Ixekizumab is effective in the long-term management in moderate-to-severe plaque psoriasis: results from an Italian retrospective cohort study (the LOTIXE study)

Abstract

Purpose

Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A approved for the treatment of moderate-to-severe plaque psoriasis. The objective of this study was to describe the real-world long-term effectiveness of ixekizumab in patients with plaque psoriasis in Italy.

Materials and Methods

A retrospective study was conducted in patients affected by moderate-to-severe plaque psoriasis who were continuously treated with ixekizumab for at least 12 months. Patient data was obtained at 4-weeks, 12-weeks and 6-, 12-, 18- and 24-months after baseline (June 2017 and September 2019) from 10 sites. Results were analyzed by complete case approach, with sensitivity analysis performed to evaluate the impact of missing data.

Results

A total of 198 patients were enrolled in the study. At Month 24, 94.3% of patients achieved PASI75 response, while 85.1 and 71.8% achieved PASI90 and PASI100, respectively; and 91.1% of the patients achieved absolute PASI score ≤2. Patients experienced psoriasis improvement at 4 weeks after starting treatment, and improvement was maintained with continued ixekizumab use. The quality of life of patients also improved significantly starting at Week 12, with sustained effect in the long term.

Conclusion

This 24-month observational cohort study confirmed that ixekizumab is effective in the long-term management of patients with moderate-to-severe plaque psoriasis.

Keywords:

• Ixekizumab
• plaque psoriasis
• psoriasis
• autoimmune disease
• IL-17A inhibitor
• real-world evidence

Acknowledgements

The authors would like to thank the participants for their participation and cooperation. The authors would also like to thank OPIS s.r.l. for conducting the study on behalf of the sponsor. Manuscript writing assistance in the preparation of this article was provided by Chu-Han Huang from OPIS s.r.l.

Disclosure statement

A. Chiricozzi has served as advisory board member and consultant and has received fees and speaker’s honoraria or has participated in clinical trials for Eli Lilly. A. Balato has served as board participant or speaker for Eli-Lilly. A. Narcisi has served on advisory boards, received honoraria for lectures and research grants from Eli Lilly. A. Giunta served as consultant, board member and speaker for and/or received research grants from Eli Lilly. P. Dapavo has acted as a speaker or consultant for Eli Lilly. G. Carrera has served as a board participant or speaker for Eli Lilly. A. Parodi and S. Mazzoccoli have reported conflicts of interests with Eli Lilly. C. Buzzoni and S. Sabatino are employed and minor shareholders at Eli Lilly. No potential conflict of interest was reported by the author(s).

Data availability statement

The data that support the findings of this study are available from the corresponding author, C.B., upon reasonable request.

Additional information

Funding

This work was funded by Eli Lilly Italy S.p.A.