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Certolizumab pegol efficacious for head and neck psoriasis

Presented by
Prof. Peter van de Kerkhof, Radboud University, the Netherlands
EADV 2019
Phase 3, CIMPASI-1 and CIMPASI-2
A pooled analysis of the phase 3 CIMPASI-1 and CIMPASI-2 studies with focus on psoriasis of head and neck showed that certolizumab pegol, an anti-TNFα monoclonal antibody, in a dose of 400 mg every second week leads to greatest improvement of this difficult-to-treat area [1].

The new assessment included data from 461 adult patients with moderate-to-severe psoriasis from the CIMPASI-1 and CIMPASI-2 trials. The analysis focussed on the head and neck was chosen, as visible psoriasis in these areas has a disproportionately high impact on patients’ quality of life [2].

Inclusion criteria also included a Psoriasis Area and Severity Index score (PASI) of ≥ 12, body surface area (BSA) ≥ 10%, and Physician's Global Assessment (PGA) of ≥ 3 at baseline. Randomisation allocated 186 patients to the group treated with 200 mg certolizumab pegol every second week, 175 patients receiving 400 mg certolizumab every second week, and 100 patients to placebo. The initial treatment within the RCTs lasted over 16 weeks. All study participants reaching at least a 50% improvement of PASI (primary study endpoint) continued maintenance at the previous dosage through week 48. Co-primary endpoints were: PASI75 defined as responder rate along with PGA of 0/1 and improvement of ≥ 2 points.

The post-hoc analysis analysed achievement of 75% and 90% improvement of psoriatic lesions on head and neck and the mean difference from baseline in these locations. Mean score values for PASI on head and neck before treatment were 2.1 in the lower certolizumab dose group, 2.4 in the higher dose group, and 2.4 in the placebo group.

At week 16, 80% of the patients taking the higher dose of certolizumab and 70.4 % of those in the 200 mg certolizumab group reached PASI 75 on head and neck, compared with 14.9% of the patients on placebo (see Figure). Rates for PASI 90 were 70.3%, 56.8%, and 9.3%, respectively. Response was lasting through week 48 with changes from baseline of -88.3% with the 400 mg dose and -76.5% with the 200 mg dose. All in all, these results indicate that certolizumab is an effective treatment for head and neck psoriasis.

Figure: Improvements in PASI of the head and neck region through weeks 0-48 [1]PASI, Psoriasis Area and Severity Index; CZP, certolizumab.

    1. Van de Kerkhof P et al. P1617, EADV 2019, 9-13 Oct, Madrid, Spain.
    2. Merola JF, et al. Dermatol Ther. 2018;31:e12589.

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