At weeks 12 and 24, the proportion of patients reporting high disease activity reduced from 16.7% to 8.3%, respectively.
Patients with psoriatic arthritis (PsA) receiving ixekizumab treatment in a real-world setting had high treatment persistence through 104 weeks, as well as improvements in disease activity post-treatment initiation, according to a study published in Rheumatology and Therapy.1
Ixekizumab, indicated alone or with concomitant methotrexate, is used to treat adult patients with PsA with an inadequate response or intolerance to ≥1 disease-modifying antirheumatic drugs (DMARDs).
The management of this patient population often requires the cooperation of both rheumatologists and dermatologists with a goal of controlling inflammation to preserve the functional capacity and maximizing health-related quality of life. Treatments generally include conventional synthetic DMARDs (csDMARDs), biologic DMARDs (bDMARDs), and targeted synthetic DMARDs (tsDMARDs).2
“Ixekizumab has shown efficacy and safety in biologic-naïve PsA patients (SPIRIT P1) and in those previously exposed to anti-TNF (SPIRIT P2), and it has shown superiority to adalimumab in a combined outcome reaching a 100% improvement in Psoriasis Area and Severity Index score (PASI100) + a 50% improvement in the American Colleague Rheumatology criteria (ACR50) (SPIRIT H2H) in biologic-naïve PsA patients,” wrote a group of Spanish investigators. “Currently, the real-world evidence (RWE) available in the literature is still limited.”
In the observational, retrospective, longitudinal, multicentric PRO-STIP study, investigators aimed to evaluate the efficacy, persistence, treatment patterns, and patient characteristics of Spanish patients with PsA treated with ixekizumab in a real-world clinical setting between January 2019 and December 2020. Patients were followed up at a minimum of 24 weeks, and patient characteristics and treatment patterns were analyzed during this time.
The primary endpoint was treatment persistence during a minimum of 24 weeks, which was determined by Kaplan–Meier survival curve. The effectiveness of the disease was assessed by the Disease Activity in Psoriatic Arthritis (DAPSA) scores at baseline, 12 weeks, and at 24 weeks.
A total of 89 patients were included in the study, of which 55.1% were female, the mean age was 51.5 years, and the median time from PsA diagnosis to ixekizumab initiation was 7.7 years. Prior to initiation, most (95.5%) patients were treated with ≥1 b/tsDMARDs.
Persistent rates at weeks 24, 48, and 104 weeks were 95.5%, 84.3%, and 68.5%, respectively. Because ≤50% of patients discontinued treatment at the end of the follow-up, the median persistence was not achieved. The mean persistence was 86.9 weeks (95% confidence interval [CI] 80.6 – 93.2) and 75% of patients were persistent at 71.9 weeks (95% CI 68.0 – 75.8). A third of patients (n = 28, 31.5%) discontinued treatment, with 19 reporting a loss of effectiveness and 2 patients stopping due to adverse events.
Among patients treated with ixekizumab with an available effectiveness assessment (n = 24), the DAPSA significantly decreased from baseline (23.7 [95% CI 19.5–27.9]) to 12 weeks (14.8 [95% CI 11.1 – 17.4]) and 24 weeks (14.3 [95% CI 11.1 – 17.4]; P = .004). At weeks 12 and 24, the proportion of patients experiencing high disease activity reduced from 16.7% to 8.3%, respectively.
Investigators noted the retrospective study design, which included missing values and inconsistences within medical records, as a limitation of the study. Although clinical characteristics and demographics were accounted for in the sample, the effectiveness data were only collected in a small proportion of patients. Therefore, results should be interpreted with caution. Additionally, the results may not be generalizable to the entirety of clinical practice across Spain, although it accurately represents the variability of 8 centers across the country.
“PRO-STIP is the first multicenter study that has evaluated ixekizumab treatment effectiveness, persistence, and treatment patterns in PsA patients in routine clinical practice in Spain, with the RWE study involving a higher number of patients at European level assessing these 3 objectives,” investigators concluded. “Improvements in disease activity measured with DAPSA at 12 and 24 weeks suggest that ixekizumab could be an effective treatment.”