Last Updated on December 31, 2023 by The Health Master
New Delhi: Citing that drug maker, Intas Pharma should report in case of any Serious Adverse Events (SAEs) related to the Phase III clinical trial of Tofacitinib Ointment 2%, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the continuation of the clinical trial of the drug Tofacitinib Ointment 2% as per the approved protocol.
This came after the firm presented the study data of the first 50 patients enrolled in a Phase III clinical trial in accordance with the earlier SEC recommendation dated July 27, 2022.
Tofacitinib is in a class of medications called Janus kinase (JAK) inhibitors. It acts by decreasing the activity of the immune system.
It is used to treat rheumatic conditions, such as rheumatoid arthritis, ankylosing spondylitis, and ulcerative colitis.
Topical Tofacitinib is used for the treatment of vitiligo in adolescent patients.
Since it is a JAK1 and JAK3 inhibitor that interferes with interferon-γ signaling, which reduces CXCL10 chemokine expression, this helps in blocking the activity of vitiligo.
Tofacitinib inhibits Janus kinases, a group of intracellular enzymes involved in signaling pathways that affect hematopoiesis and immune cell function.
Tofacitinib is indicated for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis (RA), active psoriatic arthritis, active ankylosing spondylitis, or moderately-to-severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF( tumor necrosis factor) blockers.
Tofacitinib is not recommended to be used in combination with other biological disease-modifying anti-rheumatic drugs (DMARDs) or potent immunosuppressive agents such as azathioprine or cyclosporine.
The inhibition of JAKs can simultaneously block the function of multiple cytokines.
Therefore, JAK inhibitors are emerging as a new class of drugs, which in dermatology can either be used systemically as oral drugs or locally in topical formulations.
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