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The objective of this report is to perform a systematic review of the beneficial and harmful effects of ustekinumab 45 mg or 90 mg for the treatment of active psoriatic arthritis in adults, alone or in combination with methotrexate. Ustekinumab is a fully human IgG1 kappa monoclonal antibody that binds to the shared p40 subunit of interleukin (IL)-12 and IL-23 and is administered by subcutaneous injection of 45 mg or 90 mg at weeks 0 and 4 and every 12 weeks thereafter. Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that can be associated with psoriasis, a skin disease. This seronegative form of arthritis can cause inflammation of the peripheral and axial joints, enthesitis, dactylitis, psoriatic skin lesions, and symptoms such as fatigue that are linked to systemic inflammation. Several classes of drugs are employed in the treatment of PsA, including nonsteroidal anti-inflammatory drugs (NSAIDs), disease-modifying antirheumatic drugs (DMARDs; i.e., methotrexate, sulfasalazine, and leflunomide), immunosuppressives (cyclosporine), and tumour necrosis factor (TNF) alpha inhibitors (i.e., etanercept, infliximab, golimumab, adalimumab, and certolizumab). Methotrexate remains the most frequently used DMARD despite limited evidence (two small controlled trials of inadequate power) that evaluated methotrexate for PsA.
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Objective: The aim of this study was to evaluate the efficacy of ustekinumab in the treatment of enteropathic arthritis. Materials & methods: A systematic literature search was performed in the Pubmed database of publications between January 2010 and October 2021. Demographic characteristics, comorbidities, inflammatory bowel disease and enteropathic arthritis symptoms, other extraintestinal findings, medical treatments and clinical and laboratory findings for all cases were recorded. Results: A total of 11 patients were included. While clinical and laboratory remission was achieved in terms of inflammatory bowel disease in all patients and enteropathic arthritis in nine patients after ustekinumab treatment, other extraintestinal findings for all patients completely regressed after treatment. Conclusion: Ustekinumab may be an appropriate treatment option for this patient group, considering both pathogenesis and successful treatment responses.
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Background: Ustekinumab targets interleukin (IL)-12 and IL-23 in the treatment of moderate to severe psoriasis. Objective: We sought to evaluate the impact of ustekinumab on infections and malignancies, both theoretical risks of blocking IL-12 and IL-23, in patients exposed up to 3 years. Methods: Rates of infections and malignancies were evaluated in cumulative safety data from 3117 ustekinumab-treated patients across 4 studies. Results: During the placebo-controlled periods, rates of overall infections per 100 patient-years were similar among placebo (121.0), ustekinumab 45-mg (145.7), and ustekinumab 90-mg (132.2) groups, with overlapping confidence intervals, and remained stable through 3 years in ustekinumab groups. Rates of serious infections during the placebo-controlled periods were similar between placebo (1.70) and 90-mg (1.97) groups, yet lower in the 45-mg group (0.49). Rates remained stable (90 mg) or decreased (45 mg) over time, and were comparable with those for the US psoriasis population based on a managed care database. Rates of malignancies during the placebo-controlled periods were comparable among groups (placebo: 1.70; 45 mg: 0.99; 90 mg: 0.98) and remained stable over time in ustekinumab groups. Rates of malignancies, excluding nonmelanoma skin cancer, were comparable with rates expected in the general US population based on the Surveillance, Epidemiology, and End Results database. Limitations: Controlled periods do not extend beyond 12 to 20 weeks. Only 1247 patients were treated for at least 2 years, to date. Comparator database populations may not fully represent the clinical trial population. Conclusions: The emerging safety profile of ustekinumab remains favorable and does not suggest increased rates of infection or malignancy through 3 years. © 2011 by the American Academy of Dermatology, Inc.
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Ustekinumab is a human monoclonal IgG1 antibody targeting the p40 subunit shared by IL-12 and IL-23. We reviewed the published literature by searching from PubMed, EMBASE, Web of Science and ClinicalTrial.gov to evaluate the efficacy and safety of ustekinumab in the treatment of AD. Ten studies including eight cases and two RCT, comprising 107 patients, were included in the systematic review. Analysis all studies, a total of 58 patients (54.2%) gained an effective treatment with little adverse events. Ustekinumab is a well-tolerated and safe treatment with no significant difference in effect from placebo in patients with AD. Further larger randomized controlled trials need to be conducted to identify a suitable regimen for AD and provide more evidence for clinical application.