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* = Presenting author

P522 A multicentre open-label study assessing pharmacokinetics, efficacy, and safety of subcutaneous golimumab in paediatric patients with moderately to severely active ulcerative colitis

D. Turner*1, G. Veereman2, J. Hyams3, A. Griffiths4, D. Chan5, O. J. Adedokun5, L. Damaraju5, R. Strauss5

1Shaare Zedek Medical Centre, The Hebrew University of Jerusalem, The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Jerusalem, Israel, 2Free University Brussels, Brussels, Belgium, 3Connecticut Children’s Medical Centre, Hartford, Connecticut, United States, 4The Hospital for Sick Children, Toronto, Canada, 5Janssen R & D, LLC, Spring House, Pennsylvania, United States

Background

Paediatric patients with moderate-to-severe ulcerative colitis (UC) who fail 5-ASAs, corticosteroids, and immunomodulators have limited alternative approved treatment options. Golimumab is a subcutaneous (SC) anti-tumour necrosis factor (anti-TNF) agent with potential to offer such patients a safe, effective, and convenient treatment option.

Methods

PURSUIT PEDS PK is a multicentre open-label study with a pharmacokinetic (PK) portion (week 0–14) and a study extension (week 14–126); we report here results through week 14. Patients aged 2–17 years with moderate-to-severe UC (Mayo score 6–12, endoscopy subs-core ≥ 2) who failed previous therapy as noted above and were naïve to anti-TNF treatment were enrolled. Patients received SC golimumab induction at week 0 and 2 by weight (<45 kg [90 → 45 mg/m2]; ≥45 kg [200 → 100mg]). At week 6, Mayo clinical responders continued golimumab maintenance q4w (< 45kg [45 mg/m2]; ≥ 45kg [100 mg]). Key outcome measures (PK, immunogenicity, efficacy, and safety) were evaluated and compared with those observed in the adult UC Phase 3 study.

Results

In total, 35 patients enrolled and received ≥ 1 dose of golimumab. Baseline characteristics are summarised in Table 1; 85.7% received ≥ 1 concomitant UC medications (oral/parenteral corticosteroids [34.3%], immunomodulators [57.1%], and 5-ASAs [65.7%]). Serum golimumab concentrations from baseline through week 6 were similar between the paediatric and adult populations. Clinical response and remission at week 6 by Mayo score were 60% and 43%, respectively; mucosal healing was noted in 54% (Table 2). These results in the paediatric UC population were generally comparable to or numerically greater than in the adult Phase 3 study. Through week 14, 94.3% of patients reported ≥ 1 adverse event (AE); 8.6% had an AE leading to discontinuation; 37.1% reported infections (none serious); 17.1% reported injection site reactions (all mild); 31.4% reported serious AEs (majority were UC flares). Further, 3 patients were positive for antibodies to golimumab at week 14 using a drug tolerant enzyme immunoassay. No opportunistic infections, malignancies, or deaths were reported.

Conclusion

Golimumab was generally well tolerated in this small open-label study of paediatric patients with UC. The PK, efficacy, and safety outcomes observed were comparable with those previously reported in the golimumab adult UC Phase 3 study.

Table 1 Summary of Baseline Characteristics*

Table 2 Summary of Key Clinical Outcomes at Week 6