Dramatic impact of a Psoriasis Area and Severity Index 90 response on the quality of life in patients with psoriasis: An analysis of Japanese clinical trials of infliximab

Abstract

European S3 Guidelines on the systemic treatment of psoriasis in 2009 propose 75% or more improvement in the Psoriasis Area and Severity Index from baseline (PASI 75) and a Dermatology Life Quality Index (DLQI) of 0 or 1 as treatment goals. However, the relationship of these two parameters is yet to be clarified. Herein, we analyzed the data pooled from two Japanese phase III clinical trials on psoriasis with infliximab to clarify the PASI response necessary to achieve a DLQI of 0 or 1. Of the 90 patients, the mean percent improvement in PASI at week 50 or 66 was 74.5%, and the PASI 75 and PASI 90 response rates were 66.7% and 46.7%, respectively; no difference in the improvement was noted among the body areas. Significant improvements in nail psoriasis were also observed. A negative correlation was shown between the improvement in PASI and DLQI. Patients who achieved a PASI 90 response had a significantly higher percentage of achieving a DLQI of 0 or 1 than the patients who achieved a PASI 75 but not a PASI 90 response. The median serum trough level of infliximab was maintained at 2 lg ⁄ mL or more in the PASI 90 responders, whereas it was less than 1 lg ⁄ mL at week 30 and on in the others. The present results demonstrate that a PASI 90 response is necessary to achieve a DLQI of 0 or 1. Infliximab is considered a useful drug in meeting the treatment goal of achieving a DLQI of 0 or 1 through the attainment of a PASI 90 response.

Serum Infliximab Concentrations in Psoriatic Patients Treated with Infliximab: A Systematic Review

“…A positive relationship between TSI and clinical efficacy (PASI75 or PASI90) assessed at the same time was reported in 4 studies (89 patients) (28,30,32,34). Long-term responders (over 18 months) had detectable TSI (32).…”

“…Eight were original articles (4 randomised clinical trials (3,(26)(27)(28), 3 prospective open studies (29)(30)(31) and one observational study (32)). Two additional articles (33,34) were duplicate publications of selected studies, but were retained in the analysis because they provided additional data on assessment of serum IFX concentrations. Population characteristics, infliximab regimen, methods and times of serum IFX concentration assays are summarised in Table I and Table SI 1 .…”

The Evolution of Quality of Life Assessment and Use in Dermatology

“…Although the complete clearance of skin lesions may be regarded as the ultimate treatment goal for psoriasis, a PASI 75 response has been proposed as a practical and realistic treatment goal [40]. Meanwhile, Torii et al [42] in their study on infliximab considered that a PASI 90 response is necessary to achieve a treatment goal stated in the European S3 guidelines: a DLQI of 0 or 1 (no effect on patient’s QoL). More recently Elewski et al [43] in a study on secukinumab have shown that psoriatic patients with a PASI 90 response achieve greater health-related QoL improvements than those with a PASI 75–89 response and concluded that PASI 90–100 is a relevant therapeutic goal in moderate-to- severe psoriasis.…”

Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis

“…1,2 Advances in understanding the pathogenic cytokine network of psoriasis have led to the development of new treatments [3][4][5] that provide greater efficacy in terms of complete skin clearance. [6][7][8][9] The motivation to completely clear psoriasis plaques from the skin of patients has grown in response to accumulating evidence that residual skin disease can affect a patient's health-related quality of life [10][11][12] similar to that associated with chronic conditions such as type 2 diabetes. 13 Ixekizumab, a recombinant, high-affinity, humanized, IgG4-κ monoclonal antibody, selectively binds and neutralizes interleukin 17A (IL-17A), the proinflammatory and primary effector cytokine of type 17 helper T (Th17) cells.…”