Remicade (infliximab) has shown significant efficacy for the treatment of moderate-to-severe psoriasis involving the skin, researchers here reported. The drug is already approved for rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis.
In a multicenter, double-blind trial, 80% of patients randomized to an induction-and-maintenance Remicade regimen achieved a 75% improvement in their baseline psoriasis area and severity index (PASI 75) at 10 weeks.
By comparison, 3% of patients in the placebo arm showed this level of improvement, Kristian Reich, M.D., of Georg-August University here and colleagues reported in the Oct. 15 issue of The Lancet.
Moreover, at 10 weeks 57% of the Remicade-treated patients achieved at least a 90% improvement in PASI (PASI 90) compared with 1% of control patients (P<0.0001 for both).
Remicade demonstrated “high efficacy, rapid onset, and long-term maintenance of therapeutic response for skin as well as nail lesions,” said Dr. Reich and colleagues.
Three hundred and seventy-eight patients were randomized in a 4:1 ratio to Remicade at 5 mg/kg or placebo at weeks 0, two, and six and then every eight weeks to week 46. At week 24, the 77 patients originally assigned to placebo were crossed over to Remicade.
Psoriasis is a common skin inflammation (irritation and swelling) characterized by frequent episodes of redness, itching, and thick, dry, silvery scales on the skin.
Causes, incidence, and risk factors
Psoriasis is a very common condition, with approximately 3 million Americans affected. It can appear suddenly or gradually. In many cases, psoriasis goes away and then flares up again repeatedly over time. The disorder may affect people of any age, but it most commonly begins between ages 15 and 35.
Psoriasis seems to be an inherited disorder, probably related to an inflammatory response in which the immune system accidentally targets the body’s own cells. Evidence of the condition is most commonly seen on the trunk, elbows, knees, scalp, skin folds, or fingernails, but it may affect any or all parts of the skin.
Patients were eligible to enroll in the trial if they had moderate to severe plaque-type psoriasis for at least six months with a PASI score of at least 12, and at least 10% of total body surface area affected.
The primary endpoint was the proportion of patients that achieved at least a 75% improvement in PASI from baseline to week 10.
At week 24, 82% of Remicade patients and 4% of placebo patients maintained PASI 75, and 58% of Remicade patients versus 1% of placebo patients were maintained at PASI 90 (p<0.0001 for both).
The improvements were durable at 50 weeks when 61% of Remicade patients achieved PASI 75 and 45% PASI 90.
In an editorial that accompanied the study, Michael P. Schon, M.D., of the University of Wurzburg in Germany wrote that the major advantage of Remicade and other biologicals is their “low risk for end-organ toxicity and drug-drug interactions.”
But Dr. Schon cautioned that Remicade and other biologicals have not been extensively compared with traditional psoriasis medications.
Moreover, Remicade, which suppresses the immune system by blocking tumor necrosis factor alpha, may increase the risk of opportunistic infections, Dr. Schon concluded.
Revision date: June 20, 2011
Last revised: by Janet A. Staessen, MD, PhD