Ustekinumab (Stelara)
who have had an inadequate response with, loss of response to, or intolerance to either immunomodulators or one or more tumour necrosis factor (TNF) alpha antagonists, or have had an inadequate response with, intolerance to, or demonstrated dependence on corticosteroids. The recommended dosage for u...
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| Format: | eBook |
| Language: | English |
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Ottawa (ON)
Canadian Agency for Drugs and Technologies in Health
2017, April 2017
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| Series: | Common drug review
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| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | who have had an inadequate response with, loss of response to, or intolerance to either immunomodulators or one or more tumour necrosis factor (TNF) alpha antagonists, or have had an inadequate response with, intolerance to, or demonstrated dependence on corticosteroids. The recommended dosage for ustekinumab in the treatment of Crohn's disease is an initial single intravenous (IV) induction dose based on body weight (approximating 6 mg/kg), followed by a 90 mg subcutaneous (SC) maintenance dose eight weeks later, then one dose every eight weeks thereafter as maintenance treatment. For some patients (e.g., "those with low inflammatory burden," per the product monograph), an alternative maintenance regimen of ustekinumab 90 mg SC every 12 weeks may be administered at the discretion of the treating physician. Patients who inadequately respond to the 90 mg SC every 12 weeks regimen may be switched to the every eight weeks regimen. Crohn's disease is a chronic form of inflammatory bowel disease that can affect any part of the gastrointestinal tract but most commonly affects the ileum, colon, and rectum. Immunomodulators and/or corticosteroids may be continued during treatment with ustekinumab. The product monograph recommends that, in patients who have responded to treatment with ustekinumab, corticosteroids may be reduced or discontinued in accordance with standard of care.4 The objective of this report is to perform a systematic review of the beneficial and harmful effects of ustekinumab in accordance with the Health Canada-approved indication for the treatment of Crohn's disease. Only Health Canada-approved dosage regimens for ustekinumab for Crohn's disease were included in this review. Ustekinumab has been previously reviewed through the CADTH Common Drug Review (CDR) for the treatment of plaque psoriasis and psoriatic arthritis.5,6 Common gastrointestinal symptoms experienced by patients with Crohn's disease include abdominal pain, rectal bleeding, fatigue, vomiting, diarrhea, perianal disease, weight loss, and bloating.1-3 According to Crohn's and Colitis Canada, there are approximately 129,000 Canadians living with Crohn's disease (one in 150 people), and it is estimated that 5,700 new cases of Crohn's disease are diagnosed each year.1 Ustekinumab (Stelara) is a fully human immunoglobulin G1 kappa monoclonal antibody that binds to the shared p40 subunit of interleukin (IL)-12 and IL-23.4 Ustekinumab is already approved by Health Canada for the treatment of adults with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and for the treatment of adult patients with active psoriatic arthritis, alone or in combination with methotrexate.4 The current indication under review is for the treatment of adult patients with moderately to severely active Crohn's disease, |
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| Physical Description: | 1 PDF file (xi, 128 pages) illustrations |