The rate of infection was 0.91 per patient-year of follow-up in ustekinumab-treated patients, and the rate of serious infections was 0.02 per patient-year of follow-up in ustekinumab-treated patients (199 serious infections in 11,581 patient-years of follow-up) and serious infections reported included pneumonia, anal abscess, cellulitis, diverticulitis, gastroenteritis and viral infections.In clinical studies, patients with latent tuberculosis who were concurrently treated with isoniazid did not develop tuberculosis.In the placebo-controlled period of the psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0.11 per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 929 patient-years of follow-up) compared with 0.23 for placebo-treated patients (1 patient in 434 patient-years of follow-up). Indicated trademarks are registered trademarks of their respective owners.
Stelara Prices, Coupons and Patient Assistance Programs. Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA active tuberculosis; see section 4.4).In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. Patients receiving STELARA should be monitored closely for signs and symptoms of active tuberculosis during and after treatment.Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. In these studies, 2.2% of 785 placebo treated patients and 1.9% of 790 patients treated with the recommended dose of ustekinumab reported adverse events occurring during or within an hour of the infusion.Paediatric patients 6 years and older with plaque psoriasisThe safety of ustekinumab has been studied in two phase 3 studies of paediatric patients with moderate to severe plaque psoriasis. IL-12 and IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages and dendritic cells, and both cytokines participate in immune functions; IL-12 stimulates natural killer (NK) cells and drives the differentiation of CD4+ T cells toward the T helper 1 (Th1) phenotype, IL-23 induces the T helper 17 (Th17) pathway.
‡The recommended dosing for Humira
Patients were randomized to receive a subcutaneous maintenance regimen of either 90 mg ustekinumab every 8 weeks, 90 mg ustekinumab every 12 weeks or placebo for 44 weeks (for recommended maintenance posology, see section 4.2 of the STELARA Solution for injection (vial) and Solution for injection in pre-filled syringe SmPC).Significantly greater proportions of patients were in clinical remission in both ustekinumab treated groups compared to the placebo group at week 44 (see Table 6).In patients who failed conventional therapy, but not a biologicIn patients who failed conventional therapy, but not a biologic** Clinical remission is defined as Mayo score ≤2 points, with no individual subscore > 1.The beneficial effect of ustekinumab on clinical response, mucosal healing and clinical remission was observed in induction and in maintenance both in patients who failed conventional therapy but not a biologic therapy, as well as in those who had failed at least one prior TNFα antagonist therapy including in patients with a primary non-response to TNFα antagonist therapy. Additionally in Crohn's disease, clearance was affected by C-reactive protein, TNF antagonist failure status and race (Asian versus non-Asian). As part of the monitoring of the patient's psoriasis, physicians should be alert for symptoms of erythrodermic psoriasis or exfoliative dermatitis. This presentation is not intended to compare the relative safety or efficacy of these treatments. essentially 'sodium-free'. The infusion solution is to be composed of the number of vials of STELARA 130 mg as specified in Table 1 (see section 6.6 for preparation).The first subcutaneous dose should be given at week 8 following the intravenous dose. No data are available.STELARA 130 mg is for intravenous use only. No cases of RPLS were observed in clinical studies of Crohn’s disease or ulcerative colitis.
CADMUS evaluated 110 patients 12 to 17 years of age with moderate to severe plaque psoriasis.
In Crohn's disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of STELARA. The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.STELARA concentrate for solution for infusion must be diluted and prepared by a healthcare professional using aseptic technique.1.
Before live viral or live bacterial vaccination, treatment with STELARA should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination. CD=Crohn's disease; TNF=tumor necrosis factor; UC=ulcerative colitis.
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