Effectiveness End Points in Real-World Studies on Biological Therapies in Psoriasis: Systematic Review with Focus on Drug Survival

Abstract

Psoriasis is a complex and chronic disease, and, in most cases, therapies are required during all patients’ lifetime. The efficacy and safety profiles of biological therapies are well established, but their effectiveness is still open to discussion. We performed a systematic review to summarize how the effectiveness of biological therapies for psoriasis is measured in real-world studies and to understand whether drug survival, a recent alternative outcome to clinical ones, is a recurrent and valid outcome of effectiveness. In March 2017, we searched for quantitative epidemiological data of psoriasis treatments using PubMed/Medline and EMBASE, and we included 65 publications. The retrospective study design (37%) was most frequent, followed by prospective registries (29%), prospective studies (19%), and retrospective administrative databases/claims. Drug survival was reported in over 60% of prospective registries and retrospective studies, and less frequently in prospective studies. A general consensus emerged in the definition of drug survival as the time patients remain under treatment with a specific therapy, and in its interpretation as an overall marker of treatment success and treatment adherence, as it represents simultaneously information on drug efficacy, drug safety, and patient satisfaction. In conclusion, notwithstanding some limitations, drug survival is a useful measurement of biological therapy effectiveness for psoriasis in daily practice. Its major advantage is that it can be computed also in already collected databases without any specific clinical information on psoriasis. This outcome, combined with evidence on clinical markers of effectiveness, can contribute to better understanding the performance of this expensive class of drugs.

Neutrophils in Psoriasis

“…Furthermore, the combination of certain alternative medicines with conventional drug therapies has been shown to improve the treatment efficacy, which points to the importance of evaluation of safety of combined treatments, education of doctors but also improvements in patient-doctor interactions (40). Indeed, modern biological therapies demonstrate improved safety and efficacy, as well as better satisfaction in patients, but belong to an expensive class of drugs, with limited availability (41). Biological therapies of psoriasis include monoclonal antibodies or inhibitors targeting tumor necrosis factor (TNF)α (infliximab, adalimumab; etanercept) (42–44), interleukin (IL)-23/IL-12 (ustekinumab) (42), IL-23 (guselkumab, tildrakizumab, risankizumab) (45, 46), or IL-17 (secukinumab, ixekizumab, brodalumab) (11, 47, 48).…”

Real-World Evidence From More Than 1000 Patients Treated With Adalimumab For Moderate-to-Severe Psoriasis in the Czech Republic

“…Psoriasis is an immune-mediated, genetic skin disorder associated with both a physical and psychological burden. The disease manifests mainly in the skin and joints but also affects many other organs and tissues and long-term treatment is required [ 1 – 3 ].…”

“…Recently, the term drug survival (or treatment persistence) was defined as the time period when patients remain under treatment with a specific therapy, and it can be used as an overall marker of treatment success and treatment adherence. It simultaneously represents information on drug effectiveness, drug safety, and patient satisfaction [ 3 ].…”

Drug survival in the treatment of generalized pustular psoriasis: A retrospective multicenter study

“…9 "Drug survival," defined as the interval between drug initiation and discontinuation is a relatively new concept for the measurement of therapeutic success in a real-word setting because it incorporates the drug's effectiveness over time, tolerability, quality-of-life, and further patient-oriented and physician-oriented factors. 12,13 Drug survival has been extensively studied in systemic treatment of psoriasis (PsO) [14][15][16][17][18][19][20] and recently of palmoplantar pustulosis. 21 Kishimoto et al investigated drug survival of biologicals in psoriatic patients in Japan.…”