEASURES FROM A TWO-PART MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED WITHDRAWAL TRIAL OF REPOSITORY CORTICOTROPIN INJECTION FOR PERSISTENTLY ACTIVE RHEUMATOID ARTHRITIS

Background: Repository corticotropin injection (RCI) is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides approved for short-term adjunctive treatment of rheumatoid arthritis (RA). Objectives: This two-part, international, multicenter, placebo (PBO)-controlled study assessed the efficacy of RCI in persistently active RA patients (pts) using clinical and patient-reported outcome measures (PROMs) (ClinicalTrials.gov NCT02919761). Methods: Adults ≥18 years with persistently active RA (DAS28-ESR >3.2) despite disease-modifying anti-rheumatic drug and glucocorticoid use received open-label RCI (80 U) subcutaneously 2x/week (BIW) for 12 weeks (Part 1). Pts with DAS28-ESR Results: In the mITT-P (N=259), 62.9% (p Conclusion: RCI for persistently active RA resulted in clinically significant improvements in efficacy endpoints and PROMs for up to 6 months in pts who continued and discontinued RCI after 3 months of initial therapy. References: Acknowledgments: Editorial support was provided by MedLogix Communications, LLC, Itasca, Illinois, under the direction of authors and funded by Mallinckrodt Pharmaceuticals. Disclosure of Interests: Roy Fleischmann Grant/research support from: AbbVie, Akros, Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer, IngelhCentrexion, Eli Lilly, EMD Serono, Genentech, Gilead, Janssen, Merck, Nektar, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Roche, Samsung, Sandoz, Sanofi Genzyme, Selecta, Taiho, UCB, Consultant of: AbbVie, ACEA, Amgen, Bristol-Myers Squibb, Eli Lilly, Gilead, GlaxoSmithKline, Novartis, Pfizer, Sanofi Genzyme, UCB, Daniel Furst Grant/research support from: AbbVie, Actelion, Amgen, BMS, Corbus Pharmaceuticals, the National Institutes of Health, Novartis, Pfizer, and Roche/Genentech, Consultant of: AbbVie, Actelion, Amgen, BMS, Cytori Therapeutics, Corbus Pharmaceuticals, the National Institutes of Health, Novartis, Pfizer, and Roche/Genentech, Speakers bureau: CMC Connect (McCann Health Company), George Wan Employee of: Mallinckrodt Pharmaceuticals, Mary Panaccio Employee of: Mallinckrodt Pharmaceuticals, Jingyu Liu Employee of: Mallinckrodt Pharmaceuticals, Julie Zhu Employee of: Mallinckrodt Pharmaceuticals, Richard Brasington Speakers bureau: Amgen, Mallinckrodt Pharmaceuticals, Novartis, and Pfizer