Beyond the Joints and Skin: Sustained Improvement in EAMs with CZP Over 4 Years

New long-term data supporting the maintenance of efficacy of certolizumab pegol (CZP) for extra-articular manifestations of PsA were reported from the RAPID-PsA trial at EULAR today. A poster by FitzGerald et al (#FRI0508) confirms that the rapid improvement in enthesitis, dactylitis and nail psoriasis with CZP is maintained at 216 weeks, regardless of whether patients were naïve to treatment or had previously received anti-TNF therapy.

RAPID-PsA is a large phase 3 trial that examined the efficacy and safety of CZP in patients with active PsA. Four-year results from an open-label extension of this trial were reported at EULAR in 2016 for the main clinical outcomes in the joints and the skin, namely ACR and PASI responses.

Effective treatment of PsA must go beyond the joints and the skin. That's because extra-articular manifestations (EAMs) are common in patients with PsA, and they can be painful and debilitating leading to serious impairment in quality of life. That makes resolution of EAMs an important goal of treatment.

The effects of CZP treatment on EAMs was prospectively evaluated in RAPID-PsA. Patients with enthesitis, dactylitis and/or nail involvement at baseline were assessed using the Leeds Enthesitis Index (LEI), Leeds Dactylitis Index (LDI), and the modified Nail Psoriasis Severity Index (mNAPSI) for enthesitis, dactylitis, and nail psoriasis, respectively. These EAMs were common in the RAPID-PsA cohort, with >70% having nail involvement, >60% having enthesitis, and >25% with dactylitis at baseline.

There was a rapid improvement in each of these EAMs in patients treated with CZP regardless of prior exposure to anti-TNF agents. Improvements were evident early after treatment was initiated and the effects were maintained to 216 weeks. Improvements seemed to plateau after ~48 weeks for enthesitis, ~24 weeks for dactylitis, and ~72 weeks for nail psoriasis. A substantial proportion of patients achieved total resolution of EAMs, with rates reaching ~70% for enthesitis (LEI score = 0), ~75% for dactylitis (LDI score = 0), and ~60% for nail psoriasis (mNAPSI score = 0) (data imputed using last observation carried forward).

These data support the RAPID effect of CZP across a variety of tissues affected in patients with PsA. Importantly, these beneficial effects were observed early and were maintained out to 4 years of treatment, regardless of previous exposure to anti-TNF agents.

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