Centocor’s Remicade gets ninth FDA OK

Data from a trial named IMPACT 2 served as the primary basis for the approval. In the trial, significant improvements in both American College of Rheumatology and psoriasis area severity index scoring criteria were observed in Remicade-treated patients as early as week two, with further improvements through 24 weeks.

At week 14, 58% of Remicade-treated patients experienced at least 20% improvement in arthritis symptoms, according to the American College of Rheumatology scoring criteria (ACR 20) versus 11% of placebo-treated patients. At week 24, 27% of Remicade-treated patients experienced at least 70% improvement (ACR 70) versus 2% of placebo-treated patients.

Additionally, at week 24, 60% of Remicade-treated patients experienced at least 75% improvement from baseline in psoriasis, as assessed by psoriasis area severity index (PASI 75) versus 1% of placebo-treated patients. At week 24, more than one-third (39%) of patients receiving Remicade achieved PASI 90, a dramatic improvement in psoriasis symptoms. No patients receiving placebo achieved a PASI 90 response at week 24.

Importantly, patients in the Remicade group also experienced decreased symptoms of dactylitis and enthesopathy, two common disease manifestations causing pain and swelling.

In addition to this indication, Remicade has achieved approvals in the treatment of such inflammatory diseases as Crohn’s disease, rheumatoid arthritis, and ankylosing spondylitis.