Search in the Abstract Database

Search Abstracts 2013

* = Presenting author

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

Background

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.

Methods

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).

Results

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.

Table: Baseline (BL) and change from BL at week 6 in EQ-5D VAS and EQ-5D index
 PBOGLM
  200 mg/100 mg400 mg/200 mgCombined
Pts randomized in the Phase 3 portion255257257514
BL EQ VAS53.7±19.4352.6±21.2453.8±20.1753.2±20.70
 EQ VAS change at Wk 65.1±18.6111.7±22.13**10.9±20.97*11.3±21.54***
Ns256257257514
BL ED-5D index0.75±0.1650.77±0.1510.76±0.1600.77±0.155
 ED-5D index change at Wk 60.018±0.1520.062±0.136
P = 0.0001
0.057±0.155*0.059±0.146**
Patients from site 7257 were excluded. P-value vs. placebo: *<0.01; **<0.001; *<0.0001.

Conclusion

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.