SAT0670\u2005REDUCING THE IMPACT OF THE PATIENT GLOBAL ON BOOLEAN REMISSION CRITERIA FOR RHEUMATOID ARTHRITIS

Abstract

Background: The patient global assessment (PtGA) is a core set variable to assess disease activity in rheumatoid arthritis (RA). It is strongly linked to patient-reported pain and has shown to be a limiting factor for reaching remission in patients with remittent joint inflammation and normal acute phase response, particularly when the ACR/EULAR Boolean criteria are used. In these, the PtGA may not be greater than 10 on a 0-100 scale to reach remission. Objectives: To analyse the impact of higher cut-offs for or removal of the PtGA applied in the ACR/EULAR Boolean remission on the consistency with the SDAI remission definition, and with respect to long-term structural and functional outcomes. Methods: We retrieved data from six clinical trials testing the efficacy of tumor-necrosis factor inhibitors vs MTX or placebo/MTX. Three trials depicted early RA: ASPIRE (infliximab), Go Before (golimumab), PREMIER (adalimumab); and three late RA: ATTRACT (infliximab), DE019 (adalimumab) and Go Forward (golimumab). We increased the cut-off of the PtGA gradually by 5mm (mBoolean15-REM) up to 30mm, and also omitted the criterion completely (Boolean-NO REM, i.e. requiring only CRP, SJC, TJC≤1). We assessed frequencies of remission by these definitions at 6 and 12 months and evaluated agreement with the Index based (SDAI) definition of remission (which does not include an inherent cut-off for PtGA). Further the impact on functional and structural outcomes after 1 year were explored based on achievement of each of these remission definitions at 6 months. Results: We included 3293 patients in our study, 2121 in early and 1172 in late RA (mean disease duration: 1.5±3.0 and 9.8±8.6 years, respectively). The rates of patients achieving Boolean remission increased with higher allowance for PtGA from 11.9% to 18.8% in early RA, and from 5.9% to 12.4% in late RA at 6 month, and from 19.7% to 29.9% and from 10.7% to 20.9%, respectively, at 1 year. Best agreement with SDAI occurred at a PtGA cut-off of 15mm and 20mm, while with higher allowances for PtGA the disconnect between Boolean and Index based remission increased again (Figure). Radiographic progression was very similar in the different Boolean groups (ranging from a mean of 0.27±4.7 to 0.41±5.1). As expected, removing the PtGA increased functional impairment in remission (% of patients scoring HAQ=0 in Boolean 10, 15, 20, 25, 30, and in the “no PtGA” definition were 68.2%, 63.7%, 60.4%, 56.0%, 54.6% and 47.9%, respectively. Functional scores in late RA were generally worse than in early RA. CRP levels across all definitions, including “no PtGA”, were similar (data not shown). Conclusion: Increasing the PtGA cut-off to 15mm would provide highest consistency between Boolean with the Index based remission, while the integer cut-off of 20mm (or 2/10) would also allow the use on numerical rating scales. This new cut-off would discount the overly stringency of the PtGA in the remission context, while keeping the patient perspective in the core of RA disease activity evaluation. Disclosure of Interests: Paul Studenic: None declared, David T. Felson: None declared, Maarten de Wit: None declared, Tanja Stamm Grant/research support from: TS has received grant support from AbbVie., Paid instructor for: TS has received speaker fees from AbbVie, Janssen, MSD, Novartis, and Roche., Josef S. Smolen Grant/research support from: AbbVie, Eli Lilly, Janssen, MSD, Pfizer Inc, Roche, Consultant for: AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celtrion, Eli Lilly, GlaxoSmithKline, ILTOO, Janssen, Medimmune, MSD, Novartis-Sandoz, Pfizer Inc, Roche, Samsung, Sanofi, UCB, Speakers bureau: AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celtrion, Eli Lilly, GlaxoSmithKline, ILTOO, Janssen, Medimmune, MSD, Novartis-Sandoz, Pfizer Inc, Roche, Samsung, Sanofi, UCB, Daniel Aletaha Grant/research support from: AbbVie, Bristol-Myers Squibb, and MSD, Consultant for: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Medac, Merck, MSD, Pfizer Inc, Roche, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Medac, Merck, MSD, Pfizer Inc, Roche, and UCB