Further evidence for efalizumab in plaque psoriasis
Efalizumab, a humanised monoclonal antibody recently approved in the US for treatment of patients with chronic moderate to severe plaque psoriasis (PJ, 13 December 2003, p807), has shown further evidence of efficacy.
In a phase III double-blind trial, 556 patients with moderate to severe
plaque psoriasis were randomly assigned to receive 12 weekly doses of
subcutaneous efalizumab 1mg/kg or placebo. The efalizumab-treated patients
experienced reduced frequency and severity of psoriasis symptoms, particularly
in the severity of itching and scaling. In the efalizumab group, 27 per
cent of patients achieved at least 75 per cent improvement on the psoriasis
area and severity index, compared with 4 per cent in the placebo group.
Katrina Simister, assistant director, new medicines scheme, at the National
Prescribing Centre, Liverpool, told The Journal: “Trials comparing
the drug to existing standard treatments, for example, methotrexate,
ciclosporin or systemic retinoids, would help define its place in therapy.
Compelling evidence of long-term efficacy and safety data would seem
prudent before these ‘biologic’ agents are used on a widespread
basis.
“However, they may have a role in treating some individuals who
have moderate to severe disease and who are either unresponsive, or have
developed
toxicity to other therapeutic options.”
Efalizumab was shown to be generally well tolerated, with serious adverse
effects occurring in 2 per cent of patients compared with 1 per cent
of placebo-treated patients. The most commonly occurring adverse events
during the initiation of efalizumab were mild to moderate flu-like symptoms
following the first one or two injections (JAMA 2003:290;3073). |
The
Pharmaceutical Journal