Stelara

Stelara Adverse Reactions

ustekinumab

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: The most common adverse reactions (>5%) in controlled periods of the adult psoriasis, psoriatic arthritis and Crohn's disease clinical studies with ustekinumab were nasopharyngitis and headache. Most were considered to be mild and did not necessitate discontinuation of study treatment. The most serious adverse reaction that has been reported for STELARA is serious hypersensitivity reactions including anaphylaxis (see Precautions). The overall safety profile was similar for patients with psoriasis, psoriatic arthritis and Crohn's disease.
Tabulated list of adverse reactions: The safety data described as follows reflect exposure in adults to ustekinumab in 12 phase 2 and phase 3 studies in 5,884 patients (4,135 with psoriasis and/or psoriatic arthritis and 1,749 with Crohn's disease). This includes exposure to STELARA in the controlled and non-controlled periods of the clinical studies for at least 6 months or 1 year (4,105 and 2,846 patients respectively with psoriasis, psoriatic arthritis or Crohn's disease) and exposure for at least 4 or 5 years (1,482 and 838 patients with psoriasis respectively).
Table 7 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis and Crohn's disease clinical studies as well as adverse reactions reported from post-marketing experience. The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 7.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Infections: In the placebo-controlled studies of patients with psoriasis, psoriatic arthritis and Crohn's disease, the rates of infection or serious infection were similar between ustekinumab-treated patients and those treated with placebo. In the placebo-controlled period of clinical studies of patients with psoriasis, patients with psoriatic arthritis and patients with Crohn's disease, the rate of infection was 1.38 per patient-year of follow-up in ustekinumab-treated patients, and 1.35 in placebo-treated patients. Serious infections occurred at the rate of 0.03 per patient-year of follow-up in ustekinumab-treated patients (27 serious infections in 829 patient-years of follow-up) and 0.03 in placebo-treated patients (11 serious infections in 385 patient-years of follow-up) (see Precautions).
In the controlled and non-controlled periods of psoriasis, psoriatic arthritis and Crohn's disease clinical studies, representing 10,953 patient-years of exposure in 5,884 patients, the median follow up was 0.99 years; 3.2 years for psoriasis studies, 1.0 year for psoriatic arthritis studies and 0.6 year for Crohn's disease studies. 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 (178 serious infections in 10,953 patient-years of follow-up) and serious infections reported included anal abscess, cellulitis, pneumonia, diverticulitis, gastroenteritis and viral infections.
In clinical studies, patients with latent tuberculosis who were concurrently treated with isoniazid did not develop tuberculosis.
Malignancies: In the placebo-controlled period of the psoriasis, psoriatic arthritis and Crohn's disease clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0.12 per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 829 patient-years of follow-up) compared with 0.26 for placebo-treated patients (1 patient in 385 patient-years of follow-up). The incidence of non-melanoma skin cancer was 0.48 per 100 patient-years of follow-up for ustekinumab-treated patients (4 patients in 829 patient-years of follow-up) compared to 0.52 for placebo-treated patients (2 patients in 385 patient-years of follow-up).
In the controlled and non-controlled periods of psoriasis, psoriatic arthritis and Crohn's disease clinical studies, representing 10,935 patient-years of exposure in 5,884 patients, the median follow-up was 1.0 years; 3.2 years for psoriasis studies, 1.0 year for psoriatic arthritis studies and 0.6 year for Crohn's disease studies. Malignancies excluding non-melanoma skin cancers were reported in 58 patients in 10,935 patient-years of follow-up (incidence of 0.53 per 100 patient-years of follow-up for ustekinumab-treated patients). The incidence of malignancies reported in ustekinumab-treated patients was comparable to the incidence expected in the general population (standardised incidence ratio = 0.87 [95% confidence interval: 0.66, 1.14], adjusted for age, gender and race). The most frequently observed malignancies, other than non-melanoma skin cancer, were prostate, melanoma, colorectal and breast cancers. The incidence of non-melanoma skin cancer was 0.49 per 100 patient-years of follow-up for ustekinumab-treated patients (53 patients in 10,919 patient-years of follow-up). The ratio of patients with basal versus squamous cell skin cancers (4:1) is comparable with the ratio expected in the general population (see Precautions).
Soln for inj in pre-filled syringe: Hypersensitivity reactions: During the controlled periods of the psoriasis and psoriatic arthritis clinical studies of ustekinumab, rash and urticaria have each been observed in <1% of patients (see Precautions).
Conc for soln for infusion: Hypersensitivity and infusion reactions: In Crohn's disease induction studies, no events of anaphylaxis or other serious infusion reactions were reported following the single intravenous dose. In these studies, 2.4% of 466 placebo treated patients and 2.6% of 470 patients treated with the recommended dose of ustekinumab reported adverse events occurring during or within an hour of the infusion.
Immunogenicity: In psoriasis and psoriatic arthritis clinical studies less than 8% of ustekinumab-treated patients developed antibodies to ustekinumab. In Crohn's disease clinical studies, less than 3% of patients treated with ustekinumab developed antibodies to ustekinumab. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was observed. The majority of patients who were positive for antibodies to ustekinumab had neutralizing antibodies. Efficacy tended to be lower in patients positive for antibodies to ustekinumab; however, antibody positivity did not preclude a clinical response.
Paediatric population: Conc for soln for infusion: Undesirable effects in paediatric patients 12 years and older with plaque psoriasis The safety of ustekinumab has been studied in a phase 3 study of 110 patients from 12 to 17 years of age for up to 60 weeks. In this study, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in