Remicade (infliximab) is a treatment approved by the U.S. Food and Drug Administration (FDA) for ankylosing spondylitis, a type of arthritis that mainly affects the joints of the spine. Doctors also prescribe Remicade, developed and marketed by Janssen, to treat other conditions such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis and plaque psoriasis.
How Remicade works
Inflammatory diseases such as ankylosing spondylitis are characterized by an excessive production of tumor necrosis factor-alpha (TNF-alpha), a cell-signaling protein involved in inflammation, leading to an imbalance in the immune system. Remicade works as a TNF-alpha blocker, which means that it binds to and inhibits the action of TNF-alpha. This inhibition helps reduce pain, stiffness and similar symptoms in patients with ankylosing spondylitis and other inflammatory conditions.
Remicade in clinical trials
It has had FDA approval to treat ankylosing spondylitis since 2004. This approval was based on the results of a randomized, multicenter, double-blind, placebo-controlled Phase 3 trial (NCT00207701) in 279 patients with active ankylosing spondylitis. Patients, ages 18 to 74 were injected with 5 mg/kg of Remicade or placebo into the bloodstream at weeks 0, 2, 6, 12 and 18. They were assessed at week 24 using the ankylosing spondylitis assessment score (ASAS) response criteria and the general health-related quality-of-life questionnaire short-form 36.
Of the patients receiving Remicade, 60 percent showed an improvement in signs and symptoms of ankylosing spondylitis, compared to only 18 percent of those on placebo. Remicade also led to an improvement in the physical component of health-related quality-of-life in patients treated with Remicade. They scored 10.2 on the questionnaire, compared to a score of 0.8 by those on placebo.
Several clinical studies are still investigating its effect on patients with ankylosing spondylitis.
For example, a Phase 3 international multi-center comparative double-blind randomized clinical trial (NCT02762812) aims to assess whether Remicade leads to a decrease in the symptoms of ankylosing spondylitis. To achieve the aim, the researchers will measure the ratio of patients who develop a decrease in ASAS by 20 percent or more after receiving Remicade for 30 weeks. The study is currently ongoing but no longer recruiting participants. It is expected to be completed by mid-2018.
Another study (NCT03074656), known as the Norwegian drug monitoring study (NOR-DRUM), is assessing Remicade’s effectiveness in achieving remission in patients with several immunological inflammatory diseases including ankylosing spondylitis. The study is now recruiting participants in Norway and will likely be completed in March 2022.
A study (NCT03006198) exploring disease characteristics and outcomes of patients with ankylosing spondylitis and other inflammatory diseases treated with Remicade is currently recruiting participants in Algeria, Egypt, Kuwait, Qatar and Saudi Arabia.
In addition, a nationwide biologics registry (NCT01965132) to study the safety profile of Remicade in patients with ankylosing spondylitis is being established in South Korea.
Finally, a study (NCT00085995) now recruiting U.S. participants aims to assess whether computed tomography (CT) scanning is a reliable, valid and sensitive measure of spinal fusion in patients with ankylosing spondylitis. Spinal fusion is the clinical, radiological and pathological hallmark of the disease, which develops slowly in patients with this condition. This study is evaluating the effectiveness of Remicade and other TNF-alpha medications in slowing or stopping the progression of spinal fusion.
Remicade can cause some side effects such as fever, extreme tiredness, flu-like symptoms, skin rashes, cough and stomach pain.
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