Schering-Plough Corporation (KENILWORTH, NJ) announced that the European Commission approved the use of REMICADE® (infliximab) as monotherapy in the treatment of active and progressive psoriatic arthritis (PsA) in patients who show intolerance to methotrexate (MTX) or for whom MTX is contraindicated. The new label reflects the clinical efficacy of REMICADE as demonstrated by the improvement in joint involvement and significant skin clearance. REMICADE, in combination with MTX, originally received approval in October 2004 for the treatment of active and progressive PsA in patients who have responded inadequately to disease-modifying antirheumatic drugs.

The REMICADE PsA label extension is based on 1-year data from Infliximab Multinational Psoriatic Arthritis Controlled Trial 2 (IMPACT 2), a phase III clinical study of 200 patients with active PsA, and 2-year data from the original IMPACT Trial, upon which the initial approval of REMICADE in PsA was based. In the IMPACT 2 trial, the primary end point of joint improvement was met in REMICADE-treated patients. At week 54 of treatment, 53% of treated patients achieved an ACR 20 response (a 20% collective improvement in rheumatoid arthritis [RA] symptoms) with 33% and 20% achieving ACR 50 and ACR 70 responses, respectively. Additionally, a Psoriasis Area and Severity Index score of 75 (PASI 75) was seen in 49% of REMICADE-treated patients at week 54. A PASI 75 score reflects a 75% improvement in disease symptoms. In the IMPACT and IMPACT 2 trials, patients treated with REMICADE saw significant improvements in standard measures of disease activity, including number of swollen joints, number of painful and/or tender joints, dactylitis (finger or toe inflammation), and enthesopathy (inflammation involving the attachment of a tendon or ligament to bone). Also, REMICADE-treated patients in both trials saw disease improvement as early as week 2. REMICADE efficacy was demonstrated in both trials, with or without concomitant use of MTX.

In other regulatory approval news related to TNF-blocking agents, Abbott (ABBOTT PARK, Ill) announced that the US Food and Drug Administration (FDA) approved HUMIRAR (adalimumab) for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). AS is the third of six autoimmune diseases targeted for HUMIRA therapy that has received FDA approval. HUMIRA was approved in 2002 by the FDA to treat RA and in 2005 to treat PsA. HUMIRA received European approval to treat patients with severe, active AS on June 1, 2006. Beginning in August, 2006, patients will be able to take advantage of the HUMIRA Pen, a new delivery device for the self-administration of HUMIRA. Approved by the FDA on June 23, 2006, the HUMIRA Pen offers improved ease of use and a less painful experience compared with the HUMIRA pre-filled syringe.
The approval of HUMIRA for the treatment of patients with active AS is based on data from the Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS) trial. ATLAS was a randomized, placebo-controlled, double-blind, phase III study conducted in Europe and the US. Results showed that HUMIRA was successful in reducing pain and inflammation in patients with AS after 12 weeks of treatment, the study's primary end point. Other findings demonstrated significant improvement in measures of disease activity for many patients treated with HUMIRA that were first observed at week 2 and maintained through 24 weeks. ATLAS also explored the impact of HUMIRA on enthesitis, a condition in AS that is characterized by inflammation of the ligaments that attach to the bone. At week 24, the mean change in the enthesitis symptom score as measured by the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in patients treated with HUMIRA showed significant reduction. MASES is an index that assesses enthesitis in certain locations, such as the rib cage, lower back, and Achilles tendons.

—A. Techman

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