Several other issues further complicate the selection and use of biologics. For example, it is possible for a given biologic to lose efficacy over time in a patient who initially responds favorably.9 Further, there is a small percentage of patients who fail to recapture their initial level of response when their biologic therapy is resumed after a period of discontinuation, and switching biologics entirely may not always result in improved efficacy.9 More evidence is needed to determine the relative efficacy of biologics in patients with psoriasis who have previously received biologic therapy (“bio-experienced”) vs those who are initiating biologic therapy for the first time (“bionaïve”), particularly in a real-world setting.
Another consideration in the use of biologics relates to body weight. Patients with psoriasis, particularly those requiring systemic treatment, tend to be above normal weight, and it is now recognized that obesity is a risk factor for the incidence and severity of psoriasis.17-20 Excess body weight may interfere with therapeutic efficacy, with high interference identified for fixed-dose biologics that do not account for differences in body weight.17,18,20 In fact, body weight reduction in obese patients on biologics may increase the efficacy of the drug, especially for agents that are administered at fixed doses.19-21 Studying clinical outcomes in patients who vary in body weight in a realworld setting will help guide treatment approaches.
In the present study, we performed a retrospective chart review to address some of these issues and determine if they contribute to biologic efficacy in daily dermatology practice. Clinical outcomes involving 9 different biologic agents were assessed up to 1 year after the biologics were prescribed to bio-naïve or bio-experienced patients who had a wide range of body weights.
Another consideration in the use of biologics relates to body weight. Patients with psoriasis, particularly those requiring systemic treatment, tend to be above normal weight, and it is now recognized that obesity is a risk factor for the incidence and severity of psoriasis.17-20 Excess body weight may interfere with therapeutic efficacy, with high interference identified for fixed-dose biologics that do not account for differences in body weight.17,18,20 In fact, body weight reduction in obese patients on biologics may increase the efficacy of the drug, especially for agents that are administered at fixed doses.19-21 Studying clinical outcomes in patients who vary in body weight in a realworld setting will help guide treatment approaches.
In the present study, we performed a retrospective chart review to address some of these issues and determine if they contribute to biologic efficacy in daily dermatology practice. Clinical outcomes involving 9 different biologic agents were assessed up to 1 year after the biologics were prescribed to bio-naïve or bio-experienced patients who had a wide range of body weights.
MATERIALS AND METHODS
Study Design
This was a single-center, observational study of 100 patients to assess the efficacy of biologic therapy in a real-world setting in a psoriasis population consisting mostly of patients with moderate-to-severe psoriasis, per baseline BSA assessments. A retrospective chart review was conducted for patients who were evaluated at the center between August 1, 2015, and November 1, 2019.
Patients who had initiated biologic therapy within 6 months of the baseline visit and who had a follow-up visit within a 12-month period were selected for analysis. Eligible patients included male and nonpregnant female adults ≥18 years of age with moderate-to-severe chronic plaque psoriasis. Patients who were undergoing therapy with a conventional systemic treatment for psoriasis discontinued their regimen at the time of biologic prescription; systemic treatments could be added later at the discretion of the study investigator. Concomitant use of topical medications was permitted throughout the study duration. Treatment was guided by each patient’s clinical response and insurance coverage, with biologic prescriptions being switched, titrated, or discontinued as needed. Modifications to a patient’s biologic regimen was allowed at the follow-up visit, or any time prior. Additional psoriatic treatments, including traditional systemic therapies, were prescribed in combination with biologic therapy as needed.
This study was conducted in accordance with the principles of the Declaration of Helsinki and with Good Clinical Practice guidelines.
Study Outcomes
Efficacy and safety assessments were performed at baseline and follow-up visits. Disease severity outcome measures included the percent of affected BSA, score on the 5-point PGA in which 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe, and the BSA×PGA composite score. Additional efficacy assessments included the overall disease improvement at follow-up, which was calculated as (BSA×PGAfollow-up – BSA×PGAbaseline)/ BSA×PGAbaseline, and the percent of patients achieving the National Psoriasis Foundation (NPF) Treat to Target (TTT) goal of BSA ≤1% at follow-up.13 Adverse events (AEs) were captured as observations from the investigator or events reported by the patients, regardless of severity, seriousness, or causality.
