even another biologic are promising options for plaque psoriasis.6-8 However, the majority of these studies investigated only one class of biologic drugs: tumor necrosis factor (TNF)-alpha antagonists. The newer classes of biologic therapies (targeting IL-12/23, IL-17, and IL-23) may be even more favorable in combination therapy due to their improved safety profiles.8 Additionally, all of these studies were focused on assessing safety and efficacy with very little data on the phenotypes most likely to be prescribed these regimens in the first place.
The Corrona Psoriasis Registry is an independent, prospective observational cohort launched in 2015 with an enrollment target of 12,000 psoriasis patients across the United States (US) and Canada. Corrona registries are designed to study realworld use of biologic therapies and have previously been used to analyze the safety and efficacy of combination therapies in rheumatologic disease.9 While the average length of follow up for Psoriasis Registry subjects is not yet long enough to investigate the safety and efficacy of these regimens, there are sufficient data to conduct an initial analysis of baseline characteristics in this population. These characteristics include demographics, treatment history, disease characteristics and severity, comorbidities, and patient-reported outcomes (PROs). We hypothesize that patients placed on concurrent systemic therapies will differ from the single-agent therapy population in their social, medical, or treatment history. An understanding of which patients are more likely to be prescribed combination systemic therapy will provide important context for long-term efficacy and safety data as they become available.
The Corrona Psoriasis Registry is an independent, prospective observational cohort launched in 2015 with an enrollment target of 12,000 psoriasis patients across the United States (US) and Canada. Corrona registries are designed to study realworld use of biologic therapies and have previously been used to analyze the safety and efficacy of combination therapies in rheumatologic disease.9 While the average length of follow up for Psoriasis Registry subjects is not yet long enough to investigate the safety and efficacy of these regimens, there are sufficient data to conduct an initial analysis of baseline characteristics in this population. These characteristics include demographics, treatment history, disease characteristics and severity, comorbidities, and patient-reported outcomes (PROs). We hypothesize that patients placed on concurrent systemic therapies will differ from the single-agent therapy population in their social, medical, or treatment history. An understanding of which patients are more likely to be prescribed combination systemic therapy will provide important context for long-term efficacy and safety data as they become available.
METHODS
Study Setting
The Corrona PsO registry is a prospective multicenter observational disease-based registry launched in April 2015 in collaboration with the National Psoriasis Foundation (NPF). The registry design and patient enrollment has been previously described.10 Briefly, patients were recruited from 154 private and academic practice sites in the US and Canada with 373 participating dermatologists. As of April 2018, Corrona’s PsO database included information on approximately 2702 patients with 11553 patient visits, and 3892.3 patient-years of follow-up observation time had been collected. The mean time of patient follow-up was 1.36 years (median 1.28 years).
All participating investigators were required to obtain full board approval for conducting research involving human subjects. Sponsor approval and continuing review was obtained through a central IRB (IntegReview Institutional Review Board, Corrona- PSO-500). For academic investigative sites that did not receive a waiver to use the central IRB, full board approval was obtained from the respective governing IRBs and documentation of approval was submitted to the Sponsor prior to initiating any study procedures. All registry subjects were required to provide written informed consent prior to participating.
Study Population
Patients 18 years of age or older who enrolled in the Corrona Psoriasis Registry between April 2015 and March 2017 and initiated an eligible biologic therapy at the time of enrollment were included. Patients were grouped into two mutually exclusive cohorts based on initial treatment regimen: biologic monotherapy and biologic combination therapy. The combination therapy group consisted of patients beginning a new biologic adjunctively with a non-biologic systemic therapy. Biologic therapies included adalimumab, etanercept, infliximab, ixekizumab, secukinumab, and ustekinumab. Non-biologic and small molecule adjunctive therapies included acitretin, apremilast, CsA, and MTX.
