According to a new study in the April issue of The Journal of Rheumatology, rheumatoid arthritis (RA) patients may experience improvement in the pain and stiffness of the disease as early as 48 hours following their first in-office infusion of Remicade® (infliximab) therapy in combination with methotrexate.
“These findings are encouraging because they suggest that patients may improve rapidly in response to Remicade,” said William J. Shergy, MD, principal investigator. “In addition, the possibility of being able to offer a one-hour Remicade infusion to patients who tolerated their initial two-hour treatments may enable rheumatologists to more efficiently manage their time and resources, while also reducing infusion time for some patients to as little as six hours a year.”
Remicade rapidly impacts the inflammatory process underlying RA. Remicade is a monoclonal antibody that specifically targets and irreversibly binds to a key inflammatory mediator called tumor necrosis factor alpha (TNF-alpha), which is believed to play a pivotal role in RA and other inflammatory disorders
The PROMPT (Profiling Remicade Onset with Methotrexate in a Prospective Trial) study was conducted to evaluate the clinical benefits of Remicade two days following initial infusion. The PROMPT study examined the clinical benefit and tolerability of administering Remicade (up to six infusions) in an in-office setting. In addition, the open-label study evaluated the possibility of reducing infusion time from two hours to one hour in a subset of patients for whom the initial four infusions were well tolerated.
A total of 553 patients with active RA despite methotrexate therapy were enrolled at 79 centers across the US. In the open-label study, patients were treated with Remicade (3 mg/kg) given at weeks 0, 2, 6, and 14. Each of the four infusions was delivered over a two-hour period. Follow-up efficacy assessments were conducted at 48 hours and at weeks one, two, six, 14, and 16.
At 48 hours following the first infusion, improvements compared to baseline were observed in duration of morning stiffness (34% average improvement), physician’s global disease assessment score (30%), patient’s global disease assessment scores (25%), and patients pain assessment scores (30%). By week 16, 52 percent to 63 percent average improvements in these four efficacy parameters were recorded.
To evaluate the reduced infusion time of one hour, patients who met pre-specified goals of tolerating the initial four infusions were enrolled into a study extension. These 197 patients received two one-hour infusions of Remicade given eight weeks apart.
The most common of the adverse events associated with the infusion procedure were headache, pruritus and urticaria. Most infusion-related reactions were mild or moderate in nature, and frequency was similar over the two-hour and one-hour infusion time period.
Rheumatoid arthritis affects 2.1 million Americans. It is a chronic, often painful disease characterised by joint inflammation, usually beginning in the hands, wrists, knees, and elbows. The disease affects women more often than men.