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Rheumatology Researchers Find Hope in Remicade

First posted Nov. 11, 2002

At the 66th annual American College of Rheumatology conference in late October, international physicians gathered in New Orleans to compare notes, learn about new research and interact with exhibitors.

At the conference, researchers and physicians presented research that offered more support for the use of the biologic drug infliximab (brand name Remicade) to treat psoriatic arthritis and psoriasis. Biologics, a new class of drugs being developed for the treatment of moderate to severe psoriasis and psoriatic arthritis, offer hope for those who do not respond to available psoriasis treatments and psoriatic arthritis treatments. Remicade is currently approved for use in rheumatoid arthritis, a disease that shares some common symptoms with psoriatic arthritis, and Crohn's disease, a serious chronic and progressive inflammation of the colon producing frequent bouts of diarrhea with abdominal pain and nausea and fever and weight loss.

Half of psoriasis patients maintain remission for half a year
On Oct. 27, Alice Gottlieb, M.D., Ph.D., and her team posted findings on the safety and success of Remicade. Significantly, about half of the patients in the study maintained remission for 6.5 months after only three doses of Remicade. The findings were from an open-label extension of a previous study, in order to follow the longer-term success of Remicade.

Twenty-nine patients, some with moderate to severe plaque psoriasis, received Remicade at weeks 0, 2, and 6. During weeks 10 through 26, patients were evaluated to see if the drug still maintained improvement of their symptoms. If the improvement had stopped, they were retreated with Remicade.

According to the findings, Remicade maintained remission for half of the participants, even over the course of 26 weeks. For example, at week 10, 77% of Remicade-treated patients achieved at least 75% improvement from baseline (week 0) in the Psoriasis Area Severity Index (PASI) score, a scale for assessing psoriasis severity and treatment effectiveness. A higher PASI score indicates a more severe level of psoriasis. At week 26, 55% maintained at least 50% improvement and 48% maintained at least 75% improvement in the PASI score. The patients had no serious side events.

Study finds Remicade improves both skin and joint symptoms
On Oct. 28, a team of international researchers presented findings from a phase III trial that Remicade not only treated the joint pain of psoriatic arthritis, but also the psoriatic lesions. Christian Antoni, M.D., from the Department of Medicine, Friedrich-Alexander-University in Erlangen, Germany said that "infliximab was very effective in the treatment of patients with psoriatic arthritis with improvement in both the synovitis and the skin lesions." Synovitis is an inflammation of the synovial membrane that lines a synovial joint, and results in pain and swelling.

Over one hundred patients with active psoriatic arthritis (at least five active joints) participated in a randomized double-blind trial comparing Remicade with placebo (the inactive control substance) over 16 weeks. They then volunteered for the extension trial through week 50.

Patients were given Remicade or placebo at weeks 0, 2, 6 and 14 followed by an open label treatment every 8 weeks. Patients were allowed to stay on some previous medications, such as methotrexate, ibuprofen or steroids.

Researchers studied the patients' disease activity and improvement using the American College of Rheumatology measurements of ACR 20, 50, and 70, which benchmark 20%, 50% and 70% improvements in the signs and symptoms of arthritis. In the Remicade group 70% of 51 patients achieved 20% improvement, while 53% achieved 50% improvement and 26% achieved 70% improvement.

The researchers also studied the patients' skin improvement using the Psoriasis Area and Severity Index (PASI). The average reduction of the PASI in the Remicade group was 80.9%, compared to an average increase of 36% in the placebo group. In addition, nearly 70% of the patients reached an improvement of at least 75%.

Toronto study finds joint improvement isn't sustained
However, not all studies supported the use of Remicade for joint health. Researchers in Toronto found that over the course of a year-long observational study, Remicade didn't sustain the joint improvement for their patients.

Among 16 patients who hadn't responded to at least two disease-modifying agents, Remicade gave moderate relief for joint pain and tenderness. The joint improvement wasn't well sustained over the course of the year, and about half of the patients completed the trial. The others dropped out because of the side effects, including allergic reaction, gastrointestinal bleeding and serious infections.

However, the researchers found that it did provide a marked and well-maintained improvement in psoriasis, and recommended following up their study with a randomized trial.

Developed by Centocor, Remicade was approved for Crohn's disease in 1998 and for rheumatoid arthritis in 1999. Remicade is given by IV infusion in a doctor's office over two to four hours. Remicade specifically targets and binds to TNF-alpha on the cell membrane and in the blood. Overproduction of TNF-alpha is believed to play a role in not only psoriatic arthritis, rheumatoid arthritis and Crohn's disease, but also in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.).