SAT0670 REDUCING THE IMPACT OF THE PATIENT GLOBAL ON BOOLEAN REMISSION CRITERIA FOR RHEUMATOID ARTHRITIS
Authors: Paul Studenic, David T. Felson, Maarten de Wit, Tanja Stamm, Josef S. Smolen, Daniel Aletaha
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> 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. <h3>Objectives:</h3> 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. <h3>Methods:</h3> 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. <h3>Results:</h3> 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 (<b>Figure</b>). 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). <h3>Conclusion:</h3> 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. <h3>Disclosure of Interests:</h3> 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