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OP009. Long-term safety and efficacy of golimumab in patients with moderately to severely active ulcerative colitis: Results from the PURSUIT-SC Maintenance study extension

W. Reinisch1,2, P. Gibson3, W.J. Sandborn4, B.G. Feagan5, C. Marano6, R. Strauss6, J. Johanns6, H. Zhang6, L. Padgett6, J.-F. Colombel7, J. Collins8, P. Rutgeerts9, 1Universitäts-klinik für Innere Medizin III, Vienna, Austria, 2McMaster University, Hamilton, ON, Canada, 3Alfred Hospital, Melbourne, VIC, Australia, 4University of California San Diego, La Jolla, CA, United States, 5Robarts Research Institute, University of Western Ontario, London, ON, Canada, 6Janssen Research & Development, LLC, Spring House, PA, United States, 7Hôpital Claude Huriez, Lille Cedex, France, 8Oregon Health Sciences University, Portland, OR, United States, 9University Hospital, Gasthuisberg, Leuven, Belgium

Background

Objective: To evaluate safety and efficacy through 2 y of SC golimumab (GLM) maintenance in patients with moderately to severely active UC.

Methods

1233 patients were enrolled in the PURSUIT program of GLM induction and maintenance therapy. During PURSUIT-Maintenance, GLM induction responders (464 patients) were randomized to receive PBO, SC GLM 50 mg, or SC GLM 100 mg at baseline (wk0) and q4wks through wk 52. 129 remaining patients who were PBO induction responders were continued on PBO; 635 patients who were non-responders to PBO or GLM induction were treated with GLM 100 mg q4wks. Patients completing treatment through wk 52 and evaluation at wk 54 were eligible to participate in the study extension of approximately 3 y (LTE). Patients entered LTE at the same GLM dose they were receiving at the end of the main study; during LTE, PBO- or GLM 50 mg-treated patients could cross over to GLM 100 mg q4wks upon worsening of UC. Results through wk 104 of LTE are described. All efficacy analyses are based on patients randomized to GLM at wk0 of maintenance who continued receiving GLM during LTE. Safety analyses are based on all patients treated with GLM at any time from wk0 of induction through wk104.

Results

200 patients randomized to GLM in the maintenance study entered LTE and continued receiving GLM. Baseline demographics and disease characteristics of patients entering LTE were similar to those of all patients randomized to GLM at the start of maintenance. The rate of discontinuation prior to wk 104 was 8.5%; reasons included: AEs (3.5%), unsatisfactory therapeutic effect (2.0%), lost to follow-up (0.5%), and “other” (2.5%). Using intention-to-treat analysis (includes treatment failure rules), at wk 104, 80.5% (157/195) of patients had a PGA of 0/1 (range: 84.6–91.8% from wk 56 to wk 92) and 56.4% (110/195) of patients had PGA of 0 (range: 53.8–58.5% from wk 56 to wk 92). 88.5% (154/174) of patients who were not receiving corticosteroids at wk 54 of the maintenance study remained corticosteroid-free through wk 104. At wk 104, 62.2% (120/193) had an IBDQ score ≥170. AEs per 100 patient years of follow-up through wk 104 are presented in the table. Rates of AEs of special interest (e.g. infection, including TB and opportunistic infection) remained low and comparable to wk 54. Malignancy rate through 2 y of GLM treatment was comparable to that observed through wk 54; 3 additional malignancies were observed between wks 54 and 104 - 2 nonmelanoma skin cancers and 1 metastatic colon cancer. There were two additional deaths (biventricular heart dysfunction and sepsis) that occurred between wks 54 and 104.

Table: AE summary per hundred patient years of follow-up through wk 104 of the PURSUIT SC-Maintenance study extension from wk 0 of induction
GLM-treated patients through wk 54 aGLM-treated patients through wk 104 a
Patients treated12331240
Avg duration of follow-up (years)1.01.3
Avg exposure (number of administrations)11.015.5
Total patient years of follow-up1080.11663.6
Patients who died0.40.4
Patients who discontinued study agent due to ≥1 AE16.112.5
Patients with ≥1 of the following events:
 AE406.3349.2
 Serious AE24.319.5
 Infections b95.788.4
 Serious infections b5.24.4
 Infections requiring antimicrobial therapy b47.944.5
 Injection site reaction17.214.6
a Includes data from the time of the first GLM dose onward.
b Infection as assessed by the investigator.

Conclusion

These data continue to support a positive benefit/risk profile for GLM in the treatment of moderate to severe UC; GLM treatment for up to 2 y maintained clinical benefit including a reduction in corticosteroid use. No new safety signals were observed with continued GLM treatment through wk 104; safety profile was similar to wk 54.