VIENNA (FRONTLINE MEDICAL NEWS) – Updated longer-term safety data for ixekizumab in patients with moderate to severe plaque psoriasis continue to show no new safety signals, Alexa B. Kimball, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

The safety database now includes 4,213 psoriasis patients on ixekizumab (Taltz) for a total of 7,843 patient-years of regular ongoing follow-up in seven different phase I-III clinical trials. And with a large group of patients now having been on the novel humanized monoclonal antibody targeting interleukin-17A for 2 years and smaller numbers out to 5 years, there have been no surprises, according to Dr. Kimball, professor of dermatology at Harvard Medical School, Boston.

“This is a very reassuring safety profile. I think the take-aways from these data are the same ones we heard at the beginning of the ixekizumab program: That oral candidiasis is something that we have to look out for. We are watching the IL-17 pathway and its effect on Crohn’s disease, so that’s part of the family history I take now, but certainly there’s no particular concern showing up in this safety update,” she said.

The key trends in the safety analysis are that the number of patients with an adverse event resulting in ixekizumab discontinuation is very low, yet adverse event rates are declining over time.

“This is pretty common in clinical trials,” according to the dermatologist. “In those first 12 weeks of a study you are seeing the patients very frequently, asking them very detailed questions, and we often pick up adverse events more frequently as a result. Upper respiratory infections are a good example: In the first month a patient will remember what happened last week. But if you haven’t seen a patient in 3 months they might not remember that 10 weeks ago they had a little cold. That’s why we tend to see URI rates go down over time. Now, if you see adverse events go up over time – especially for things like malignancy – then there is certainly cause for concern that there’s a cumulative problem with toxicity. That is clearly not a problem with this drug.”

Turning to selected adverse events of interest, Dr. Kimball noted that 2.1% of patients have experienced oral candidiasis while on ixekizumab.

“Oral Candida infection is one of the known side effects with this drug. It doesn’t happen very frequently, and to date, the infections have been very manageable, but it is something you want to have in your mind because it does happen,” she noted.

Serious infections have occurred in 105 patients, 2.5% of those on ixekizumab. Major adverse cardiovascular events have occurred in 1.0%, nonmelanoma skin cancers in 0.7%, and other cancers in 1.1%. Of note, only 5 patients (0.1%) have developed Crohn’s disease, 10 have been diagnosed with ulcerative colitis, and there have been no completed suicides.

The safety follow-up is ongoing.

The safety registry is supported by Eli Lilly, which markets ixekizumab. Dr. Kimball reported receiving research funding from and serving as a consultant to Eli Lilly and numerous other pharmaceutical companies.


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