Psoriasis (PsO) is a common, chronic inflammatory skin disease.
There is no curative treatment for PsO but there are a number of drugs available for PsO, each one has different characteristics that make one more useful than another in a specific patient population and/or rationale.
Over the past 45 years, there has been an increase in the number of randomized control trials for PsO published in literature.
To understand a drug benefit to risk ratio, a synthesis of the information available, in the form of metanalyses, is useful as it is the highest form of evidence available.
By grouping individual trial patients into larger cohorts according to specific characteristics, the precision of indications is increased.
A Cochrane Network Metanalysis attempted to compare different drugs, which had not been directly compared before . All adult patients with moderate to severe PsO using a systemic treatment were included. Outcomes included safety (serious adverse events) and efficacy (PASI 90). A total of 74 trials were included and more than 40,000 patients. Drugs were ranked according to measured outcomes.
The Cochrane Skin - Core Outcome Set Initiative (CS-COUSIN) is a multi-professional international initiative that supports the development and implements Core Outcome Sets (COS) in dermatology in order to improve and standardise outcome measurement in clinical trials and to make trial evidence more useful (2).
The COS is the minimum set of data for all clinical trials, and these data need to be valid, repeatable and easy to use, whilst being relevant to patients and healthcare professionals.
Patient reported outcome is very important to consider, as there may be a discrepancy between patient and physician satisfaction.
In 25% of the cases in a study of psoriatic arthritis disease, the patient and physician assessment were proven to be misaligned, especially in terms of work and daily activities impairment and disease burden .
With harmonised COS, treatment options for chronic dermatological inflammatory disorders and the assessment of benefits and risks for each drug will be achievable for selected populations and at short-term assessment.
These trials are usually resticted to the selection of “good responders”.
Therefore, other data sources are required with other methodologies with specific outcomes (safety and efficacy) to better understand the real effect of therapies for chronic diseases.
For example, treatment persistence, defined as the time interval between treatment initiation and discontinuation, can measure efficacy and safety, taking into account tolerability and the patient perception of efficacy.
The rates of drug persistence from the French National Health Insurance registered between 2008 and 2016, revealed that >40% of patients stopped their first biological drug within the first year and almost 70% within the first 3 years , highlighting the needs to define the psoriatic strategy for patients.
Precision medicine is a shared clinical decision-making process between the patient and physician , where visual tools assist in the presentation of advantages and disadvantages of different treatments options.
These tools are designed to increase the patients’ knowledge about their disease and consequentially their treatment satisfaction and compliance. See Figure 1.
This is especially important in chronic inflammatory skin disorders without any cure, with several therapeutic options available with limited to moderate efficacy (except for PsO) and burdensome and time-consuming treatment requirements.
We know that a new drug administered to the whole population has a benefit for a subgroup only.
So, we need patient subset information of disease, life-style, and treatment so each, individual patient can benefit from treatment.
Furst DE, Tran M, Sullivan E, et al. Misalignment between physicians and patient satisfaction with psoriatic arthritis disease control. Clin Rheumatol. 2017;36:2045-2054
Sbidian E, Mezzarobba M, Weill A, et al. Persistence of treatment with biologics for patients with psoriasis: a real-world analysis of 16 545 biologic-naïve patients from the French National Health Insurance database (SNIIRAM). Br J Dermatol. 2019;180:86-93.
Kirsten N, Bulai Livideanu C, Richard MA, et al; French Psoriasis Research Group. Inclusion and exclusion criteria in phase III trials with systemic agents in psoriasis: the external validity of drug development. Br J Dermatol. 2016;175:636-8.
Warren RB, Marsden A, Tomenson B, et al.; PSORT Consortium and on behalf of the BADBIR Study Group. Identifying demographic, social and clinical predictors of biologic therapy effectiveness in psoriasis: a multicentre longitudinal cohort study. Br J Dermatol. 2019;180:1069-1076.
Agency for Healthcare Research and Quality (AHRQ). Tools.
With this collection of summaries from selected presentations at SPIN 2019, and interviews with international experts, we hope to share with you some of the highlights of this year’s congress. The international network met … [ Read all ]