Redefining the therapeutic objective in psoriatic patients candidates for biological therapy

Abstract

The advances in psoriasis management currently allow achieving a good control of the disease. In particular, with the latest developed molecules, available evidence suggests that it is possible to pose an ambitious therapeutic goal, such as a Dermatology Life Quality Index 0/1, a Physician Global Assessment 0/1, or a Psoriasis Area and Severity Index 90/100 response. However, patients often fail to achieve the complete clearance of their cutaneous lesions or the improvement of disease factors that impair their quality of life. To optimize the treatment of psoriasis, it is not enough to define precisely the therapeutic objective, but also to adapt the therapeutic strategy to make the necessary modifications in case of not achieving it at the time point (at the end of the induction phase, or every 3-6 months) to be agreed with the patient (the so-called treat-to-target approach). In the present report, based on the Delphi methodology, 11 dermatologists from the Spanish Psoriasis Group addressed key issues that could be involved in the achievement and maintenance of the therapeutic goals of patients with moderate to severe psoriasis. The document provides 27 consensus statements intended to support clinical decision-making by healthcare professionals for patients who might be candidates to receive biologic therapy.

Psoriasis treat to target: defining outcomes in psoriasis using data from a real‐world, population‐based cohort study (the British Association of Dermatologists Biologics and Immunomodulators Register, BADBIR )

“…Our study serves as the first validation of growing expert opinion supporting the use of absolute rather than relative measures of disease severity as treatment end points in psoriasis . A recent consensus opinion paper based on the Delphi methodology proposed that absolute PASI ≤ 2 should be the pursued PASI goal, as it was felt to correlate better than relative PASI with the health‐related quality‐of‐life measure DLQI . Our data support current trends in trial practices, whereby the proportions of patients achieving absolute PASI values are increasingly reported as secondary end points due to the recognition that these values may be more clinically meaningful than relative PASI measures …”

Absolute and Relative Psoriasis Area and Severity Indices (PASI) for Comparison of the Efficacy of Ixekizumab to Etanercept and Placebo in Patients with Moderate-to-severe Plaque Psoriasis: An Integrated Analysis of UNCOVER-2 and UNCOVER-3 Outcomes

“…The ultimate treatment goal for psoriasis is clear or almost clear skin, with many clinicians now advocating robust treatment goals of ≥ 90% improvement over www.medicaljournals.se/acta base line PASI, given the increased efficacy of the newer treatments (2,6). With respect to PASI 90, the current absolute PASI band analyses showed that both PASI > 0 to ≤ 1 and > 1 to ≤ 2 responder populations exhibited good overlap with the responder populations for PASI 90, as well as for sPGA (0,1).…”

“…Itching, stinging, and pain are common symptoms. Psoriasis can be associated with several comorbidities, such as metabolic syndrome and cardiovascular disease, which add to its physical and psychological burden, negatively affecting the patient's health-related quality of life (HRQoL) (1)(2)(3).…”

“…In clinical studies, a reduction from baseline in absolute PASI score of ≥75% (PASI 75) or ≥ 90% (PASI 90) is recommended as a primary endpoint to assess the treatment efficacy by the European Medicines Agency (5). Moreover, PASI 75 and PASI 90 responses have been found to be positively associated with patients' HRQoL assessments, indicative of clinically meaningful improvements in the disease activity (2,6). However, the use of relative PASI measures has some limitations.…”

“…Notably, calculation of the relative PASI requires knowledge of the baseline disease status, which may not be known in routine clinical practice or other clinical settings where patients may switch from other treatments without a washout period (7). Further, patients, particularly those with moderate-to-severe disease, may reach PASI 75 or PASI 90 relative to their initial disease status but still have significant disease activity and HRQoL problems (2,6). As the absolute PASI has the advantage of being indicative of the individual patient's severity of disease at the time of analysis, independent of baseline PASI score, use of alternative treatment targets based on the absolute PASI scores have been proposed for assessment the ef-fectiveness of new treatments (6).…”