FRI0266 Health-Related Quality of Life of Patients with Rheumatoid Arthritis Achieving DAS28 Remission, Improvement in Physical Function and NO Radiographic Progression after Treatment with Intravenous Golimumab
Authors: R. Westhovens, M.E. Weinblatt, C. Han, L. Kim, M. Mack, J. Lu, D. Baker, A. Mendelsohn, C.O. Bingham
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Objectives</h3> To evaluate "comprehensive remission" in patients with rheumatoid arthritis (RA) treated with intravenously administered golimumab (GLM) and the association with normalized health related quality of life (HRQOL). <h3>Methods</h3> GO-FURTHER was a multicenter, randomized, placebo-controlled study. Adult patients with active RA despite MTX therapy (≥6 tender and swollen joints, CRP ≥1.0 mg/dL, and RF and/or anti-CCP positive) were randomized to placebo (PBO) + MTX or GLM (2mg/kg) plus MTX at week 0, 2, and every 8 week thereafter (GLM group). Patients in PBO group with &lt;10% improvement in tender and swollen joint count from baseline at week 16 entered early escape (EE) and received a 2 mg/kg GLM infusion at weeks 16 and 20 and every 8 weeks subsequent. HRQOL was assessed using Short-Form of 36 items questionnaire (SF-36) and FACIT-fatigue. Employability was defined as being employed or to be able to work if job is available. Radiographic progression was measured using Total <i>Sharp score</i> (TSS). "Comprehensive remission" was defined as achieving low disease activity score (DAS28 using CRP &lt;2.6), normalized physical function (HAQ-DI≤0.5) and no radiographic progression (change in TSS ≤ Smallest detectable change). Remission was also assessed using criteria of Simplified Disease Activity Index (SDAI, ≤3.3). <h3>Results</h3> Compared to PBO+MTX group at week 24, greater proportion of patients in GLM IV group achieved DAS28&lt;2.6 (17.7% vs. 5.1%, p&lt;0.001), HAQ-DI score≤0.5 (29.4% vs. 16.2%, p&lt;0.001) or no radiographic progression (91.4% vs. 80.7%, p&lt;0.001). "Comprehensive remission" rate was 10.1% in GLM group vs. 2.5% in PBO+MTX group (p=0.001). Additionally, SDAI remission at week 24 was 7.6% in GLM group vs. 2.0% in PBO+MTX group (P&lt;0.01)."Comprehensive remission" was sustained in the GLM group over time at week 52 (12.4%) or week 100-112 (15.4%). Compared to patients who achieved DAS28 remission or SDAI remission, patients who achieved "comprehensive remission" at week 24 achieved numerically greater improvement in normalized HRQOL in SF-36 PCS and MCS and in FACIT-fatigue, and were more likely regain employability at Week 24, 52 or week 112. <h3>Conclusions</h3> By taking into consideration of outcomes reported by clinician and patient, and radiographic progression, "comprehensive remission" might be a more desirable treatment goal for patients with RA. <h3>Disclosure of Interest</h3> R. Westhovens Grant/research support: Janssen R &amp; D, LLC, M. Weinblatt Grant/research support: Janssen R &amp; D, LLC, C. Han Employee of: Janssen Pharmaceutical Services, LLC, L. Kim Employee of: Janssen R &amp; D, LLC, M. Mack Employee of: Janssen R &amp; D, LLC, J. Lu Employee of: Janssen R &amp; D, LLC, D. Baker Employee of: Janssen R &amp; D, LLC, A. Mendelsohn Employee of: Janssen R &amp; D, LLC, C. Bingham III Grant/research support: Janssen R &amp; D, LLC, Consultant for: Janssen R &amp; D, LLC <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.3819