Remicade approved for use in psoriasis

The licensed indications for Schering Plough's monoclonal antibody Remicade (infliximab) have been extended to include the treatment of moderate to severe plaque psoriasis in adults who have failed to respond to, have a contraindication to, or are intolerant of other systemic therapies, including ciclosporin, methotrexate or PUVA.

The recommended dose of Remicade in psoriasis is 5mg/kg by intravenous infusion over two hours, repeated two and six weeks later and then every eight weeks thereafter. If the patient shows no response after 14 weeks, no additional doses should be given.

Remicade is available as powder for concentrate for solution for infusion presented in vials containing infliximab 100mg.

Remicade is also licensed for use in rheumatoid arthritis, Crohn's disease, ankylosing spondylitis and psoriatic arthritis; see the eMIMS records for more information.

Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFa but not to lymphotoxin a (TNFß). In psoriasis patients, treatment with infliximab resulted in decreases in epidermal inflammation and normalisation of keratinocyte differentiation in psoriatic plaques.

Infliximab has been evaluated in two randomised controlled trials involving patients with plaque psoriasis with a body surface area >10 per cent and a Psoriasis Area and Severity Index (PASI) score >12 who had previously received PUVA or systemic therapy. The primary endpoint in both studies was the percentage of patients who achieved >75 per cent improvement in PASI from baseline at week 10.

In the first trial (n=249) patients received infliximab 3mg/kg or 5mg/kg at 0, 2 and 6 weeks. The proportion of patients achieving PASI 75 at week 10 was 71.7 per cent, 87.9 per cent and 5.9 per cent in the 3mg/kg, 5mg/kg and placebo groups, respectively. At week 26, 30 per cent of patients in the 5mg/kg group and 13.8 per cent of those in the 3mg/kg group were PASI 75 responders. Psoriasis symptoms gradually returned between weeks 6 and 26 (median time to relapse >20 weeks). No rebound was observed.

In the second trial (n=378) patients received infliximab 5mg/kg or placebo at weeks 0, 2 and 6, followed by maintenance infusions every eight weeks through week 22 in the placebo group and through week 46 in the infliximab group. Patients in the placebo group switched to active therapy at week 24.

In the infliximab group PASI 50 responses were apparent by week 2 and PASI 75 responses by week 6. The proportion of patients achieving PASI 75 at week 10 was 80.4 per cent in the infliximab group compared with 2.6 per cent in the placebo group (p<0.001). By week 50, 76.5 per cent of patients in the placebo group and 60.5 per cent of patients in the infliximab group had achieved PASI 75.

View Remicade drug record

Further Information: Schering Plough Ltd

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