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Certolizumab: Long-term safety and efficacy results for psoriasis-related nail disease

Presented by
Prof. Andrew Blauvelt, Oregon Medical Research Center, USA
SPIN 2019
Phase 3, CIMPASI
Pooled 48-week data from CIMPASI-1 and CIMPASI-2 phase 3 trials showed total nail disease resolution for approximately two-thirds (66.2%, n=133) of moderate-to-severe psoriasis patients with nail disease [1]. In addition, long-term safety data in psoriasis patients was presented. Lastly, dose escalation or continued treatment with 400 mg of certolizumab pegol every 2 weeks were shown to be effective treatment strategies for psoriasis patients who do not adequately respond to initial treatment.

The impact of certolizumab on nail disease in psoriasis patients was presented for the first time at SPIN 2019. Certolizumab pegol is a humanised antigen-binding fragment (Fab) of a monoclonal antibody that has been conjugated to polyethylene glycol. Certolizumab differs from other TNFα inhibitors in its lack of an Fc region, which minimises potential Fc-mediated effects such as complement-dependent cytotoxicity or antibody-dependent, cell-mediated cytotoxicity and is thought to be a factor in the prevention of active transfer of certolizumab pegol across the placenta during pregnancy [2].

Pooled 96-week safety data from the ongoing phase 3 certolizumab psoriasis trials, i.e. CIMPASI-1, CIMPASI-2, and CIMPACT, confirmed the long-term safety of certolizumab pegol in the treatment of psoriasis. In the 995 patients treated with at least one dose of certolizumab pegol for up to 96 weeks, no new safety signals were observed, and the safety profile was consistent with other anti-TNFs in psoriasis. The overall incidence of adverse events of interest was low; observed incidence rates of adverse events after 16 weeks were comparable for certolizumab pegol and placebo, and risk for adverse events did not appear to increase with longer exposure to certolizumab pegol up to 96 weeks (see Table).

Table: Overview of adverse events and serious adverse events to week 96 [1]

Furthermore, findings from the phase 3 CIMPACT study demonstrated the efficacy of continued certolizumab pegol treatment for psoriasis patients who were partial responders (i.e. PASI≄50<75) or inadequately responded (i.e. did not achieve PASI-75) in the first 16 weeks of treatment. The results showed an important improvement in PASI-75, PASI-90, and PGA 0/1 response rates during an additional 32 weeks of treatment with 400 mg of certolizumab pegol every 2 weeks, both for patients who increased their dosing regimen from 200 mg of certolizumab pegol or those who remained on the dose regimen of 400 mg of certolizumab pegol every 2 weeks. These data emphasise the importance of finding the right treatment regimen for individual psoriasis patients, and that certolizumab pegol is a potential effective long-term option for patients that inadequately responded in the first few months of their treatment.

    1. Blauvelt A, et al. P032, SPIN 2019, 25-27 April, Paris, France.

    2. Clowse MEB, et al. Arthritis Rheumatol. 2018 Sep;70(9):1399-1407.


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