P446 Characterization of ulcerative colitis patients in the Golimumab PURSUIT-Maintenance study: post-hoc analyses of patients who maintained and did not maintain clinical response through week 54

Abstract

Objective: Assess clinical characteristics, serum golimumab (GLM) concentrations, & immunogenicity to GLM of moderate-severe UC pts who maintained clinical response (MCR) & did not maintain clinical response (nMCR) to GLM through Wk54 of PURSUIT. Method(s): In PURSUIT program1, 2, 3, 456 GLM induction responders were randomized at Wk0 of maintenance to receive PBO(n=154), GLM 50mg(n=151), and GLM 100mg(n=151) q4 wks maintenance treatment through Wk52. Partial Mayo scores (pMS) were assessed q4 wks; pts with an increase from baseline (Wk0 of maintenance) in the pMS >=2 with an absolute pMS >=4 or an absolute pMS >=7 were considered to be in clinical flare & required to undergo an endoscopy to confirm if pt lost response(i.e. no longer demonstrated a decrease from Wk0 of induction of >=30% & >=3 points in the Mayo score with a decrease in the rectal bleeding score >=1 or a rectal bleeding score of 0 or 1). In this post-hoc analysis, the clinical characteristics (at baseline & Wk6 of induction), serum GLM concentrations, & anti-GLM antibody status (during maintenance) of nMCR & MCR pts were compared. Result(s): There were no significant differences in pt demographics or the majority of UC disease characteristics (e.g. Mayo score or extent of disease) between nMCR & MCR pts. However, among nMCR pts, median concentrations of fecal inflammatory markers fCal & fLac were significantly higher at induction baseline & Wk6 following induction GLM therapy (Table). No significant difference was seen for median concentrations of CRP. At induction baseline, the proportion of pts with elevated fCal >= 250 mg/kg & CRP >= 8 mg/L was significantly higher for nMCR pts vs MCR pts, 82.4 % vs 71.4% (P=0.03) & 36.7% vs 24.8% (P=0.029) respectively. Among pts with elevated fCal & CRP at baseline, the proportion of pts who normalized at Wk6 of induction was not significantly different between nMCR & MCR pts.Median serum GLM levels during maintenance were significantly lower for nMCR pts compared to MCR pts(p <0.05); no significant differences were observed during induction. The incidence of pts positive for anti-GLM antibodies was low overall; among nMCR pts, 7(4.7%) were positive for anti-GLM antibodies vs 2(1.4%) of MCR pts. Conclusion(s): Pts who did not maintain clinical response to GLM therapy had higher median fCal & fLac levels prior to & following GLM induction treatment. Median CRP concentrations did not distinguish these pts; however, there was a higher proportion of pts with elevated CRP concentrations at baseline. Other UC disease characteristics did not distinguish between nMCR & MCR pts. During maintenance treatment, serum GLM concentrations were lower among pts who did not maintain clinical response vs those who did. (Table Presented).