Statistical Analysis
All analyses were performed by the investigator. No comparator statistical testing was performed for the efficacy or safety data. Continuous variables were summarized using descriptive statistics. For categorical variables, frequencies and percentages were presented. Data were summarized for the overall population and for subgroups of patients that were stratified by baseline body weight, prior experience with biologics, and the class of biologic that was initiated at baseline.
This was a single-center, observational study of 100 patients to assess the efficacy of biologic therapy in a real-world setting in a psoriasis population consisting mostly of patients with moderate-to-severe psoriasis, per baseline BSA assessments. A retrospective chart review was conducted for patients who were evaluated at the center between August 1, 2015, and November 1, 2019.
Patients who had initiated biologic therapy within 6 months of the baseline visit and who had a follow-up visit within a 12-month period were selected for analysis. Eligible patients included male and nonpregnant female adults ≥18 years of age with moderate-to-severe chronic plaque psoriasis. Patients who were undergoing therapy with a conventional systemic treatment for psoriasis discontinued their regimen at the time of biologic prescription; systemic treatments could be added later at the discretion of the study investigator. Concomitant use of topical medications was permitted throughout the study duration. Treatment was guided by each patient’s clinical response and insurance coverage, with biologic prescriptions being switched, titrated, or discontinued as needed. Modifications to a patient’s biologic regimen was allowed at the follow-up visit, or any time prior. Additional psoriatic treatments, including traditional systemic therapies, were prescribed in combination with biologic therapy as needed.
This study was conducted in accordance with the principles of the Declaration of Helsinki and with Good Clinical Practice guidelines.
Study Outcomes
Efficacy and safety assessments were performed at baseline and follow-up visits. Disease severity outcome measures included the percent of affected BSA, score on the 5-point PGA in which 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe, and the BSA×PGA composite score. Additional efficacy assessments included the overall disease improvement at follow-up, which was calculated as (BSA×PGAfollow-up – BSA×PGAbaseline)/ BSA×PGAbaseline, and the percent of patients achieving the National Psoriasis Foundation (NPF) Treat to Target (TTT) goal of BSA ≤1% at follow-up.13 Adverse events (AEs) were captured as observations from the investigator or events reported by the patients, regardless of severity, seriousness, or causality.
Statistical Analysis
All analyses were performed by the investigator. No comparator statistical testing was performed for the efficacy or safety data. Continuous variables were summarized using descriptive statistics. For categorical variables, frequencies and percentages were presented. Data were summarized for the overall population and for subgroups of patients that were stratified by baseline body weight, prior experience with biologics, and the class of biologic that was initiated at baseline.
RESULTS
Baseline Demographics and Disease Characteristics
A total of 100 patients were included in the study (Table 1). Patients had had a diagnosis of psoriasis for an average of 16.4 years; the majority (66.0%) were bio-naive. Overall, patients had significant disease activity at baseline: the mean affected BSA was 13.3%, and the mean assigned PGA score was 3.0. Based on the American Academy of Dermatology’s definition of disease severity in which mild, moderate, and severe psoriasis correspond with <5%, ≥5% to <10%, and ≥10% BSA involvement, respectively,8 the majority of the population consisted of patients with severe psoriasis at baseline (69.0%), with the remaining patients having either moderate (21.0%) or mild (10.0%) disease.
Prescribed Treatments
A total of 9 different biologic agents were prescribed throughout the study (Table 3). These biologics fell within 3 categories based
A total of 100 patients were included in the study (Table 1). Patients had had a diagnosis of psoriasis for an average of 16.4 years; the majority (66.0%) were bio-naive. Overall, patients had significant disease activity at baseline: the mean affected BSA was 13.3%, and the mean assigned PGA score was 3.0. Based on the American Academy of Dermatology’s definition of disease severity in which mild, moderate, and severe psoriasis correspond with <5%, ≥5% to <10%, and ≥10% BSA involvement, respectively,8 the majority of the population consisted of patients with severe psoriasis at baseline (69.0%), with the remaining patients having either moderate (21.0%) or mild (10.0%) disease.
Prescribed Treatments
A total of 9 different biologic agents were prescribed throughout the study (Table 3). These biologics fell within 3 categories based
