As the use of immunotherapies and biologics expand across dermatology indications, make sure you know the specific considerations for your clinical trial
As the science underpinning dermatological conditions has become more thoroughly understood, new therapeutic pathways have been identified and treatment options have rapidly evolved into biologic therapeutics and beyond. The first biologic approved for a dermatological indication was Amevive® for psoriasis in 2003. Today, there are more than 10 drugs on the market to treat psoriasis alone.1 Some biologics, such as dupilumab, have also been trialed for conditions outside of dermatology, such as asthma,2 eosinophilic esophagitis,3 and nasal polyposis.4
Many inflammatory conditions result from intracellular translation and transcription pathways. Agents that can affect these pathways are now in active research. Treatments that target the regulation of the JAK/STAT pathway have been approved by the FDA to treat rheumatoid arthritis, psoriatic arthritis and ulcerative colitis,5 and they are now being heavily explored in many inflammatory diseases of the skin. Another notable pathway involves S1P blockade, effectively sequestering activated lymphocytes and reducing inflammation. Evidence now suggests that S1P modulation may be an effective approach in many inflammatory conditions, including atopic dermatitis.6
The global commercial dermatology market will continue to thrive, and is estimated to reach $33.7 billion by 2022, rising at a 7.73 percent compound annual growth rate from 2015 to 2022.7 With this momentum and the continued need for safe and effective dermatology treatments, it’s important to understand the strategic needs of clinical trials using novel immuno-dermatology agents.
Considerations for immuno-dermatology clinical trials
1. Patient inclusion and exclusion criteria
Since their development in dermatology indications, biologics have usually been reserved for those presenting with moderate-to-severe presentations of disease. Typically, this means patients must have exhausted front-line treatments, like topicals or phototherapy, to be offered a biologic. Clinical trials that involve treatments with similar mechanisms of action require similar patient profiles, and it is therefore critical to tailor eligibility criteria for successful patient recruitment.
2. Site selection and enrollment
Patient enrollment in dermatology studies can be a challenge. Clinical trial sites tend to be limited in numbers and will therefore quickly exhaust their local patient pool. Analytics are key drivers identifying and integrating diverse sites. At IQVIA Biotech, we use data-driven analytics, site relationships, and extensive expertise in dermatology trials to identify sites and patients to drive recruitment and enrollment.
New agents with novel mechanisms of action may require niche safety monitoring. Integrating different therapeutic areas into trial safety, such as respiratory, ophthalmology and cardiology, is becoming more relevant in dermatology trials. It’s important to carefully review all procedures with a critical needs assessment to identify those that support study endpoints. Eliminating extraneous procedures and excessive visits can improve patient recruitment and retention.
3. Safety management
Biologics have a relatively favorable safety profile compared to other modes of therapeutics. However, biologics are not without side effects. Therefore, safety management in clinical trials must be a strong consideration, especially in Phase II or Phase III trials where pharmacokinetic draws and close oversight are required. Furthermore, additional safety monitoring may be required that is not typical for a dermatology trial, such as more involvement from the medical monitor on the study and the use of a data safety and monitoring board.
4. Clinical endpoints
Traditional endpoints in dermatology include Psoriasis Area and Severity Index (PASI), or Eczema Area and Severity Index (EASI), and while these assessments have their place in dermatological research, they are not always optimal assessments. At IQVIA Biotech, we continue to monitor and provide guidance on the most current assessment tools that regulatory agencies accept in clinical trials around the world. For example, the FDA encourages the use of a Physicians Global Assessment as a primary endpoint, rather than the typical EASI or PASI. Determining the optimal endpoints for your dermatology study can be critical in gaining approval of your immunotherapy.
Moving forward with your immuno-dermatology study
Biologics are proving to positively impact patients in both skin clearance and quality of life. Although further research is needed, and there are specific considerations when running immuno-dermatology clinical trials, these can be overcome with expert guidance and support.
Contact us today to learn how IQVIA Biotech can support you with your immuno-dermatology study.
References:
1. National Psoriasis Foundation. “Biologics” Accessed April 16, 2021. https://www.psoriasis.org/biologics/
2. Rathinam K., et al. “Dupilumab in the Treatment of Moderate to Severe Asthma: An Evidence-Based Review. Current Therapeutic Research. 2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6911908/
3. Hirano I., et al. “Efficacy of Dupilumab in a Phase 2 Randomized Trial of Adults With Active Eosinophilic Esophagitis.” Gastroenterology. Oct. 2019. https://www.gastrojournal.org/article/S0016-5085(19)41415-7/fulltext?referrer=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov%2F
4. Bachert C., et al. “Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial.” JAMA. Feb. 2016. https://jamanetwork.com/journals/jama/fullarticle/2484681
5. Ballard, A. “JAK inhibitors are coming and they are the biggest eczema development in years” Jan. 14, 2021. https://nationaleczema.org/jak-inhibitors-research/
6. Thieme, M., Zillikens, D., Sadik, C. “Sphingosine-1-phosphate modulators in inflammatory skin diseases – lining up for clinical translation” Experimental Dermatology. Aug. 30, 2016. https://onlinelibrary.wiley.com/doi/full/10.1111/exd.13174
7. Market Research Reports press release. “Global Dermatology Market: Increasing Proliferation Of Lucrative Late-Stage Products To Drive Growth.” Aug. 23, 2016. https://www.globenewswire.com/news-release/2016/08/23/866142/0/en/Global-Dermatology-Market-Increasing-Proliferation-Of-Lucrative-Late-Stage-Products-To-Drive-Growth-MarketResearchReports-biz.html