PATIENTS REPORTED OUTCOMES IN PATIENTS WITH RHEUMATOID ARTHRITIS AND ANKYLOSING SPONDYLITIS TREATED WITH GOLIMUMAB- SUB-ANALYSIS OF ASIA POPULATION ENROLLED IN MULTICENTRE PHASE III CLINICAL TRIALS
Author(s)
Genovese M1, Deodhar A2, Hsia E3, Hsu B4, Lin YJ5, Han C61Stanford University, Palo Alto, CA, USA, 2Oregon Health and Science University, Portland, OR, USA, 3Janssen R&D, Inc, Spring House, PA, USA, 4Janssen R&D, Inc., Spring House, PA, USA, 5Janssen Taiwan, Johnson & Johnson Taiwan Ltd, Taipei, Taipei, China, 6Janssen Global Services LLC, Malvern, PA, USA
OBJECTIVES: Examine improvement in physical function, HRQOL&work productivity in a subset of Asian patients from the golimumab(GLM) RA&AS trials. METHODS: RA patients with inadequate response to MTX in GO-FORWARD(N=444)&AS patients despite NSAID/DMARDs in GO-RAISE(N=356) were randomized to SC GLM(50or100mg) or placebo q4wks. At wk16, RA patients with <20% improvement in tender&swollen joint count or AS patients with <20% improvement in both total back pain&morning stiffness entered early escape(i.e.,placebo received GLM 50mg&GLM 50 mg received GLM 100mg).Physical function was assessed using HAQ(0-3) in RA&BASFI (0-10) in AS. HRQOL was assessed using SF-36 PCS(0-100)&SF-36 MCS(0-100). Impact of disease on work productivity was assessed using a productivity VAS(0-10). Clinically meaningful improvement was defined as improvement of ≥0.25 point in HAQ, ≥2 points in BASFI or ≥5 points in SF-36 PCS&MCS. RESULTS: At baseline, RA patients(N=48) had a mean HAQ score of 1.35,&AS patients(N=83) had a mean BASFI score of 3.25; PCS&MCS were 31.5& 42.5, respectively, in RA, &33.2&41.3 in AS; productivity VAS was 5.6 in RA&AS. Compared to placebo+MTX-treated RA patients(N=22), GLM+MTX-treated patients (N=26) had greater mean improvement in HAQ(0.54vs-0.01, p<0.01), PCS(7.9 vs -0.40, p<0.01)&work productivity(-2.4 vs-0.4, p<0.05), the change in MCS was not statistically significant(3.0vs2.1, p>0.05). Compared to placebo-treated AS patients(N=17), GLM-treated patients(N=66) had greater mean improvements in BASFI(1.51vs0.28, p=0.05), MCS(5.3vs-1.1, p<0.05)&work productivity(-2.9vs-0.9, p<0.05); change in PCS was not statistically significant(9.0vs5.7,p>0.05). Greater proportions of RA patients in GLM group than placebo achieved clinically meaningful improvement in HAQ(73.1%vs30%, p<0.01), PCS(61.5%vs25%, p=0.01)&MCS(50%vs35%,p=0.31); in AS, similar trends in clinically meaningful improvement in BASFI, PCS&MCS observed between groups. Improvements in HAQ, BASFI, SF-36&work productivity in GLM-treated patients were sustained over wk52 and 104, &were consistent across populations (Asia vs non-Asia). CONCLUSIONS: Patients from Asia with RA or AS treated with GLM demonstrated improved physical function&HRQOL.
Conference/Value in Health Info
2012-09, ISPOR Asia Pacific 2012, Taipei, Taiwan
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PMS20
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Musculoskeletal Disorders