A lot of tiredness and then a pain that prevents you from carrying out the normal actions of everyday life. This is precisely why living with psoriatic arthritis can be very debilitating and can also lead to depression and isolation. For these patients, however, there is something new that could make their summer more enjoyable by freeing them from the most disabling symptoms. In fact, a new oral therapy belonging to the Janus-kinase class is available and reimbursable in Italy.
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by Dario Rubino
December 31, 2021
What is psoriatic arthritis
More than 300,000 people in Italy have received a diagnosis of this chronic inflammatory disease, which involves the skin, joints and tendons and develops when the immune system attacks healthy tissues and cells. A progressive and debilitating disease, which occurs in 1 out of 3 patients with psoriasis. “Psoriatic arthritis – explains Roberto Caporali, full professor of Rheumatology at the University of Milan, Director of the Department of Rheumatology and Medical Sciences ASST ‘Gaetano Pini’ – CTO of Milan – is a pathology that is part of immune-mediated chronic inflammatory arthritis. The inflammation originates mainly at the level of the enthesis, the point where tendons and ligaments attach themselves to the bone with an involvement, at times, of the synovial membrane which can be inflamed “.
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Manifestations of the disease
Psoriatic arthritis is a heterogeneous disease, which can present in several clinical manifestations, including peripheral arthritis, enthesitis, dactylitis, spondylitis and psoriasis with skin and nail involvement. It is characterized by pain, stiffness, swelling of the joints that can affect the entire body and, if left untreated, can cause permanent damage to the joints and tissues: in 20% of people with psoriatic arthritis, functional disability is observed and, after 10 years, 55% of patients develop deformation in five or more joints. As the disease progresses, the impact psoriatic arthritis can have on patients’ health-related quality of life is believed to be similar to that of diabetes, heart disease and cancer.
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Delays in diagnosis
Unfortunately, this disease is still underdiagnosed today for several reasons. “In the first place – explains Caporali – it is only recently that in some Centers there has been a close collaboration between dermatologist and rheumatologist, which is essential to simplify the early identification of those patients who have early stage arthritis. Secondly, it is often difficult for the patient and the general practitioner to understand which specialist is the reference. In fact, it often happens that patients are sent to specialists other than the rheumatologist ”. Furthermore, rheumatologists themselves should be able to create dedicated paths for these patients with early forms, which should be seen immediately avoiding unnecessary waiting lists that could delay the diagnosis.
Patient needs
Also making life difficult for psoriatic arthritis sufferers is the lack of satisfactory alternatives for patients who are intolerant or unresponsive to DMARDs (disease-modifying antirheumatic drugs) or TNF inhibitors. But today there is a new therapeutic opportunity for patients with psoriatic arthritis: tofacitinib citrate is the first oral Janus kinase inhibitor (JAK) drug approved for this condition. Tofacitinib citrate, developed by the Pfizer company, is available in Italy in combination with methotrexate for the treatment of active psoriatic arthritis in adult patients who have responded inadequately or are intolerant to previous therapy with a disease-modifying antirheumatic drug. (DMARD).
The role of Jak inhibitors
Inhibition of JAKs represents an important resource for the development of new advanced treatment options for autoimmune diseases, as Janus kinases are involved in the signaling of over 50 cytokines, many of which lead to immune-mediated inflammatory conditions. Tofacitinib citrate, already available in Italy for the treatment of rheumatoid arthritis and ulcerative colitis, is the JAK inhibitor with the largest number of approved indications. “This drug – he declares Francesco CicciaProfessor of Rheumatology and Director of the School of Specialization in Rheumatology, University of Campania “Luigi Vanvitelli” – has been used for many years now: it is the first, the forerunner of this class of JAK-inhibitor drugs “.
Oral administration
One of the most appreciated advantages is its oral mode of administration and mechanism of action, which simultaneously blocks multiple cytokines involved in the inflammatory signal. “From a clinical point of view – continues Ciccia – the results in the treatment of psoriatic arthritis are excellent, with an improvement in joint inflammation, a reduction in the number of swollen and painful joints and above all with an impressive effect on the painful component, as it acts by modulating the nociceptive signal in a negative sense, so the patient reports a rapid well-being already after the first weeks of administration, with a really important reduction in the pain share. We have a new weapon at our disposal to treat our patients, many of whom until now remained ‘active’ despite our therapeutic efforts. Tofacitinib is a different drug than those approved up to now and represents an additional opportunity for patients to achieve remission of joint symptoms and a good quality of life “.
He studied his The Lancet
The efficacy, safety and tolerability of tofacitinib in patients with active psoriatic arthritis were demonstrated in the 36-month, extended to 48-month long-term extension clinical trial, OPAL Balance (published in the scientific journal The Lancet in 2021). The study was conducted in 124 centers in 16 countries, with patients participating in the phase III OPAL Broaden and OPAL Beyond studies. Tofacinitib was administered at a dose of 5 milligrams twice daily. The results of the final analysis of the OPAL Balance long-term extension study show that the long-term (up to 4 years) safety profile of tofacitinib in psoriatic arthritis is consistent with that of the phase 3 studies and that the efficacy was maintained for more than 3 years of follow-up among patients remaining in the study, supporting the use of tofacitinib for the long-term treatment of active psoriatic arthritis.