P142. Subcutaneously administered golimumab induction therapy improves health states measured by EQ-5D in patients with moderately to severely active ulcerative colitis: results from PURSUIT-SC
P. Gibson1, B. Feagan2, C. Marano3, R. Strauss3, C. Han4, J. Johanns3, H. Zhang3, C. Guzzo3, J.-F. Colombel5, W. Reinisch6, J. Collins7, G. Jarnerot8, P. Rutgeerts9, W. Sandborn10, 1Alfred Hospital, Melbourne, Australia, 2Robarts Research Institute, Canada, 3Janssen Research & Development, LLC, United States, 4Janssen Global Services LLC, United States, 5Hôpital Claude Huriez, France, 6Universitätsklinik für Innere Medizin IV, Austria, 7Oregon Health Sciences University, United States, 8Orebro University Hospital, Sweden, 9University Hospital, Gasthuisberg, Belgium, 10University of California San Diego, United States
To assess the effect of SC golimumab (GLM) induction therapy on health states of ulcerative colitis (UC) pts randomized to the PURSUIT SC study using the EQ VAS and EQ5D index.
Patients with moderately to severely active UC defined by a Mayo score of 6–12 inclusive, including endoscopic subscore of ≥2 with inadequate response or intolerance to conventional UC therapies but naïve to treatment with TNF inhibitors were randomized to receive placebo (PBO); GLM 100 mg/50 mg (before dose selection only); GLM 200 mg/100 mg; GLM 400 mg/200 mg at wks 0 and 2. EQ-5D data were collected at wk 0 and 6. Clinically meaningful change was defined as a change in magnitude of one half of standard deviation from baseline (BL).
At wk 6, significantly greater proportions of pts in the GLM 200 mg/100 mg and 400 mg/ 200 mg grps had improvement in the pain/discomfort dimension of the EQ-5D (30.4% and 28.0%, respectively) vs the PBO grp (14.8%) all p < 0.001). GLM-treated pts had greater improvement in EQ VAS (11.3 vs. 5.1, p < 0.0001) and EQ-5D index (0.059 vs. 0.018, p < 0.001) and greater proportions of pts in the GLM-treated grps achieved minimally important change in EQ-5D index (33.9% vs. 20.3%, p < 0.0001) vs PBO, all at wk 6. Change in EQ-5D index was significantly correlated with change in IBDQ scores (r = 0.49, p < 0.001), and pts with remission in IBDQ (>170) had a mean change of 0.09 in EQ-5D index vs a change of 0.01 for those not achieving remission per IBDQ.
|200 mg/100 mg||400 mg/200 mg||Combined|
|Pts randomized in the Phase 3 portion†||255||257||257||514|
|BL EQ VAS||53.7±19.43||52.6±21.24||53.8±20.17||53.2±20.70|
|EQ VAS change at Wk 6||5.1±18.61||11.7±22.13**||10.9±20.97*||11.3±21.54***|
|BL ED-5D index||0.75±0.165||0.77±0.151||0.76±0.160||0.77±0.155|
|ED-5D index change at Wk 6||0.018±0.152||0.062±0.136|
P = 0.0001
|†Patients from site 7257 were excluded. P-value vs. placebo: *<0.01; **<0.001; *<0.0001.|
SC GLM induction treatment significantly improved general health state measured by EQ VAS and EQ-5D index in pts with moderately to severely active UC.