Summary Safety Review - STELARA (ustekinumab) - Serious Skin Disorders (Exfoliative Dermatitis and Erythrodermic Psoriasis)
Review decision
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Issued: 2014-11-24
issue
A safety review was initiated to evaluate the possible link between serious skin disorders called exfoliative dermatitis and erythrodermic psoriasis and the drug STELARA. The review concluded that it was necessary to closely monitor this risk. Health Canada subsequently received additional information from the European Medicines Agency which confirmed the possible link between this risk and STELARA use.
Background
Approved use of STELARA in Canada
STELARA, also known as ustekinumab, is a drug used to treat adults with moderate to severe psoriasis (a persistent inflammatory skin condition) and psoriatic arthritis, a variation of psoriasis that is associated with inflammation of the joints. STELARA is given as an injection under the skin.
Serious skin disorders
Exfoliative dermatitis and erythrodermic psoriasis are serious, yet rare skin conditions characterized by extreme reddening and inflammation of the skin resulting in peeling of the skin over large areas of the body.
Objective
To review the available evidence concerning the risk of developing exfoliative dermatitis and erythrodermic psoriasis, while taking STELARA for psoriasis. The evidence considered included safety information prepared by the manufacturer of the product as requested by Health Canada, medical and scientific literature, and what is known about the use of STELARA in Canada and internationally. The current strategies to minimize the risk were also considered, including a review of the product information available to health professionals and to patients.
Key findings
Use of STELARA in Canadaa
The number of STELARA prescriptions in Canada has been increasing on average by 1% annually, since 2010. It is estimated that approximately 15,094 prescriptions in total were dispensed in 2013.
Canadian reports of exfoliative dermatitis-related events with STELARA
By the time of this review, Health Canada had received 5 reports of skin exfoliation (2 serious and 3 non-serious) and 1 non-serious report of exfoliative dermatitis. None of the reports contained enough information to determine whether or not the drug caused the cutaneous skin reaction.
Scientific reports
Very few skin-related side effects have been reported for STELARA and even fewer of these can be categorised as exfoliative dermatitis and erythrodermic psoriasis.
International datab
Internationally, 20 cases of exfoliative dermatitis and erythrodermic psoriasis have been reported in association with the use of STELARA. In 12 of the 20 cases, the reaction occurred shortly after the individual started the medication and in 4 of these, the affected patient had a similar reaction when given the medication again. However, it is difficult to determine to what extent STELARA contributed to the exfoliative dermatitis and erythrodermic psoriasis or if the patient's underlying psoriasis could also have contributed.
Additional information was recently obtained from a larger patient population in the European Union which consisted of 46 additional cases. In 15 of these cases, STELARA was considered to have a role in the development of exfoliative dermatitis and erythrodermic psoriasis.
Conclusions and actions
Health Canada will continue its ongoing monitoring of adverse reaction information involving STELARA, as it does for all health products on the Canadian market, to identify and assess potential harms.
The new data from the larger population in Europe as well as foreign regulatory actions have prompted Health Canada to consider changes to the product information and to inform healthcare professionals and the public about the risk of exfoliative dermatitis and erythrodermic psoriasis with STELARA.
- Health Canada will be working with the manufacturer to update the Canadian prescribing information.
- A risk communication has been issued to inform healthcare professionals and patients about this risk and the changes to the Canadian prescribing information.
Health Canada will keep Canadians informed and take action, as appropriate, if any new information is identified
Footnotes
- IMS utilization data provided by: IMS Health Canada Inc. An external party cannot refer to nor use IMS data, which have been generated by Health Canada, without a Third Party Agreement in place.
- World Health Organization (WHO) adverse reaction information provided by: The WHO Collaborating Centre for International Drug Monitoring. This information is not homogeneous with respect to the sources of the information or the likelihood that the pharmaceutical product caused the suspected adverse reaction. Also, this information does not represent the opinion of the WHO.