key: cord-346287-xg176mi7
authors: Wan, Marilyn T.; Shin, Daniel B.; Winthrop, Kevin L.; Gelfand, Joel M.
title: In response to: “Reply to Research Letter.”
date: 2020-07-29
journal: J Am Acad Dermatol
DOI: 10.1016/j.jaad.2020.07.097
sha: 
doc_id: 346287
cord_uid: xg176mi7

nan

Letter to the Editor 1 2 To the Editor: We appreciate the interest of Rivera-Oyola, Koschitzky, and Lebwohl 1 in our 3 meta-estimate evaluating the risk of respiratory tract infections (RTIs) and symptoms in patients 4

with psoriasis treated with interleukin(IL)-17 pathway inhibiting biologics. 2 The authors make a 5 cogent case for the importance of not cherry-picking data when evaluating drug safety by 6 selecting a few examples in which perhaps patients treated with IL-17 inhibitors have a lower 7 risk of RTIs compared to placebo. The examples they provided are precisely why one needs to 8 look at all the data through an unbiased meta-estimate approach. As we noted in our initial 9

publication, 2 the results demonstrated a statistically significant 31-56% increased risk of RTI in 10 IL-17 targeting biologic treated patients compared to placebo. Sensitivity analyses varying the 11 definition of RTI yielded similar findings. The interpretation of these results is that there is a 12 potential safety signal for RTI associated with IL-17 inhibition. A safety signal is simply defined 13 as a hypothesis between exposure to a drug and an adverse event that warrants further 14 investigation. 3 Taking the same analytical approach, we did not find a safety signal for RTI 15 associated with IL-23 inhibitors. 4 As we pointed out, in the IL-17 analysis, the risk of RTI in 16 clinical trials is difficult to classify because the diagnosis is made clinically, without objective 17

testing. Therefore, the etiology of these symptoms, be they viral, bacterial, fungal, or allergic, is 18

unknown. In the IL-23 analysis, we also noted that the confidence intervals overlap, and 19 therefore, we cannot conclude with certainty that there is a true difference in RTI risk between 20 biologics that target IL-17 versus IL-23. Current data is insufficient to reliably distinguish the 21 risk of becoming infected with SARS-CoV-2 and having worse outcomes from COVID-19 22

illness between our various biologic treatment options for psoriasis. 23

Reply to Research Letter

The risk of respiratory tract infections and symptoms in psoriasis patients treated with IL-17-pathway inhibiting biologics: A metaestimate of pivotal trials relevant to decision-making during the COVID-19 pandemic

Characteristics of drugs safety signals that predict safety related product information update

The Risk of Respiratory Tract Infections in Psoriasis Patients Treated With IL-23-pathway Inhibiting Biologics: A Meta-Estimate of Pivotal Trials Relevant to Decision-Making During the COVID-19 Pandemic