Descriptive Characteristics
Demographics, clinical measures, and PROs were examined and compared between biologic mono-therapy and combination therapy groups at treatment initiation. Clinical measures included psoriasis duration and morphology, concomitant PsA, psoriasis area and severity index (PASI), investigator global assessment (IGA), body surface area (BSA) affected, and various comorbidities. PROs included Work Productivity and Activity Impairment (WPAI) scores, self-completed measure of health status (EQ-5D-3L), Dermatology Life Quality Index (DLQI), and overall fatigue, itch, and pain on a visual analogue scale (VAS) 0-100.
Statistical Analysis
Categorical variables were summarized using frequency counts and percentages; continuous variables were summarized by number of observations, mean, standard deviation, median, and the interquartile range (IQR). T-test and Wilcoxon rank sum test were employed for continuous variables and Chi-square of association for categorical variables to test for at least one significant difference across all categories of a variable.
The Corrona PsO registry is a prospective multicenter observational disease-based registry launched in April 2015 in collaboration with the National Psoriasis Foundation (NPF). The registry design and patient enrollment has been previously described.10 Briefly, patients were recruited from 154 private and academic practice sites in the US and Canada with 373 participating dermatologists. As of April 2018, Corrona’s PsO database included information on approximately 2702 patients with 11553 patient visits, and 3892.3 patient-years of follow-up observation time had been collected. The mean time of patient follow-up was 1.36 years (median 1.28 years).
All participating investigators were required to obtain full board approval for conducting research involving human subjects. Sponsor approval and continuing review was obtained through a central IRB (IntegReview Institutional Review Board, Corrona- PSO-500). For academic investigative sites that did not receive a waiver to use the central IRB, full board approval was obtained from the respective governing IRBs and documentation of approval was submitted to the Sponsor prior to initiating any study procedures. All registry subjects were required to provide written informed consent prior to participating.
Study Population
Patients 18 years of age or older who enrolled in the Corrona Psoriasis Registry between April 2015 and March 2017 and initiated an eligible biologic therapy at the time of enrollment were included. Patients were grouped into two mutually exclusive cohorts based on initial treatment regimen: biologic monotherapy and biologic combination therapy. The combination therapy group consisted of patients beginning a new biologic adjunctively with a non-biologic systemic therapy. Biologic therapies included adalimumab, etanercept, infliximab, ixekizumab, secukinumab, and ustekinumab. Non-biologic and small molecule adjunctive therapies included acitretin, apremilast, CsA, and MTX.
Descriptive Characteristics
Demographics, clinical measures, and PROs were examined and compared between biologic mono-therapy and combination therapy groups at treatment initiation. Clinical measures included psoriasis duration and morphology, concomitant PsA, psoriasis area and severity index (PASI), investigator global assessment (IGA), body surface area (BSA) affected, and various comorbidities. PROs included Work Productivity and Activity Impairment (WPAI) scores, self-completed measure of health status (EQ-5D-3L), Dermatology Life Quality Index (DLQI), and overall fatigue, itch, and pain on a visual analogue scale (VAS) 0-100.
Statistical Analysis
Categorical variables were summarized using frequency counts and percentages; continuous variables were summarized by number of observations, mean, standard deviation, median, and the interquartile range (IQR). T-test and Wilcoxon rank sum test were employed for continuous variables and Chi-square of association for categorical variables to test for at least one significant difference across all categories of a variable.
RESULTS
Of the 2702 patients enrolled in the Registry through March 2017, 2189 were on eligible biologic therapies at registry enrollment. Of those, 842 patients initiated treatment at enrollment, with 750 (89%) on systemic mono-therapy and 92 (11%) on systemic combination therapy. Several demographic differences were observed between these two groups (Table 1). Patients on combination therapy were older (mean age 53.0 vs 48.6, P=0.007) and more likely to identify as black (10% vs 4%, P=0.048). The combination therapy group was also more likely to have Medicaid (20% vs 7%, P<0.001) and to report disabled work status (16% vs 7%, P=0.014). A greater percentage of combination therapy patients had Medicare, although the difference was not statistically significant (20% vs 15%, P=0.246).
