Studies Confirm Positive Long-Term Safety Profile of CIMZIA

| By | CIMZIA, psoriasis, UCB

UCB, a global biopharmaceutical company, today announced new data supporting the long-term safety of CIMZIA® (certolizumab pegol), the only Fc-free, PEGylated anti-Tumor Necrosis Factor (TNF), in patients with moderate-to-severe plaque psoriasis, and new efficacy data for patients who show signs of psoriasis-related nail disease and those who had an inadequate early treatment response to CIMZIA. These findings are being presented at the 6th Congress of the Skin Inflammation & Psoriasis International Network (SPIN), in Paris, April 25-27, 2019.  

“This new research demonstrates UCB’s ongoing commitment to delivering meaningful outcomes for psoriasis patients, where there is still significant unmet need. This includes patients with psoriatic nail disease and those who do not initially adequately respond to their treatment dose. The multitude of evidence from these ongoing trials complements data from across all areas of chronic inflammatory diseases to show the value of CIMZIA in treating different patient populations,”

said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB.

Results include pooled 96-week safety data from the ongoing Phase 3 CIMZIA psoriasis trials, CIMPASI-1, CIMPASI-2 and CIMPACT, confirming the long-term safety of CIMZIA in the treatment of psoriasis. In the 995 patients treated with at least one dose of CIMZIA 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 CIMZIA and placebo and risk for adverse events did not appear to increase with longer exposure to CIMZIA up to 96 weeks.

The impact of CIMZIA on nail disease in psoriasis patients was presented for the first time at SPIN. While CIMZIA use in psoriatic arthritis (PsA) has demonstrated to be efficacious in nail disease, nail outcomes for CIMZIA in psoriasis have not previously been reported. 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 psoriasis patients with nail disease. Results were consistent for patients on either CIMZIA dose regimen and CIMZIA demonstrated similar efficacy in treating nail disease in psoriasis patients with and without concomitant PsA.

Finally, findings from the Phase 3 CIMPACT study demonstrated the efficacy of continued CIMZIA treatment for psoriasis patients who were partial responders (PASI≥50<75) or inadequately responded (did not achieve PASI75) in the first 16 weeks of treatment. The results showed an important improvement in PASI75, PASI90 and PGA 0/1 response rates during an additional 32 weeks of treatment with 400mg of CIMZIA every two weeks both for patients who increased their dosing regimen from 200mg of CIMZIA or those who remained on the dose regimen of 400mg of CIMZIA every two weeks. These data emphasize the importance of finding the right treatment regimen for individual psoriasis patients, and that CIMZIA is a potential effective long-term option for patients that inadequately responded in the first few months of their treatment.

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