IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES FOLLOWING 52 WEEKS OF TREATMENT WITH CERTOLIZUMAB PEGOL IN COMBINATION WITH METHOTREXATE IN DMARD-NAIVE PATIENTS WITH SEVERE, ACTIVE AND PROGRESSIVE RHEUMATOID ARTHRITIS- RESULTS FROM THE C-EARLY RA ...
Author(s)
Emery P1, Bingham C2, Burmester G3, Bykerk V4, Furst D5, Mariette X6, Purcaru O7, Coteur G7, VanLunen B8, Weinblatt M9
1Leeds University, Leeds, UK, 2Johns Hopkins University, Baltimore, MD, USA, 3Universitätsmedizin Berlin, Berlin, Germany, 4Hospital for Special Surgery, New York, NY, USA, 5UCLA, Los Angeles, CA, USA, 6Paris-Sud University, Paris, France, 7UCB Pharma, Brussels, Belgium, 8UCB Pharma, Durham, NC, USA, 9Brigham and Women's Hospital, Boston, MA, USA
OBJECTIVES: To assess effects of CZP+MTX vs placebo (PBO)+MTX on patient reported outcomes in DMARD-naïve patients with severe, active and progressive RA. METHODS: Patients in this double-blind randomized study (NCT01519791) were DMARD-naïve with active RA<1yr diagnosis at baseline (BL), fulfilling 2010 ACR/EULAR criteria; ≥4 swollen and ≥4 tender joints; DAS28[ESR]≥3.2; CRP≥10mg/L and/or ESR≥28mm/hr, rheumatoid factor/ACPA positive. Patients were randomized 3:1 to CZP (400mg Wks 0,2,4 then 200mg Q2W to Wk52)+MTX or PBO+MTX. MTX was initiated at 10mg/wk, increased up to 25mg/wk by Wk8, maximum tolerated dose maintained to Wk52. HAQ-DI, PtGADA, Pain VAS, %pts achieving normative physical function (HAQ-DI≤0.5), health-related QoL (SF-36, EQ-5D-3L) were assessed. At Wk52 changes from baseline (CFB) were analyzed using ANCOVA (LOCF imputation); categorical variables were analyzed using logistic regression (non-responder imputation). Data are LS mean CFB (SE) unless otherwise specified. RESULTS: CONCLUSIONS: In DMARD-naïve patients with severe, active and progressive RA, CZP+MTX showed greater improvements at 1-year in physical function, pain, disease activity and health-related QoL compared to PBO+MTX.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PRM143
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
Musculoskeletal Disorders