Immune-mediated inflammatory diseases (IMID) include many chronic inflammatory conditions having a common pathogenic feature: immune dysregulation. This leads to organ impairs in different clinical settings, such as rheumatologic (ankylosing spondylitis, rheumatoid arthritis, lupus) dermatologic (psoriasis, psoriatic arthritis), gastroenterological (inflammatory bowel disease) neuromuscular and vascular.
The prevalence of IMID in Western society is about 5%–7%. Although some IMID, such as psoriasis, have similar prevalence among men and women, others, including rheumatoid arthritis, are much more prevalent among women. The utilization of biologics for the treatment of IMID increased in clinical practice and many biosimilars are marketed in the meantime. In pharmacoepidemiology, the use of real-world data involves several advantages, such as allowing studies with large sample of individuals, representing the entire population of drug users, extended follow-up periods and long-term effect evaluations, and the assessment of the related economic impact.
These can be particularly useful for investigations of chronic diseases.
Evidence-based comparisons of long-term safety and effectiveness among biologics and costs in IMIDs are needed, to assist physicians in clinical decision-making and policymakers. The scenario is further complicated by heterogeneous results of studies evaluating adherence. This ranges from 11% to 89% for biologics. In addition, clinical questions arising from the usage of biosimilars and aiming at getting answers on their patterns of utilization, safety, costs and effectiveness, lead to the need of improving education for patients and obtaining evidence-based solutions for healthcare professionals and assisting policymakers.
The real-world data on the usage of biologics and biosimilars among patients with IMIDs will allow supporting regulatory affairs and users at all levels by making them more confident with these drugs in clinical practice.
We will accept all types of manuscripts on real-world studies investigating the following research topics:
- data source validation (e.g. exposure, outcomes, disease-related variables) - drug utilization (e.g. persistence, adherence, switching, discontinuation) - effectiveness (e.g. visits, disease-related endpoints) - safety (e.g. hospitalizations, emergency department admissions, adverse drug events) - regulation - pharmacoeconomic analyses of biologics/biosimilars in IMIDs.
Real-world studies on drug classes or single biologic/biosimilar, descriptive and/or making comparisons between a biologic/biosimilar and another, between originators and biosimilars, and between biologics and conventionals will be accepted.
Dr. Ylenia Ingrasciotta is the CEO of the academic spin-off “INSPIRE srl” of the University of Messina, which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.) and from pharmaceutical Companies (Chiesi Italia, Kyowa Kirin s.r.l., Daiichi Sankyo Italia S.p.A.).
Immune-mediated inflammatory diseases (IMID) include many chronic inflammatory conditions having a common pathogenic feature: immune dysregulation. This leads to organ impairs in different clinical settings, such as rheumatologic (ankylosing spondylitis, rheumatoid arthritis, lupus) dermatologic (psoriasis, psoriatic arthritis), gastroenterological (inflammatory bowel disease) neuromuscular and vascular.
The prevalence of IMID in Western society is about 5%–7%. Although some IMID, such as psoriasis, have similar prevalence among men and women, others, including rheumatoid arthritis, are much more prevalent among women. The utilization of biologics for the treatment of IMID increased in clinical practice and many biosimilars are marketed in the meantime. In pharmacoepidemiology, the use of real-world data involves several advantages, such as allowing studies with large sample of individuals, representing the entire population of drug users, extended follow-up periods and long-term effect evaluations, and the assessment of the related economic impact.
These can be particularly useful for investigations of chronic diseases.
Evidence-based comparisons of long-term safety and effectiveness among biologics and costs in IMIDs are needed, to assist physicians in clinical decision-making and policymakers. The scenario is further complicated by heterogeneous results of studies evaluating adherence. This ranges from 11% to 89% for biologics. In addition, clinical questions arising from the usage of biosimilars and aiming at getting answers on their patterns of utilization, safety, costs and effectiveness, lead to the need of improving education for patients and obtaining evidence-based solutions for healthcare professionals and assisting policymakers.
The real-world data on the usage of biologics and biosimilars among patients with IMIDs will allow supporting regulatory affairs and users at all levels by making them more confident with these drugs in clinical practice.
We will accept all types of manuscripts on real-world studies investigating the following research topics:
- data source validation (e.g. exposure, outcomes, disease-related variables) - drug utilization (e.g. persistence, adherence, switching, discontinuation) - effectiveness (e.g. visits, disease-related endpoints) - safety (e.g. hospitalizations, emergency department admissions, adverse drug events) - regulation - pharmacoeconomic analyses of biologics/biosimilars in IMIDs.
Real-world studies on drug classes or single biologic/biosimilar, descriptive and/or making comparisons between a biologic/biosimilar and another, between originators and biosimilars, and between biologics and conventionals will be accepted.
Dr. Ylenia Ingrasciotta is the CEO of the academic spin-off “INSPIRE srl” of the University of Messina, which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.) and from pharmaceutical Companies (Chiesi Italia, Kyowa Kirin s.r.l., Daiichi Sankyo Italia S.p.A.).