Volume 146, Issue 1, Pages e1 (January 2014)

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Volume 146, Issue 1, Pages 96-109.e1 (January 2014) Subcutaneous Golimumab Maintains Clinical Response in Patients With Moderate-to- Severe Ulcerative Colitis  William J. Sandborn, Brian G. Feagan, Colleen Marano, Hongyan Zhang, Richard Strauss, Jewel Johanns, Omoniyi J. Adedokun, Cynthia Guzzo, Jean–Frederic Colombel, Walter Reinisch, Peter R. Gibson, Judith Collins, Gunnar Järnerot, Paul Rutgeerts  Gastroenterology  Volume 146, Issue 1, Pages 96-109.e1 (January 2014) DOI: 10.1053/j.gastro.2013.06.010 Copyright © 2014 AGA Institute Terms and Conditions

Figure 1 PURSUIT-M study design. Gastroenterology 2014 146, 96-109.e1DOI: (10.1053/j.gastro.2013.06.010) Copyright © 2014 AGA Institute Terms and Conditions

Figure 2 Study participation status through week 54. AE, adverse event; LTF, lost to follow-up evaluation; q4w, every 4 weeks; UTE, unsatisfactory therapeutic effect; W/D, withdrawn. Gastroenterology 2014 146, 96-109.e1DOI: (10.1053/j.gastro.2013.06.010) Copyright © 2014 AGA Institute Terms and Conditions

Figure 3 Proportion of golimumab-induction responders who (A) maintained clinical response through week 54; (B) achieved clinical remission at both weeks 30 and 54; (C) achieved mucosal healing at both weeks 30 and 54; (D) maintained clinical remission among those who were in clinical remission at baseline; and (E) achieved corticosteroid-free clinical remission at week 54 among those who were receiving corticosteroids at baseline. (A–E) Patients who had a prohibited change in UC medication, an ostomy or colectomy, a dose adjustment, or discontinued study agent because of a lack of therapeutic effect before the week 54 visit were considered not to have a clinical response, be in clinical remission, be in corticosteroid-free clinical remission, or have mucosal healing. (A–D) Patients who had all 4 Mayo subscores missing at weeks 30 or 54 were considered not to be in clinical response or clinical remission. Patients who had a missing endoscopy subscore at week 30 or week 54 were considered not to have mucosal healing. (E) Patients who had a missing value in corticosteroid use at a time point had their last available value carried forward to that time point. UC, ulcerative colitis. Gastroenterology 2014 146, 96-109.e1DOI: (10.1053/j.gastro.2013.06.010) Copyright © 2014 AGA Institute Terms and Conditions

Figure 4 (A) Median (interquartile range [IQR]) partial Mayo score through week 54, (B) time to loss of clinical response, (C) time to loss of clinical remission among patients in clinical remission at baseline, (D) clinical response through week 54 or in clinical remission at both weeks 30 and 54 by serum golimumab concentration quartiles at week 54. W0I, week 0 of induction; W0M, week 0 of maintenance. Gastroenterology 2014 146, 96-109.e1DOI: (10.1053/j.gastro.2013.06.010) Copyright © 2014 AGA Institute Terms and Conditions

Supplemental Consort Diagram for Evaluable Patients Gastroenterology 2014 146, 96-109.e1DOI: (10.1053/j.gastro.2013.06.010) Copyright © 2014 AGA Institute Terms and Conditions