Subcutaneous golimumab induced and maintained clinical response in a child with a biological-experienced steroid-refractory flare of ulcerative colitis

Abstract

Introduction: Golimumab is a fully human antitumor necrosis monoclonal antibody that can be administered by either subcutaneous injection or intravenous infusion. Golimumab is approved for the treatment of the adults with rheumatic diseases, and ulcerative colitis, Whereas in children, golimumab is indicated only for the treatment of active polyarticular juvenile idiopathic arthritis. We have written on the off-label use of subcutaneous golimumab, which helped to induce and maintain remission on a low-weight biologically experienced child with steroid-refractory ulcerative colitis flare. Patient concerns: A 13-year-old pancolitis Syrian boy presented with abdominal pain and six to seven times bloody diarrhea. The child had treated with mesalamine 80 mg/kg/day, azathioprine 2.5 mg/kg/day, infliximab with an induction dose of 5 mg/kg at weeks 0, 2, and 6 followed by 5 mg/kg every 8 weeks. Infliximab did not maintain remission as the patient suffered from two flares that required hospital admission, intravenous corticosteroids, and infliximab escalation. Initial tests disclosed leukocytosis, anemia, hypoalbuminemia, an elevation in C-reactive protein and fecal calprotectin. All Stool studies were negative including routine stool cultures, Clostridium difficile toxin, Escherichia coli O157:H7, Cryptosporidium, and microscopy for ova and parasites. A sigmoidoscopy revealed multiple large ulcerations and spontaneous bleeding, colon biopsies were negative for Clostridium difficile and Cytomegalovirus. Cyclosporine, tacrolimus, and adalimumab were unavailable in Syria. Child's parents opposed colectomy as a treatment option. Diagnosis: Ulcerative colitis flare. Interventions: A subcutaneous golimumab with a loading dose of 200 mg at week 0, followed by 100 mg at week 2, then 50 mg every 4 weeks. Outcomes: The patient achieved clinical remission by week sixth and maintained the remission for the next 90 weeks. At the time of last evaluation, tests, including C-reactive protein and fecal calprotectin, were within normal limits, complete colonoscopy revealed erythema, edema, mucosal friability, loss of vascular patterns, and pseudo-polyps. The Pediatric Ulcerative Colitis Activity Index and Mayo scores were 5 and 2 points, respectively. No adverse events were documented. Conclusion: Golimumab has shown potential efficacy and safety in the treatment of ulcerative colitis in children which may indicate a significant future role for subcutaneous golimumab in pediatrics ulcerative colitis.

Ustekinumab for steroid-refractory pancolitis in a biologically naive child: A case report and literature review

“…[6] The only evidence for golimumab in pediatric UC was an open-label pharmacokinetic study and 2 case reports, resulting in a weak recommendation. [19][20][21][22] Except in a few instances, Ustekinumab was administered after other biologics had failed. [23][24][25] Infliximab was the most commonly reported failed biologic, as expected, and Table 2 summarizes reports on Ustekinumab in pediatric IBD patients.…”

Subcutaneous golimumab to treat a biological naïve chronically active ulcerative colitis child. A case report

“…The immunoassays for measuring serum levels of golimumab and golimumab antibodies were comparable in quality, but the quantitative results were not, emphasizing the importance of using the same assay to consistently monitor a patient's treatment [ 16 ]. We previously used golimumab with 200/100 then 50 mg every four weeks to treat acute severe ulcerative colitis low-weight child, which helped him to achieve clinical and endoscopic remission [ 17 ]. This case demonstrated that golimumab with 200 mg, 100 mg at week 0, 2 then 50 mg every four weeks may be safe and effective in the treatment of pediatric chronic active ulcerative colitis in low weight children.…”