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Stelara (Ustekinumab) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the label:

  • Infections [see Warnings and Precautions]
  • Malignancies [see Warnings and Precautions]
  • Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions]

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Psoriasis Clinical Studies

The safety data reflect exposure to STELARA® in 3117 psoriasis subjects, including 2414 exposed for at least 6 months, 1855 exposed for at least one year, 1653 exposed for at least two years, 1569 exposed for at least three years, 1482 exposed for at least four years and 838 exposed for at least five years.

Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the STELARA® groups than the placebo group during the placebo-controlled period of Ps STUDY 1 and Ps STUDY 2 [see Clinical Studies].

Table 1. Adverse reactions reported by ≥1% of subjects through Week 12 in Ps STUDY 1 and Ps STUDY 2
STELARA®
Placebo 45 mg 90 mg
Subjects treated 665 664 666
  Nasopharyngitis 51 (8%) 56 (8%) 49 (7%)
  Upper respiratory tract infection 30 (5%) 36 (5%) 28 (4%)
  Headache 23 (3%) 33 (5%) 32 (5%)
  Fatigue 14 (2%) 18 (3%) 17 (3%)
  Diarrhea 12 (2%) 13 (2%) 13 (2%)
  Back pain 8 (1%) 9 (1%) 14 (2%)
  Dizziness 8 (1%) 8 (1%) 14 (2%)
  Pharyngolaryngeal pain 7 (1%) 9 (1%) 12 (2%)
  Pruritus 9 (1%) 10 (2%) 9 (1%)
  Injection site erythema 3 (<1%) 6 (1%) 13 (2%)
  Myalgia 4 (1%) 7 (1%) 8 (1%)
  Depression 3 (<1%) 8 (1%) 4 (1%)

Adverse reactions that occurred at rates less than 1% in the controlled period of Ps STUDIES 1 and 2 through week 12 included: cellulitis, herpes zoster, diverticulitis and certain injection site reactions (pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation).

One case of RPLS occurred during clinical trials [see Warnings and Precautions].

Infections

In the placebo-controlled period of clinical studies of psoriasis subjects (average follow-up of 12.6 weeks for placebo-treated subjects and 13.4 weeks for STELARA®-treated subjects), 27% of STELARA®-treated subjects reported infections (1.39 per subject-year of follow-up) compared with 24% of placebo-treated subjects (1.21 per subject-year of follow-up). Serious infections occurred in 0.3% of STELARA®-treated subjects (0.01 per subject-year of follow-up) and in 0.4% of placebo-treated subjects (0.02 per subject-year of follow-up) [see Warnings and Precautions].

In the controlled and non-controlled portions of psoriasis clinical trials (median follow up of 3.2 years), representing 8998 subject-years of exposure, 72.3% of STELARA®-treated subjects reported infections (0.87 per subject-years of follow-up). Serious infections were reported in 2.8% of subjects (0.01 per subject-years of follow-up).

Malignancies

In the controlled and non-controlled portions of psoriasis clinical trials (median follow up of 3.2 years, representing 8998 subject-years of exposure), 1.7% of STELARA®-treated subjects reported malignancies excluding non-melanoma skin cancers (0.60 per hundred subject-years of follow-up). Non-melanoma skin cancer was reported in 1.5% of STELARA®-treated subjects (0.52 per hundred subject-years of follow-up) [see Warnings and Precautions]. The most frequently observed malignancies other than non-melanoma skin cancer during the clinical trials were: prostate, melanoma, colorectal and breast. Malignancies other than non-melanoma skin cancer in STELARA®-treated patients during the controlled and uncontrolled portions of studies were similar in type and number to what would be expected in the general U.S. population according to the SEER database (adjusted for age, gender and race).1

Psoriatic Arthritis Clinical Studies

The safety of STELARA® was assessed in 927 patients in two randomized, double-blind, placebo-controlled studies in adult patients with active psoriatic arthritis (PsA). The overall safety profile of STELARA® in patients with PsA was consistent with the safety profile seen in psoriasis clinical studies. A higher incidence of arthralgia, nausea, and dental infections was observed in STELARA®-treated patients when compared with placebo-treated patients (3% vs. 1% for arthralgia and 3% vs. 1% for nausea; 1% vs. 0.6% for dental infections) in the placebo-controlled portions of the PsA clinical trials.

Immunogenicity

Approximately 6% of patients treated with STELARA® in psoriasis and psoriatic arthritis clinical studies developed antibodies to ustekinumab, which were generally low-titer. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen. No ustekinumab-related serious hypersensitivity reactions were observed in psoriasis and psoriatic arthritis clinical trials. In psoriasis studies, the majority of patients who were positive for antibodies to ustekinumab had neutralizing antibodies.

The data above reflect the percentage of subjects whose test results were positive for antibodies to ustekinumab and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to ustekinumab with the incidence of antibodies to other products may be misleading.

Post-marketing Experience

Adverse reactions have been reported during post-approval use with STELARA®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to STELARA® exposure.

  •   Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria).
  •   Skin reactions: Pustular psoriasis, erythrodermic psoriasis.


REPORTS OF SUSPECTED STELARA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Stelara. The information is not vetted and should not be considered as verified clinical evidence.

Possible Stelara side effects / adverse reactions in 57 year old male

Reported by a physician from Spain on 2011-10-03

Patient: 57 year old male

Reactions: Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Stelara

Other drugs received by patient: Irbesartan; Metformin HCL; Atorvastatin



Possible Stelara side effects / adverse reactions in 67 year old female

Reported by a physician from United States on 2011-10-06

Patient: 67 year old female

Reactions: Pemphigoid

Suspect drug(s):
Stelara
    Indication: Psoriasis
    Start date: 2011-04-11

Stelara
    Start date: 2009-11-01
    End date: 2011-01-01

Other drugs received by patient: Norvasc; Methotrexate; Fish OIL; Folic Acid; Prednisone; Potassium; Aspirin; Reclast



Possible Stelara side effects / adverse reactions in 87 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-06

Patient: 87 year old female

Reactions: Viral Upper Respiratory Tract Infection, Nasopharyngitis

Suspect drug(s):
Stelara
    Start date: 2011-07-27

Stelara
    Dosage: two induction doses
    Indication: Psoriasis
    Start date: 2011-06-01



See index of all Stelara side effect reports >>

Drug label data at the top of this Page last updated: 2014-03-13

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