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Risankizumab (Skyrizi) is safe to use over the short and long terms in people with moderate-to-severe psoriasis, according to a recent evaluation of data from more than 20 clinical trials.

Authors of the report, which appeared in the , analyzed short- and long-term safety data from 5 and 17 completed and ongoing phase I-III trials, respectively.

The evaluation was sponsored by AbbVie, which manufactures risankizumab, an IL-23 inhibitor. The FDA approved the drug in 2019 for the treatment of moderate-to-severe plaque psoriasis.

Short-term safety trials included in the analysis covered 1,306 patients receiving 150 mg of risankizumab and 300 patients receiving a placebo, with respective totals of 402.2 and 92.0 patient years (PY). Long-term analyses included 3,072 risankizumab-treated patients, with a total exposure of 7,927 PY.

Exposure-adjusted adverse event rates did not increase with long-term treatment (318 vs. 171 events per 100 PY for short- and long-term analyses). The rate of serious adverse events in long-term risankizumab use was 7.8 per 100 PY. Serious infections occurred in 1.2 per 100 PY, nonmelanoma skin cancer in 0.7 per 100 PY, other malignant tumors excluding nonmelanoma skin cancer in 0.5 per 100 PY, and adjudicated major adverse cardiovascular events in 0.3 per 100 PY.

Kenneth Gordon, MD, is chair of the Department of Dermatology at Medical College of Wisconsin, and served as the study's first author. He recently discussed the findings with the Reading Room. The exchange has been edited for length and clarity.

What was the key knowledge gap this trial was designed to address?

Gordon: With psoriasis being a long-term disease, we need to make certain that exposure to therapeutic agents doesn't have a negative impact over the long term on the overall health of our patients.

This is a follow-up to multiple evaluations on the safety of risankizumab. This evaluation provided more evaluation of the effects of more extended exposure.

How would you summarize your findings?

Gordon: The primary takeaways to me are two things. First, that people with prolonged exposure to risankizumab have no increased risk of significant adverse events. Second is that in comparing the databases of patients who would be candidates for aggressive therapy for both skin and joint disease, the side effect profiles fit in with the expectations we had in these populations.

There is now a strong body of information for not only risankizumab but pretty much any medication within the IL-23 inhibitor class of drugs.

What is your take-home message for clinicians regarding this study specifically or risankizumab in general?

Gordon: These data should be extremely reassuring for both clinicians and patients. Exposure over time is really not a problem.

That said, with risankizumab or any of the other biologics in this class for psoriasis, there's no such thing as a free lunch. We always worry about the side effects of medication and how that applies to the patients in front of us. I always put in the caveat that this is a compilation of clinical trials, and that the patient populations in these trials are oftentimes a little healthier than the general population. Therefore, there is always a risk of underestimating potential adverse impacts.

But longer-term exposure, which I think is what everyone is concerned about, doesn't have an increase in risk that we see.

IMPLICATIONS FOR PRACTICE:

• Risankizumab (Skyrizi) has been shown to be safe and effective over the long term.
• Findings suggest a favorable safety profile for all IL-23 inhibitors.
• Researchers also confirmed the drug's shorter-term safety.