The introduction of biologics into the field of dermatology was considered by the European regulatory authorities to require a level of guidance with respect to appropriate usage, with a particular focus on balancing clinical benefits against potential risks. Part of the background for this comes from the previous experience of the EMEA with biologics in rheumatology and inflammatory bowel disease. These newer drugs have proven to be very effective and potent medicines, although a better understanding of how best to use them to maximize the therapeutic benefits to the patient, while at the same time avoiding adverse effects, requires a mechanism through which real-life clinical experiences can be shared. Increasing the available patient data and communicating this to the global medical community not only improves awareness, it facilitates broader interrogation and interpretation of clinical findings with the goal of improving outcomes and moving toward best practices. There are a number of tools available to the physician during the prelaunch and early postlaunch period, such as product positioning (the responsibility of all of the research community), product information/labeling and monitoring of registry studies. None of these provide a complete picture, but they all add to the information base that enables clinicians to make more-informed decisions.
For products such as infliximab (Remicade®), the size of the patient database has increased significantly during the launch process and this includes a wide range of clinical experience across different diseases (e.g., rheumatoid arthritis, Crohn’s disease and psoriasis), including a certain amount of off-label usage. In countries such as the UK, there is a mandated pharmacovigilance program for the reporting of adverse effects and this provides another level of information that can be included in risk–benefit assessments. In such a dynamic information environment, the Committee for Medicinal Products for Human Use provides guidelines for risk–management systems (Box 1). An important aspect of these guidelines is the process of ‘learning, responding and adjusting’ to improve medical practice, and achieving this communication is a crucial element.
The above represents the background to the development of the Remicade Academy in Dermatology (READY) program, which was developed by Schering-Plough, in collaboration with key opinion leaders, advisory boards and steering groups, to obtain a better understanding of the risk–benefit equation for infliximab so as to optimize its use in patients with psoriasis (Box 2).
The READY program consisted of three stages:
• Meet the expert: this involved taking advice from key opinion leaders in the field of psoriasis;
• Clinical observation program: this involved translating the feedback from the key opinion leaders into best-practice advice for dermatologists with a feedback mechanism to facilitate ‘learning, responding and adjusting’;
• Scholars Club: this was an offsite meeting with leading clinicians that was designed to investigate/assess specific issues related to experience with infliximab thus far. Built around a program of plenary lectures and workshops, the intent was to bring together expert opinion and personal experiences so as to help direct best practices in this challenging therapeutic arena.
Box 1. Committee for Medicinal Products for Human Use guidelines on risk management.
• The management of a single risk consists of four steps: risk detection, risk assessment, risk minimization and risk communication
• A risk management system is defined … as a set of pharmacologic activities and interventions designed to proactively identify, characterize and prevent or minimize risks relating to medicinal products, including risk communication and the assessment of effectiveness of risk minimization interventions
Box 2. What is the READY program?
• READY is the process that Schering-Plough has developed to teach hospital-based dermatologists to become comfortable and confident users of Remicade® in the treatment of moderate-to-severe psoriasis
• READY prepares physicians to use Remicade in the treatment of psoriasis and covers:
– Efficacy
– Safety
– Patient selection
– Outcomes and quality-of-life expectations
– Practical issues of running an infusion clinic
– Reimbursement issues
Summary
• The Remicade Academy in Dermatology (READY) program was initiated in full consultation with the EMEA based on their requirements for a risk–management program.
• An Advisory Board involving leading dermatologists was assembled to provide advice and direction.
• The program was initiated as a pilot by a steering group and involved communication and training with the experts, including key stakeholders in many countries.
• The implementation stage, which involved widening the coverage of the communication and training programs, included nurses, who play an important role in intravenous drug delivery to patients.
• Finally, The Scholars’ Club currently brings together all the knowledge that we have gained to date, which can be shared and discussed to promote best practice usage for infliximab to help improve the lives of patients with psoriasis, a debilitating disease that negatively impacts the individual’s quality of life.
Financial & competing interests disclosure
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing assistance was provided by Steve Clissold, PhD (Content Ed Net), with funding by Schering-Plough, USA.
Notes
Committee for Medicinal Products for Human Use guidelines for risk management as applied to the READY program for infliximab.
Details of the READY program for infliximab.