AB0720 DEVELOPMENT OF RESPONSE CRITERIA FOR GCA: AN SLR INFORMING AN INTERNATIONAL TASK FORCE

Background Giant cell arteritis (GCA) is the most common form of large vessel vasculitis. While remission and relapse are primary endpoints in randomized clinical trials (RCTs), a definition response missing. We conducted systematic literature review (SLR) to inform an international task force developing new criteria GCA. Objectives To identify descriptors used measure treatment change disease activity GCA RCTs longitudinal observational studies (LOS). Methods An SLR was using Ovid Medline, Embase, Cochrane Central. The research question formulated according PICO framework: population included patients with GCA, any intervention or comparator considered, outcomes addressed were active disease, improvement/response, remission, worsening, relapse, flare, recurrence. LOS > 20 subjects on qualitative included. Titles screening full data extraction performed by 2-3 reviewers. Discordant cases discussed among reviewers until final consensus; if not achieved, methodologist consulted. In case multiple publications from same trial LOS, they only considered separate, pre-specified reported. Results 10,593 retrieved search, which 116 finally for different outcomes’ extracted grouped into categories (Figure 1). Active reported 11/11 (100%) 20/104 (19%) LOS. predominantly defined as combination laboratory components. component described presence symptoms while mainly ESR CRP. Remission 8/11 (73%) 44/104 (42%) resolution signs/symptoms (ESR/CRP) when associated Relapse 90/104 (87%) clinical, recurrence elevation and/or (reinstitution increase glucocorticoids dose) frequently criterion relapse. No standardized found across studies. Most composite (including tapering/discontinuation, maintenance absence over certain time frame) assess endpoint – response. Fourteen imaging analyzed (10 prospective 4 retrospectives). PET-CT studied (n= 10), followed ultrasound (n=3). PET evaluated thorough semiquantitative scores. Ultrasound based intimal wall thickness/halo sign. Conclusion results this showed that internationally accepted elusive so far. extremes spectrum (remission relapse) endpoints. identified will be incorporated future phases development Figure 1. Components assessed definitions improvement, REFERENCES: NIL. Acknowledgements: Disclosure Interests Catalina Sanchez-Alvarez: None declared, Milena Bond: Medha Soowamber: Dario Camellino: Melanie Anderson: Carol Langford Consultant of: Bristol Myers Squibb, Grant/research support from: GlaxoSmithKline, Genentech., Christian Dejaco Speakers bureau: Abbvie, Eli Lilly, Janssen, Novartis, Pfizer, Roche, Galapagos Sanofi, Galapagos, Sparrow AbbVie, Zahi Touma gsk, AstraZeneca, Merck Ucb, Sofia Ramiro LIlly, MSD, UCB.