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P384 Golimumab maintenance treatment and fecal calprotectin predict continuous clinical response in ulcerative colitis.

W. Reinisch*1, 2, J.-F. Colombel3, W. Sandborn4, B. Feagan5, C. Marano6, R. Strauss6, S. Huyck7, R. Yao7, P. Rutgeerts8, H. Zhang9, F. Cornillie10

1McMaster University, Department of Internal Medicine, Hamilton, Canada, 2Medical University, Department of Internal Medicine III, Vienna, Austria, 3Icahn School of Medicine at Mount Sinai, Department of Gastroenterology, New York, United States, 4University of California San Diego, Division of Gastroenterology, La Jolla, United States, 5University of Western Ontario, Robarts Research Institute, London, Canada, 6Janssen R&D, LLC, Clinical Development Immunology, Spring House, United States, 7Merck & Co., Inc., Department of Statistics, Merck Research Laboratories, Whitehouse Station, United States, 8University Hospital Gasthuisberg, Division of Gastroenterology, Leuven, Belgium, 9Merck & Co., Inc., Clinical Biostatistics, Biometrics and Reporting, Whitehouse Station, United States, 10MSD International, Immunology Medical Affairs, Luzern, Switzerland

Background

In PURSUIT-Maintenance (M), patients with moderate to severe ulcerative colitis who had clinical response to golimumab induction treatment at week (wk) 6 were more likely to achieve continuous clinical response (CCR) through wk 54 if they received maintenance treatment with golimumab 50 or 100 mg (47.0% and 49.7% of patients, respectively) than if they had withdrawal of golimumab (31.2%). Subjects were assessed for UC disease activity using the Mayo score at wks 30 and 54 and by partial Mayo every 4 wk (loss of response was confirmed by endoscopy); patients who maintained response through wk 54 were considered to be in CCR.[1] Our current analysis sought to identify early predictors of CCR.

Methods

This post hoc analysis included 456 patients from PURSUIT who were responders at wk 6 after golimumab induction and entered maintenance treatment.[2] Potential predictors evaluated were age; gender; disease duration (≤5y vs >5y); disease extent (extensive vs limited); Mayo score at induction wk 0 (<9 vs ≥9); Mayo score at induction wk 6; stool frequency and rectal bleeding (Mayo) at induction wk 6; CRP, calprotectin, and lactoferrin at induction wk 6 and change from induction wk 0-6; Mayo change from induction wk 0-6; CRP normalization at induction wk 6; mucosal healing (Mayo endoscopy score 0 or 1) at induction wk 6; and golimumab maintenance vs withdrawal. Potential interactions between factors were evaluated. Final stepwise selection of terms was used with significance levels for entry and retention of 0.50 and 0.15, respectively.

Table. Multivariable Model Predicting Continuous Clinical Response.

PredictorOdds Ratio95% Confidence IntervalP-value
Calprotectin wk 6 (log)0.550.394–0.775.0006
Calprotectin change from wk 0–6 (log)1.340.989–1.810.0587
Treatment (golimumab maintenance vs withdrawal)1.911.234–2.957.0037

Results

In univariate analysis, factors significantly associated with CCR were treatment group, wk-6 fecal calprotectin, and wk-6 lactoferrin. Wk-6 calprotectin and lactoferrin were correlated (r=0.78; P<.0001). results of the final multivariable model are shown in Table.

Conclusion

In this post hoc analysis of PURSUIT, maintenance treatment with golimumab and wk-6 calprotectin levels were significant predictors of CCR in moderate to severe UC patients who responded to golimumab induction at wk 6.

Sponsorship: Financial support for this study was provided by Janssen Research & Development, LLC., Spring House, PA, USA.

References:

[1] Sandborn WJ et al, (2014), Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis, Gastroenterology, 146(1):96-109.

[2] Sandborn WJ et al, (2014), Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis, Gastroenterology, 146(1):85-95.