With the subcutaneous administration of Infliximab today the patient can count on a more stable drug, with a lower immunogenicity, and with the potential to guarantee efficacy even in the long term.
Scientific research has crossed another milestone: with i bio-better drugs, an evolution of the biosimilar drugs of which the formulation of administration changes, a new and more efficient therapeutic approach is obtained for the Immune-Mediated Inflammatory Diseases (IMIDs). The most significant example of this new solution is represented by Infliximab, a biosimilar drug produced by the South Korean Celltrion Healthcare, whose subcutaneous use has been approved by AIFA per Rheumatoid arthritis in February and for Diseases Inflammatory Chronic Intestinal (Crohn’s Disease and Ulcerative Colitis) last June. A step destined to generate improvements from a clinical, logistic and economic point of view. The new perspectives and the most recent studies on the subject were exposed in the conference “REm STARt – a new journey in the treatment of IMIDs”, In which the various specialists intervened, given the multidisciplinary approach necessary for the treatment of these diseases.
Inflammatory diseases, bio-better drugs: the scenario
the IMIDs comprise a group of chronic diseases characterized by an inappropriate or excessive immune response, which in turn results in an over-expression and over-activation of pro-inflammatory cytokines, including TNF-alfa plays a key pathogenetic role. Control of this immune system reaction by treatment with Infliximab, monoclonal antibody inhibitor of TNF-alfa, has made it possible to obtain satisfactory results in patients suffering from severe forms of the disease. Infliximab has been in use since the late 1990s, but was administered intravenously for twenty years.
“These pathologies are many and involve different specialties, from rheumatology to gastroenterology, passing through dermatology, ophthalmology and others – explains Prof. Roberto Caporali, Full Professor of Rheumatology, University of Milan | Director of the Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, MI – In daily clinical practice we have two problems: first of all, these diseases are difficult to diagnose, and only an early diagnosis can allow an easy management of the disease. Secondly, we need effective drugs: with antibodies to TNF-alpha at the end of the 90’s it was possible to control the disease, favor its remission and therefore allow the improvement of the quality of life. With subcutaneous administration, maintaining the same mechanism of action, we can guarantee further benefits “.
Inflammatory diseases: with Infliximab there is the transition from biosimilar and bio-better drugs
With the new possibility of administering Infliximab even subcutaneously, new opportunities open up with enormous improvements. “In recent months, a new era has opened in the world of Immune-Mediated Inflammatory Diseases and specifically of IBD – underlines Prof. Alessandro Armuzzi, Associate Professor of Gastroenterology, A. Gemelli University Polyclinic Foundation IRCCS – Catholic University of the Sacred Heart, Rome – The novelty of having the subcutaneous administration of Infliximab available with the same formulation as the intravenous one allows us to be able to count on a known drug, which works very well, offers greater stability in the presence of the serum drug concentration in the patient (trough level) and causes a lower immunogenicity, the latter factor determining the loss of response to the drug itself “.
“The launch of subcutaneous infliximab represents a strong innovation – comments Prof. Silvio Danese, Director of Gastroenterology and Full Professor of Gastroenterology at San Raffaele Milan – It is a drug defined as bio-better: the effectiveness we know thanks to twenty years of experience is accompanied by the new formulation that brings benefits in terms of trough level, ie blood concentration, but above all there is a convenience for the patient, given that the treatment moves from the hospital to the home “.
Inflammatory diseases, the advantages of bio-better and subcutaneous administration
“The administration of Infliximab under the skin, allowing the patient not to be forced to periodically go to the hospital, allows a reduction in indirect costs, with fewer days of work lost, less commitment to treatment, lower social cost of the disease. In addition to the benefit for the patient, this also means that clinicians can free up resources within their hospitals – he highlights Ambrogio Orlando, Director of the UOSD Chronic Inflammatory Intestinal Diseases, Ospedali Riuniti Villa Sofia Cervello Hospital, Palermo – These elements are fundamental and must be included in the overall assessments on the cost of drugs: not only the direct cost must be considered, but also the final outcome of the treatment, also taking into account the effectiveness of the response, the quality of life of patients and the use of resources by health facilities. In the next 10 years we could have great benefits in the management of these diseases ”.
Inflammatory diseases, bio-beta drugs: the rheumatological point of view
In rheumatology, Infliximab is used for inflammatory joint diseases such as rheumatoid arthritis, psoriasis arthritis, spondyloarthritis. At present, subcutaneous use is only approved for Rheumatoid arthritis. “It is a precious drug, which allows you to control the symptoms of the disease well – underlines Prof. Fabrizio Conti, Full Professor of Rheumatology, University of Rome “La Sapienza” | UOC Director of Rheumatology, AOU Policlinico Umberto I, Rome – Like other biological drugs, it determines the blocking of an inflammation protein, in this case TNF: doing so helps the patient to avoid a progression of the disease towards joint damage and to recover a better quality of life. The results of a recent study have shown that there are no differences in the clinical response between the intravenous and subcutaneous formulations, so we will be able to benefit from the advantages of the latter “.
“The differences do not concern only the method of administration, which is already an advantage, but there is also an improvement in the response, because the formulation is not a simple conversion of the method of administration, but also allows an improvement in efficacy in pharmacological terms. – highlights Prof. Florenzo Iannone, Full Professor of Rheumatology, University of Aldo Moro, Bari | UOC Director of Rheumatology, University Hospital Consortium – Policlinico, Bari – Rheumatoid arthritis in Italy has a prevalence between 0.5% and 1%, therefore it has about 600 thousand patients in adulthood. Equally relevant is the group of spondyloarthritis, which includes ankylosing spondylitis but alsopsoriasis arthritis, where infliximab is widely used and has high levels of efficacy. We therefore await approval for these other pathologies and for subcutaneous use right from the beginning of the therapy “.