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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

Sandborn W.J.1, Rutgeerts P.2, Zhang H.3, Adedokun O.J.3, Xu S.3, Shraim R.3, Marano C.*3

1University of California, San Diego, United States 2University Hospital, Gasthuisberg, Leuven, Belgium 3Janssen Research & Development, LLC, Spring House, United States

Background

Assess clinical characteristics, serum GLM concentrations (conc), & 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.

Methods

In the PURSUIT program, 456 GLM induction responders were randomized at wk0 of maintenance (maint) to PBO (n=154), GLM 50mg (n=151), & GLM 100mg (n=151) q4wks maint treatment through wk52. Partial Mayo scores (pMS) were assessed q4wks; pts with an increase from baseline (BL) (Wk0 of maint) in pMS ≥2 with an absolute pMS ≥4 or an absolute pMS ≥7 were considered in clinical flare & required to undergo 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 BL & wk6 of induction), serum GLM conc, & anti-GLM antibody status (during maint) of nMCR & MCR pts were compared.

Results

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 conc of fecal inflammatory markers fCal & fLac were significantly higher at induction BL & wk6 following induction GLM therapy (Table 1). No significant difference was seen for median conc of CRP. At induction BL, 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 BL, the proportion of pts who normalized at wk6 of induction was not significantly different between nMCR & MCR pts. Median serum GLM levels during maint were significantly lower for nMCR pts vs 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.

Table 1

Conclusion

Pts who did not maintain clinical response to GLM therapy had higher median fCal & fLac levels prior to & following GLM induction treatment. Median CRP conc did not distinguish these pts; however, there was a higher proportion of pts with elevated CRP conc at BL. Other UC disease characteristics did not distinguish between nMCR & MCR pts. During maint treatment, serum GLM conc were lower among pts who did not maintain clinical response compared to those who did.