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Following on from Cimzia (certolizumab pegol) getting approval for the treatment of Psoriatic Arthritis (PsA) in USA, UK, & Ireland See Here: Cimzia gets FDA approval for psoriatic arhtritis
Phase 3 clinical trial data has been presented at the 23rd Congress of the European Academy of Dermatology and Venereology (EADV)
Phase 3 clinical trial data has been presented at the 23rd Congress of the European Academy of Dermatology and Venereology (EADV)
Quote:
Treatment with certolizumab pegol showed sustained positive effects on dermatological outcomes over 96 weeks in patients with psoriatic arthritis.
Patients' mean Psoriasis Area and Severity Index (PASI) improved from a score of 12.0 at baseline to 2.6 at week 96.
In addition, a 75% improvement in the PASI score (PASI-75) was seen in 53.0% of patients, and a 90% improvement in the PASI score (PASI-90) was seen in 44.0% of patients over the study period.
The RAPID-PsA trial enrolled adult patients with active psoriatic arthritis who had failed ≥1 disease-modifying anti-rheumatic drugs (DMARDs). In addition, while previous use of a tumour necrosis factor (TNF) inhibitor was allowed for any given patient, the percentage of all patients who had received 1 prior TNF inhibitor could not exceed 40%.
In the first 24 weeks of the study, 409 patients were randomised 1:1 to double-blind treatment with certolizumab 200 mg every 2 weeks, certolizumab 400 mg every 4 weeks, or placebo. Both certolizumab groups initially were given a 400 mg loading dose at weeks 0, 2, and 4.
From week 24 to week 48, a dose-blind period followed, in which patients originally randomised to placebo were re-randomised to certolizumab of either dose. Patients originally randomised to certolizumab continued receiving the same dose. Then from week 48 to week 216, all treatment was open-label, with the same doses being continued. Treatment was administered as a subcutaneous injection.
At week 0, the number of patients randomised to both doses of certolizumab was 273. Of these, 91% completed treatment to week 24, 87% to week 48, and 80% to week 96. A total of 166 of them (60.8%) showed a psoriasis-affected body surface area (BSA) of ≥3% at baseline, with a mean BSA at baseline of 24.2%. Results showed that this group's mean BSA fell to 8.1% at week 24 and then to 6.5% at week 96.
Among these 166 patients, mean PASI score at baseline was 12.0 and this was reduced to 2.7 at week 24 and 2.6 at week 96. Treatment response was also assessed by how many of them reached PASI-75 (61.4% at week 24 and 53.0% at week 96) and PASI-90 (41.6% at week 24 and 44.0% at week 96). In addition, 22.9% of these patients received a rating of "clear" on the Physician’s Global Assessment of Psoriasis (PGA) scale at week 24, which improved to 30.7% at week 96.
Among all patients, the Dermatology Life Quality Index (DLQI) score fell by 5.8 points at week 24 and by 6.0 points at week 96 compared with baseline levels, indicating an improvement in the patient's own assessment of their quality of life impaired by their psoriasis.
The safety analysis included all patients treated with ≥1 certolizumab dose to week 96 (n = 393). Treatment-emergent adverse events (AEs) were reported in 87.8% of patients (n = 345; event rate per 100 patient-years: 329.8), including 45 that were severe (11.5%). Serious AEs occurred in 17.0% of patients (n = 67; event rate per 100 patient-years: 14.5).
Thirty-six patients (9.2%) discontinued the study due to AEs. While serious infections were reported in 16 patients (4.1%; event rate per 100 patient-years: 3.3), no cases of tuberculosis were found. Six patients died (1.5%).