Pegylated tumor necrosis factor-α inhibitor certolizumab improved psoriasis severity in patients with psoriasis and psoriatic arthritis, according to multicenter Italian study data published in the Journal of the European Academy of Dermatology and Venereology.
The study was a retrospective analysis of patient data from 11 Italian sites. Data were obtained for patients with psoriasis and psoriatic arthritis who were treated with subcutaneous certolizumab 400 mg at 0, 2, and 4 weeks, then certolizumab 200 mg every 2 weeks for up to 52 weeks.
The primary outcome included the mean change in the Psoriasis Area and Severity Index (PASI) and the mean change in the modified Nail Psoriasis Severity Index (mNAPSI) scores from baseline. In addition, the researchers assessed the proportion of patients who achieved a 75%, 90%, and 100% reduction in the PASI score (PASI75, PASI90, and PASI100, respectively) during the 52-week treatment period.
A total of 153 patients (mean age, 55 years) with mean psoriasis and psoriatic arthritis durations of 16.3 years and 8.8 years, respectively, were included in the study. Previous treatment with methotrexate was reported in 85% of patients. The mean baseline PASI score was 8.73.
In certolizumab-treated patients at weeks 12, 24, and 52, the mean PASI scores were reduced by -4.45, -6.30, and -7.58, respectively (P <.001 for all). Approximately 29% of patients achieved PASI75 at week 12 compared with 19% who achieved PASI90 and 19% who achieved PASI100 at the same time point.
The mean values for Tender Joint Count and Swollen Joint Count significantly decreased from baseline to weeks 12, 24, and 52 (all P <.001). Treatment with certolizumab was associated with reductions in mean pain visual analogue scale (VAS) scores from baseline to weeks 12, 24, and 52 (all P <.001). In addition, a significant decrease was observed for mean C-reactive protein levels from baseline to week 24 (P =.002). Approximately 14% of patients experienced a treatment-emergent adverse event, but no serious adverse events occurred during the study.
According to a multivariate analysis, significant predictors of PASI score improvements from baseline to week 12 included psoriasis duration (P =.002), baseline PASI (P <.0001), baseline mNAPSI (P =.047), and baseline pain-VAS (P <.0001).
Limitations of this study included its retrospective design and small sample size, the researchers concluded.
In spite of its limitations, this study indicated that “certolizumab provided rapid and sustained improvements in psoriasis and joint symptoms and was well tolerated” in a routine clinical practice.
Disclosure: This clinical trial was supported by UCB. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Dattola A, Balato A, Megna M, et al. Certolizumab for the treatment of psoriasis and psoriatic arthritis: A real-world multicentre Italian study [published online May 13, 2020]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.16606