INTRODUCTION
Understanding of the immunologic basis of chronic plaque psoriasis has led to the development of several classes of biological agents, primarily monoclonal antibodies, including inhibitors of tumor necrosis factor (TNF), interleukin-12/23 (IL-12/23), interleukin-17 (IL-17), and interleukin-23 (IL-23).
Studies have explored alternate dosing regimens to improve adherence, however continuous therapy appears to be superior in efficacy compared to as-needed treatment for several agents.1-5 Nevertheless, temporary treatment interruption may occur in clinical practice for a number of reasons, such as elective surgery, hospitalization, illness such as COVID-19, pregnancy and breastfeeding, live vaccination, travel, and financial considerations. Conversely, some patients who have achieved and maintained skin clearance may request a trial off therapy. However, there are some concerns that interrupting biologic therapy may result in a subsequent diminished response and/or development of anti-drug antibodies. We reviewed the efficacy, safety and immunogenicity data of interrupted biologic therapy in clinical trials.
Studies have explored alternate dosing regimens to improve adherence, however continuous therapy appears to be superior in efficacy compared to as-needed treatment for several agents.1-5 Nevertheless, temporary treatment interruption may occur in clinical practice for a number of reasons, such as elective surgery, hospitalization, illness such as COVID-19, pregnancy and breastfeeding, live vaccination, travel, and financial considerations. Conversely, some patients who have achieved and maintained skin clearance may request a trial off therapy. However, there are some concerns that interrupting biologic therapy may result in a subsequent diminished response and/or development of anti-drug antibodies. We reviewed the efficacy, safety and immunogenicity data of interrupted biologic therapy in clinical trials.
MATERIALS AND METHODS
A systematic review was performed according to PRISMA guidelines. An electronic search was conducted in the MEDLINE, Embase and ACP Journal Club databases, from date of inception to August 26, 2020. We combined the terms "psoriasis" with "infliximab, adalimumab, etanercept, certolizumab, ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, risankizumab, or tildrakizumab" and "withdraw, re-treat, interrupt, intermittent, or restart (and variations of each word root)". Titles and abstracts were reviewed for relevant studies based on selection criteria, and full texts were reviewed to determine final inclusion. Reference lists from included articles were also reviewed for other relevant studies.
Selection Criteria
Final selection was based on five main criteria: full-text article in English (abstracts excluded), clinical trial (randomized controlled trials, non-randomized clinical trials or long-term extension trials), intervention (biologics in common use as outlined in the search), study population (chronic plaque psoriasis), and a withdrawal and re-treatment design in the study with available safety and efficacy data.
Data Extraction And Analysis
Data on study design, efficacy, and safety outcomes (including rate of response, rate of relapse, median time to relapse, safety profile, and rate of anti-drug antibodies) were extracted.
Selection Criteria
Final selection was based on five main criteria: full-text article in English (abstracts excluded), clinical trial (randomized controlled trials, non-randomized clinical trials or long-term extension trials), intervention (biologics in common use as outlined in the search), study population (chronic plaque psoriasis), and a withdrawal and re-treatment design in the study with available safety and efficacy data.
Data Extraction And Analysis
Data on study design, efficacy, and safety outcomes (including rate of response, rate of relapse, median time to relapse, safety profile, and rate of anti-drug antibodies) were extracted.
RESULTS
The initial database search yielded 678 results. After review of abstracts and titles, 40 relevant articles were identified, and
