2023-07-20 17:26:57
It is available in Italy, and with the approval of the Italian Medicines Agency (Aifa) reimbursed by the National Health Service, tofacitinib for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. The progenitor of a group of ‘small molecules’ for the treatment of immune-mediated inflammatory diseases – explains the pharmaceutical group Pfizer in a note – the drug, administered orally, is an oral Jak inhibitor that has already demonstrated its effectiveness in the treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.
Ankylosing spondylitis – recalls the company in a note – is a disease that is part of the seronegative spondyloarthritis and which mainly affects the lumbar portion of the spine and the sacroiliac joints. According to estimates, it has a prevalence ranging between 0.1 and 1.4% and particularly affects young people, under 45, with a prevalence for men. It initially manifests as pain and chronic low back pain typically lasting more than 3 months, with inflammatory features. If left untreated it can lead to a disabling situation with difficulty walking and carrying out daily activities. Early diagnosis is essential for effective treatment, but nonspecific symptoms can delay diagnosis for up to 11 years after the first signs of the disease appear.
Since this pathology mainly affects young people, the socio-economic impact is significant. A European study found that patients with ankylosing spondylitis have an average annual loss of income of €1,371 and an additional expenditure of €431 on health care and disease-related costs. An analysis conducted to determine the economic impact linked to patient management from the perspective of the NHS and society concluded that adequate therapeutic management of ankylosing spondylitis could significantly reduce costs, especially indirect costs.
“Tofacitinib – explains Roberto Felice Caporali, full professor of Rheumatology and director of the School of Specialization in Rheumatology at the University of Milan, director of the Department of Rheumatology and Medical Sciences Asst ‘Gaetano Pini’ Cto of Milan – is part of a class of drugs that are able to inhibit specific molecules called janus kinases, implicated in an important way in the activation of the inflammatory signal by various pro-inflammatory substances. Simply put, the janus kinases transmit the signal from the outside inside the cell: by modulating their activity they are able to inhibit all the mechanisms that are found downstream, first of all the inflammatory process. This action can prove useful in various chronic diseases characterized by inflammation, such as rheumatoid arthritis and others in the rheumatological and gastroenterological fields. Tofacitinib is administered orally – the specialist remarks – and this represents an advantage for the patient, who does not have to resort to parenteral administration, as happens with many other advanced drugs “.
The pathologies for which tofacitinib is indicated concern different systems and organs, but are united by some mechanisms that support the inflammatory process, Pfizer highlights. “To understand the correlations between arthritis and chronic inflammatory bowel disease – explains Alessandro Armuzzi, full professor of Gastroenterology at Humanitas University and head of the Humanitas Clinical Institute Ibd Center in Rozzano (Milan) – it would be enough to say that at least up to 30% of patients with ulcerative colitis may have associated extraintestinal manifestations such as spondylarthritis, as there is a network of pro-inflammatory molecules that links arthritis to diseases inflammatory bowel disease. The data is explained by the presence of a substrate of genetic predisposition and alterations of the common intestinal microbiota, which predispose a certain percentage of patients with inflammatory bowel disease to develop arthritis. By inhibiting the inflammatory cascade, tofacitinib can act on both pathologies”.
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