Remicade therapy productive in patients treated for chronic plaque psoriasis

Investigators reported today at the American Academy of Dermatology annual meeting that patients with moderate to severe plaque psoriasis receiving REMICADE® (infliximab) induction and maintenance therapy experienced significant improvements in productivity at week 10, which were sustained through week 50.

After 10 weeks, patients receiving REMICADE 3 mg/kg or 5 mg/kg achieved significant improvements in work and daily activities (2.9 and 3.1, respectively, from baseline) compared to little to no improvement (a mean decrease of 0.1) among placebo-treated patients (P < 0.001), as measured by the Productivity Visual Analogue Scale. Psoriasis is an inflammatory disorder characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain and emotional distress. It is estimated that as many as 7.5 million people in the U.S. have psoriasis, which can present in various forms and can range from mild to severe and disabling.

"These findings show a relationship between the significant improvements REMICADE-treated patients experienced in psoriasis and improvements in productivity," said Steven Feldman, M.D., Ph.D., professor of dermatology, pathology and public health sciences, Bowman Gray School of Medicine, Wake Forest University. "Such analyses offer further insight into the impact of this chronic inflammatory disease on patient productivity and the effect of intervening with an appropriate biologic treatment, like REMICADE. We look forward to further studies to identify the economic implications of such productivity analyses in a real-world setting."

In the Evaluation of Infliximab for Psoriasis in a [REMICADE] Efficacy and Safety Study (EXPRESS II), REMICADE-treated patients demonstrated a statistically significant productivity increase of 2.9 and 3.1 in the 3 mg/kg and 5 mg/kg groups, respectively, from baseline compared with a mean decrease of 0.1 with placebo as measured by the Productivity Visual Analogue Scale (P < 0.001). The Productivity Visual Analogue Scale is a 10-cm scale with a score of zero indicating very impaired productivity and a score of 10 indicating no impairment. Baseline productivity scores among the REMICADE 3 mg/kg, REMICADE 5 mg/kg and placebo groups were comparable at 5.7, 5.6 and 5.6, respectively, indicating impaired productivity.

Increased productivity scores paralleled significant improvements in the role-physical domain (RP) and role-emotional domain (RE) scores of SF-36, an eight-domain questionnaire widely used to assess patient health-related quality of life. In EXPRESS II, at baseline, RP scores in the REMICADE 3 mg/kg, REMICADE 5 mg/kg and placebo groups were relatively low compared with the general population (47.5, 46.6 and 44.8, respectively). At week 10, significant mean increases of 4.1 and 5.1 were reported in the REMICADE 3 mg/kg and 5 mg/kg groups, respectively, compared with little increase (0.8) in the placebo group (P < 0.001). At baseline, RE scores were 47.4, 47.8, and 46.4, respectively. At week 10, significant mean increases of 4.8 and 4.4 were reported in the REMICADE 3 mg/kg and 5 mg/kg groups, respectively, compared with little increase (0.9) in the placebo group (P < 0.001).

At 14 weeks, patients in the REMICADE 3 mg/kg and 5 mg/kg induction groups were randomized to receive scheduled treatment every eight weeks or "as-needed" maintenance therapy with REMICADE. Improvement in productivity scores was better maintained in the scheduled dosing groups versus the as-needed dosing group. The greatest productivity improvement through week 50 was seen in the REMICADE 5 mg/kg every-eight-week maintenance group. Additionally, placebo patients who transitioned to REMICADE treatment at week 16 also achieved improvements in productivity through week 50.

Psoriasis is most commonly diagnosed between the ages of 20 and 30, striking in the prime of people's lives, and the extent of skin involvement varies from mild to severe and disabling. People with severe psoriasis may have large areas of their body covered by lesions, which may crack and bleed. The pain and embarrassment associated with such skin lesions may prevent people from participating in social and work-related activities, and the physical and mental effects of psoriasis have been compared to those of other chronic illnesses such as rheumatoid arthritis, hypertension, heart disease, diabetes and depression. Skin lesions associated with psoriasis often result in feelings of sadness, despair, guilt and anger, as well as in low self-esteem. A person's sense of self-worth can be affected, and in some cases, this emotional turmoil can lead to depression.

"This research further illustrates the correlation and impact of psoriasis on work productivity and demonstrates the substantial physical and emotional burdens faced by those living with this life-altering disease," says Gail Zimmerman, president and CEO, National Psoriasis Foundation. "We at the National Psoriasis Foundation encourage continued research and stress the importance of access to effective therapies, which may help manage a disease that often interferes with work and life activities."

In September 2006, REMICADE was approved in the U.S. for the treatment of adult patients with chronic severe (i.e. extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. The recommended dose is an infusion of 5 mg/kg followed by additional doses at two and six weeks after the first infusion and then every eight weeks thereafter.

About EXPRESS II

The Evaluation of Infliximab for Psoriasis in a [REMICADE] Efficacy and Safety Study (EXPRESS II) was a Phase 3, multi-center, randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of REMICADE in 835 adult patients with chronic, stable plaque psoriasis involving at least 10 percent BSA, a minimum PASI score of 12 and who were candidates for phototherapy or systemic therapy. Patients were randomized to induction doses of REMICADE 3 mg/kg or 5 mg/kg or placebo at weeks 0, 2 and 6. Patients in the active induction treatment groups were randomized again at week 14 to receive either scheduled or "as-needed" maintenance treatment at the same dose administered during the induction phase. Patients in the placebo group were crossed over at week 16 to receive REMICADE 5 mg/kg at weeks 16, 18 and 22, then every 8 weeks through week 46.

In EXPRESS II, through week 14 (the placebo-controlled period), adverse events (AEs) occurred at a higher incidence in the REMICADE groups (63 percent and 69 percent with 3 mg/kg and 5 mg/kg, respectively), compared with the placebo group (56 percent). The only clinically significant laboratory abnormalities that occurred more frequently in the REMICADE group compared with the placebo group were elevated liver enzymes. Serious AEs occurred at rates of two percent in the placebo group, three percent in the 5 mg/kg group and one percent in the 3 mg/kg group. AEs observed were generally consistent with those described in the prescribing information, including information regarding serious infections. Please see "Important Safety Information" below.-Centocor, Inc.