Background: To assess the effect of SC administered GLM induction therapy to improve health related quality of life (HRQOL) in patients (pts) with active UC using data from PURUIT-SC study. Methods: In PURSUIT-SC study, pts with moderately to severely active UC defined by a Mayo score of 6 12 including an endoscopy subscore of >2 with inadequate response or intolerance to conventional UC therapies but naive to treatment with TNF inhibitors were randomized in the Phase 3 portion of PURSUIT SC to receive placebo (PBO) or golimumab (GLM) 200 mg, 100 mg or 400 mg, 200 mg at wks 0 and 2. Disease specific HRQOL was measured using the IBDQ and generic HRQOL was measured using the SF-36 health survey at wks 0 and 6. Clinically meaningful improvements were defined as a change of >20 points in IBDQ score and >5 points in SF-36 PCS and MCS. Correlation of IBDQ remission (>170) with clinical remission defined as a Mayo score <2 points, with no individual subscore >1 was analyzed. Results: At baseline, mean SF-36 PCS and MCS scores were approximately 40, significantly below the US norm of 50. Compared to the PBO grp, significantly greater improvement were observed in the combined GLM-treated grp in IBDQ (27.2 vs. 14.6, p < 0.001), SF-36 PCS (4.14 vs. 2.46, p < 0.01) and MCS (4.89 vs. 1.60, p < 0.001) at wk 6. Mean improvements in IBDQ (27.4 and 27.0), PCS (4.51 and 3.78) and MCS score (4.69 and 5.10) were comparable for GLM 200/100 mg and 400/200 mg grps. In cumulative percentage curve, compared to PBO, greater proportions of pts in each GLM grp achieved "any improvement "to "clinically meaningful improvement" in IBDQ (51.1% vs. 35.2%, p < 0.001), PCS (41.0% vs. 31.6%, p = 0.01) and MCS (42.7% vs. 28.5%, p < 0.001) at wk 6. The distributions of IBDQ score shifted from a mean of 129.4+33.9 at baseline to 156.5+39.8 at wk 6 in GLM treated pts with 45.2% of pts achieving IBDQ remission, vs a mean of 144.2+37.1 in PBO grp with 28.1% achieving IBDQ remission (p < 0.001 vs. combined GLM grp). Greater proportions of pts in each GLM grp achieved clinically meaningful improvement in each of IBDQ dimension scores vs PBO. IBDQ remission was significantly associated with clinical remission by Mayo score with an Odds Ratio (95% CI) of 12.5 (7.2 21.8; p < 0.0001) vs. those without remission in IBDQ. Conclusions: SC induction treatment with GLM significantly improved disease-specific and generic HRQOL in pts with moderately to severely active UC.
Feagan, B., Gibson, P., Marano, C., Strauss, R., Han, C., Johanns, J., … Sandborn, W. (2013). P225 Impact of subcutaneously administered golimumab on disease specific and generic health-related quality of life in patients with moderately to severely active ulcerative colitis: Results from PURSUIT-SC induction. Journal of Crohn’s and Colitis, 7, S99–S100. https://doi.org/10.1016/s1873-9946(13)60247-0