A recent analysis of adverse event reports submitted to the FDA suggests that the potential risk of cancer associated with Stelara side effects may be significantly higher than similar psoriasis drugs.
In the latest issue of the Institute for Safe Medication Practices (ISMP) QuarterWatch report (PDF), instances of Stelara cancer problems submitted to the FDA during the third quarter of 2015 were examined in comparison to report involving other psoriasis drugs.
Researchers indicate that the data suggests that side effects of Stelara may increase the risk of cancer by a factor of 15 compared to certain other treatments.
Stelara (ustekinumab) is an injectable drug distributed by Janssen, a subsidiary of Johnson & Johnson, for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis. It was first approved by the FDA in 2009. It already carries a warning that indicates it may increase the risk of malignancies, since it is an immunosuppressant.
The ISMP compared a number different psoriasis treatments and the rates of reported cancer associated with each. They included Stelara, the only interleukin 12/23 inhibitor on the market, the anti-tumor necrosis factor (anti-TNF) drugs Enbrel, Remicade, Humira, Cimzia and Simponi, the interleuken 17a inhibitor Consentyx. All of the drugs were compared to Otezla, a phosphodiesterase inhibitor 4 (PDE4) that is known not to have no autoimmune suppressing effects, so was used as a baseline.
Researchers found that the rate of cancer among patients using Stelara was 15 times higher than those taking Otezla. While patients taking anti-TNF drugs like Enbrel, Remicade and Humira were five times more likely to develop cancer than Otezla users, Stelara risks were triple that.
“The cancer signal for ustekinumab was stronger when the psoriasis cases were adjusted for differences in age and gender with an odds ratio of 18.2,” the ISMP report notes. “However, the adjusted estimate excluded numerous cases where age or gender was not reported and therefore assesses smaller amounts of data.”
The ISMP notes that there were signals of potential cancer risks during the Stelara clinical trials on mice and humans.
“The largest, longest clinical trial of ustekinumab excluded patients with any history of most cancers, and those with a history of non-melanoma skin cancer within the last 5 years,” the report notes. “Nevertheless, at 100 weeks of followup 30 malignancies had been reported in 26 patients among approximately 1,230 patients originally enrolled. These included three cases of prostate cancer, two melanomas, and single cases of breast, colon, endometrial, and pancreatic cancer.”
The ISMP reached out to Janssen as part of the report, and the drug maker indicates that it disagrees with the findings and said that the malignancy warning was theoretical, and that it does not believe there is a link between Stelara and cancer..
Psoriasis is a chronic skin disorder affecting about 7.5 million people in the U.S. and about 2% of the world’s population. It often appears as thick red patches of skin topped by white or silvery dead skin cells. It can also appear as lesions, pustules or inflamed skin. About 30% of those with the disorder develop psoriatic arthritis, according to the ISMP.