UCB’s long-acting anti-tumour necrosis factor therapy Cimzia is effective in the treatment of moderate-to-severe psoriasis, according to Phase II trial results.
The 176-patient study suggested that Cimzia (certolizumab pegol) is highly effective in psoriasis, based on the widely used Psoriasis Area and Severity Index (PASI) 75 measure, which is achieved when patients experience a 75% improvement in skin symptoms.
When given at an initial dose of 400mg followed by 200mg given by subcutaneous injection every other week for 12 weeks, Cimzia achieved a PASI 75 response in 75% of patients, rising to 83% if 400mg was given throughout the course of treatment. Just 7% of those on placebo experienced a similar improvement.
24-week follow-up period to this study is currently ongoing, with a retreatment study also in progress.
Cimzia been submitted for approval in Europe and the USA as a treatment for Crohn’s disease, with a launch expected in the first half of 2007, and is also in development for rheumatoid arthritis.
Other biologics already approved for treating psoriasis include Biogen Idec’s Amevive (alefacept) and Serono/Genentech’s Raptiva (efalizumab), while among the anti-TNF drugs Wyeth and Amgen’s Enbrel (etanercept) and Johnson & Johnson/Schering-Plough’s Remicade (infliximab) have been approved for this indication, and Abbott Laboratories’ Humira (adalimumab) is being tested in clinical trials for psoriasis.
Despite their clear clinical efficacy, most patients with moderate to severe psoriasis still do not receive treatment with biologics, in part because of the high cost of treatment and reimbursement issues but also a lack of data on long-term follow-up and safety concerns, including the potential for increased infection and malignancy.
Less than half of patients with severe psoriasis in the USA receive aggressive treatment using either systemic drugs, biologic agents or phototherapy.