Kim A. Papp
Patients with moderate-to-severe psoriasis treated with ixekizumab showed high rates of improvement and no unexpected safety outcomes for up to 5 years of treatment, according to study results presented at World Congress of Dermatology in Milan.
Kim A. Papp, MD, PhD, FRCPC, a clinical investigator in the study, discussed the results of the extension period of UNCOVER-1 with Healio Dermatology. Papp is a principal investigator with K. Papp Clinical Research and founder and resident of Probity Medical Research.
“Seeing that you can have a very durable response in a reasonably large cohort of patients up to 5 years is very telling,” Papp said. “Our results may convince some [clinicians] using agents that do not demonstrate this durable response to reconsider how they treat patients. For those familiar with biologics, or even ixekizumab, this reinforces the confidence that they have in the product. We now have a demonstration; we can see a durable response in a cohort of patients which is reflective of the patients we see in clinic.”
Patients continuously received ixekizumab (Taltz, Eli Lilly) through week 60 initial dose 160 mg through week 12 every 4 weeks thereafter.
A 110 patients were eligible for the extension period as they completed 60 weeks of treatment and were identified as static Physician’s Global Assessment (sPGA) 01 responders at week 12.
During weeks 60 to 264, patients (20.9%) elected to escalate dosing to every 2 weeks.
At week 60, was achieved in 92.7% of patients, PASI 90 was achieved in 82.7% and PASI 100 in 56.4%
The response rates were maintained through week 264, PASI 75 was achieved in 94.3% of patients, PASI 90 in 81.8% and PASI 100 in 46.6%.
Treatment-emergent adverse events occurred during weeks 60 to 264 in 99 patients (incidence rate = 31) and 24 events were serious (incidence rate = 7.5)
“Not only does the drug maintain response very well, but we don’t see real noise in safety signals,” Papp told Healio Dermatology. “The adverse events seen in the beginning of treatment at a few months, are not amplified or really changed in any way over time. At 5 years, we ext to see the exact same things we saw in the first 3 or 4 months, which is very telling and supportive and speaks to the integrity of the study.” – by Abigail Sutton
Leonardi C, et al. Ixekizumab demonstrates high sustained efficacy and a favorable safety profile in patients with moderate-to-severe psoriasis through five years of treatment. Presented at: 24th World Congress of Dermatology; June 1015, 2019; Milan.
Disclosure: Papp is a consultant and speaker for Eli Lilly and an investigator for a number of studies and products.