Ixekizumab administered for 5 years demonstrated high efficacy and a favorable safety profile in patients with moderate to severe psoriasis

Ixekizumab in the treatment of plaque psoriasis

For patients suffering from moderate to severe plaque psoriasis, long-term therapy is needed to achieve satisfactory control of disease activity and symptoms. A modern therapeutic option for moderate to severe forms of plaque psoriasis is anti-inflammatory targeted biological therapy.

Ixekizumab is a humanized monoclonal antibody that binds with high affinity and specificity to interleukin 17A, which plays an important role in the pathophysiology of the disease, specifically in supporting the proliferation and activation of keratinocytes. The efficacy and safety of the drug has been evaluated in a number of clinical studies, including the UNCOVER-1/-2/-3 series. The study cited below evaluated the efficacy and safety of ixekizumab administration over a 5-year period in patients who participated in the UNCOVER-1 study.

Methodology and course of the study

Participants included in the extension of the UNCOVER-1 study were patients who were evaluated as responders (sPGA 0/1) at week 12 and subsequently completed the initial 60-week double-blind phase of the study. A total of 110 participants met the inclusion criteria. The dosage of ixekizumab was standard: patients first received an initial dose of 160 mg, followed by 80 mg every two weeks up to week 12, and then maintenance therapy with 80 mg every 4 weeks. The dose could be increased between weeks 60 and 264 to achieve or maintain clinical efficacy, but these patients were not included in the cited analysis.

The primary objectives of the study included evaluating the number of patients who achieved an sPGA score of 0/1 or a 75%, 90%, and 100% improvement in the Psoriasis Area and Severity Index (PASI 75/90/100).

Results

The rate of achieving PASI 75/90/100 scores at the start of long-term follow-up (week 60) was 92.7%, 82.7%, and 56.4%, respectively. At the end of the study, the PASI 75/90/100 scores were maintained, specifically achieving rates of 94.3%, 81.8%, and 46.6% (measured using the mNRI method - modified non-responder imputation). Similar results were achieved for sPGA(0/1) responders − at the end of the study, 80% of patients remained in this category, which is only a few percent less than at the beginning.

Adverse events were observed in 99 patients (incidence rate [IR] 31.0 per 100 patient-years), with 24 patients experiencing serious adverse events (IR 7.5); no deaths were observed during the study. The most common adverse events were infections, recorded in 83 patients, including 1 case of candidiasis. Injection site reactions occurred in 4 patients.

Conclusion

The results of the 5-year observation suggest that ixekizumab is a highly effective drug in the treatment of moderate to severe plaque psoriasis with a favorable safety profile even with long-term administration.

(holi)

Source: Leonardi C., Foley P., Torii H. et al. Ixekizumab demonstrates high sustained efficacy and a favorable safety profile in patients with moderate to severe psoriasis through five years of treatment. 24^th World Congress of Dermatology, Milan, 2019 Jun 10−15. Available at: www.wcd2019milan-dl.org/abstract-book/documents/late-breaking-abstracts/35-psoriasis/ixekizumab-demonstrates-high-sustained-efficacy-548.pdf