Patients with moderate to severe psoriasis self-reported continued improvement in affected body surface area (BSA), itch, and pain with use of ixekizumab over a 24-week evaluation period, according to study results published in Dermatologic Therapy.
A prospective, observational, web-based survey study was conducted in commercially insured patients with a confirmed diagnosis of psoriasis who were enrolled in the US Taltz® Customer Support Program (CSP) from November 2020 to September 2022.
Patients aged 18 years and older completed a baseline survey, and subsequent surveys were emailed to them at weeks 2, 4, 8, 12, and 24. The survey addressed clinical outcomes, disease and treatment impact, the importance of treatment attributes, treatment satisfaction, and demographic and clinical characteristics.
To evaluate clinical outcomes, the researchers also had patients complete the Patient Report of Extent of Psoriasis Involvement (PREPI) questionnaire regarding BSA affected by psoriasis. Itch and skin pain within the previous 24 hours were rated on a single-item, 11-point Numeric Rating Scale. The Patient Global Assessment of Disease Severity (PatGA), Patient-Reported Outcomes Measurement Information System Sleep-Related Impairment (PROMIS SI) Short Form 4a, and Dermatology Life Quality Index (DLQI) were also used in the evaluation. DLQI scores range from 0 to 30, with a score greater than 10 indicating a skin condition severely affecting quality of life and scores of 0 or 1 reflecting no impact or minimal impact.
A total of 523 patients with psoriasis completed the baseline survey and were included in the study. The patients’ mean (SD) age was 47.5 (±12.0) years, 86.2% were White, 63.5% were female, and lived with psoriasis for mean (SD) time of 16.4 (± 13.9) years.
At baseline, 34.5% of patients had psoriasis involvement of 2% BSA or less; this proportion increased to 40.1%, 50.9%, and 79.9% of patients by weeks 2, 4, and 24, respectively. At baseline, 54.8% of patients had BSA involvement greater than 1% and 75.1% had BSA involvement greater than 3% at baseline; by week 12 the patients had met the National Psoriasis Foundation preferred and acceptable target responses of BSA involvement of 1% or less and BSA involvement of 3% or less or BSA improvement of 75% or more, respectively. Preferred and acceptable responses in these 2 patient groups were 64.8% and 78.1%, respectively, by week 24.
A minimal clinically important improvement in itch (by 4 points or more) occurred as early as week 2 in 21.1% of patients and increased to 63.1% at week 24. Regarding skin pain, 28.0% of patients had improvement at week 2 and 64.8% achieved improvement at week 24.
Among the cohort, 13.4% of patients at baseline rated their psoriasis overall as 0 (clear on PatGA) or 1, which improved to 24.1%, 34.0%, and 69.6% at weeks 2, 4, and 24, respectively. At baselin,e 21.6% of patients had PatGA scores of 5 (severe) which fell to 8.7% by week 2, remaining low (2.3%) through week 24.
At baseline, 8.4% of participants reported a DLQI score of 0 or 1; the proportion reporting a DLQI score of 0 or 1 increased to 17.6%, 27.3%, and 53.8% of participants at weeks 2, 4, and 24, respectively.
In summarizing the study findings, the researchers noted, “Patient-reported improvements in BSA, itch, skin pain, dermatology-specific HRQL, sleep, and overall [psoriasis] severity were seen as early as 2 weeks after treatment initiation and continued through week 24.”
Study limitations include the survey design and enrollment through a CSP, which did not allow for comparisons with control groups. Additionally, patients who were insured by public payers (Medicaid, Medicare) were not included. Lastly, attrition during the 6-month study period, which occurred during the COVID-19 pandemic, may have affected the results.
“This study gives context to the real-world benefit of ixekizumab from a patient’s perspective and demonstrates early and sustained clinical and functional improvements similar to those observed in the UNCOVER phase III trials and other real-world studies,” the researchers concluded. They added, “The study also supports the use of a CSP for evaluating treatment benefit for patients with a confirmed diagnosis of [psoriasis] at initiation and over time.”
Disclosure: This research was funded by Eli Lilly and Company. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
This article originally appeared on Dermatology Advisor
Gottlieb AB, Burge R, Malatestinic WN, et al. Ixekizumab real-world effectiveness at 24 weeks in patients with psoriasis: data from the United States Taltz Customer Support Program. Dermatol Ther (Heidelb). 2023;13(8):1831-1846. doi:10.1007/s13555-023-00969-1