Many new highly effective drugs provide new opportunities for patients with atopic dermatitis and psoriasis. Impressive clinical trial programs inform us on safety and efficacy by short-term studies with primary endpoints after 16 weeks and long-term studies of at least 1 year. The populations of patients in the trials are defined by the inclusion and exclusion criteria. Active comparators are chosen, although comparative studies between drugs within one class are very rare.
In daily practice many questions cannot be answered by studies from clinical trial programs. The population in real world is much broader than studied in the clinical trial programs. First of all, cut off point for clinical severity have been defined which are artificial. In many countries a Psoriasis Area and Severity Index (PASI) >10 or Body Surface Area (BSA)>10 set the obligatory minimal severity before a biologic will be reimbursed in the treatment of psoriasis by the insurance companies in many countries. In the International Psoriasis Council (IPC) a recategorization of disease severity has been proposed and several national guidelines refer to this new classification (Citation1). The IPC definition is much more a practice driven definition instead of a data driven definition. Patients who either fail to topical treatment, have psoriasis at difficult sites (flexures, scalp, genitalia, palm and soles, nail) are regarded as severe and are eligible for systemic treatments. Patients with PASI < 10 or BSA < 10% with psoriasis at difficult sites may have a severely impaired quality of life, justifying a systemic treatment. However, in this compartment of disease severity we have no clinical trial data.
In daily practice we have special groups of patients which are not represented in clinical trials: elderly patients which have more comorbidities, children with psoriasis or atopic dermatitis, patients with comorbidities which are not regarded as contra-indication and patients with a busy life, who cannot afford the time to participate in clinical trials.
Patients with psoriasis and atopic dermatitis with its many phenotypes and comorbidities, with risk factors for comorbidities and patients with their individual circumstances and health issues require a personalized selection of treatments. The information from clinical trials is limited. What information is needed to help management of chronic inflammatory skin diseases in real life?
As dermatologists we have to integrate a lot of medical data and lifestyle data and make individual decision, based on a variety of factors. Although evidence on these reallife issues are limited we have to make best use of available evidence and use our intuition, based on years of experience.
In order to make use of the new treatment opportunities to the best of the individual patient with his/her expression of psoriasis we have to invest in a learning health care environment. Collect the reasons for our treatment-decisions in patient registries, collect biomarkes, connect between registries and analyze which factors have relevance for individualized treatment selection (Citation2).
Disclosure statement
No potential conflict of interest was reported by the author(s).
References
- Strober B, Ryan C, van de Krkhof PCM, et al. Recategorization of psoriasis severity: Delphi consensus from the international psoriasis council. J Am Acad Dermatol. 2020;82(1):117–122.
- Parad JE, Liao W. Bioinformatic applications in psoriasis: genetics, transcriptomics, and microbiomics. Semin Cutan Med Surg. 2019;38(1):E3–E11.