Real-Life, Long-Term Data Show Ixekizumab Safe, Effective in Psoriasis

Piergiorgio Malagoli, MD

A new multicentric investigation from Italy considered ixekizumab to be a safe long-term therapeutic option for patients with moderate to severe psoriasis, which was supported by rapid clinical responses in most patients.

In recent years, several biologic therapies have been approved for the treatment of moderate to severe psoriasis. Ixekizumab in particular has been shown to reduce inflammation levels and led to other clinical improvements.

While the long-term efficacy and safety of the medication has been investigated before, few studies have been based on real life experience.

For this study, investigative team led by Piergiorgio Malagoli, MD, Department of Dermatology at the Dermatology Unit of San Donato Milanese Hospital in Milan, reported on an Italian real-life multicentric experience pertaining to the long-term efficacy and safety profile of ixekizumab for up to 4 years.

A total of 11 psoriasis centers from Italy were included in the report. These centers offered a total of 779 patients with moderate to severe psoriasis who had started ixekizumab therapy between 2017 and 2020 without discontinuation and had reached at least 2 years of continuative treatment.

All patients received 2 subcutaneous injections at week 0 (160 mg) followed by 1 injection (80 mg) every 2 weeks for the first 12 weeks. Following the end of the induction dose, patients received 80 mg of ixekizumab every 4 weeks in the maintenance regimen.

The team treated 484 males and 295 females, with 49 patients ending treatment after at least 2 years due to adverse events, primary inefficacy, or loss of efficacy of ixekizumab.

Approximately 205 patients (26.32%) had active psoriatic arthritis at baseline and were not being treated with biologics, while 454 (58.23%) were naïve to all biologics.

The average PASI score at baseline was 16.55, while average PASI at 48, 96, 144, and 192 weeks were 0.57, 0.58, 0.37, and 0.17, respectively.

Among the 779 patients, 121 (15,53%) hadnailpsoriasis,111 (14,25%) had genital involvement,196 (25,16%) had psoriasis of the scalp, and 110(14,12%) had palmo-plantar involvement.

Investigators observed that 779 patients included in the retrospective observational study achieved an optimal clinical response through 2-4 years of follow-up when comparing both the safety and efficacy profile to the UNCOVER 1 and UNCOVER 3 randomized clinical trials.

The team also noted that, , based on the data and inthewidestreal-life experience regarding the biologic, ixekizumab could lead to a rapid but also progressive" improvement of theaverage PASI and also of patients’ satisfaction, measured by average DLQI.

"We can consider ixekizumab as a safe inhibitor of IL-17 characterized by a rapid clinical response, but also with a long-term efficacy observed by randomized clinical trials and confirmed by our real-life experience," the team wrote.

The study, "Real life long-term efficacy and safety of ixekizumab in moderate-to-severe psoriasis: a 192 weeks multicentric retrospective study – IL PSO (ITALIAN LANDSCAPE PSORIASIS)," was published online in Dermatologic Therapy.