Dear Editor,
Interleukin 36 (IL-36) inhibitors block the interaction of IL-36 and its receptor, attenuating the downstream inflammatory signaling cascade.1 Given the therapeutic potential for IL-36 inhibitors in treating dermatological conditions, adequate representation among trial participants is warranted.2 Clinical trials serve an important role in providing evidence for the safety and efficacy of novel therapies for skin conditions.3 To gain insights into the current landscape of clinical trials research related to IL-36 inhibitors, a systematic search was conducted to identify relevant studies.
A clinicaltrials.gov search was conducted on May 19th, 2023 using key words (IL-36 antibody, IL-36 inhibitor, IL-36, interleukin 36, spesolimab, BI-655130, imsidolimab, and ANB019), yielding a total of 46 studies. After applying exclusion criteria, 6 studies were included (Figure 1).
Total enrollment across all six trials was 382 patients, with 71% of participants being female. The pooled mean participant age was 49.41 years (standard deviation 11.83). All included trials were industry funded and Phase 2. All but one trial had at least one US-based trial site. The majority of participants were non-Hispanic (92%) and White (64%), with 4.5% (17/382) Black or African American (Table 1). No American Indian or Alaska Native participants were enrolled. Two trials investigated use of imsidolimab, and 4 trials focused on spesolimab.
We report underrepresentation of Hispanic and Black or African American participants in IL-36 inhibitor dermatology trials. Similarly, in a 2021 study of key clinical trials of U.S. FDA-approved dermatology drugs 1995-2019, Blacks and Asians were consistently underrepresented, comprising 9.8% and 5.5% of participants respectively.4 In addition, in a
Interleukin 36 (IL-36) inhibitors block the interaction of IL-36 and its receptor, attenuating the downstream inflammatory signaling cascade.1 Given the therapeutic potential for IL-36 inhibitors in treating dermatological conditions, adequate representation among trial participants is warranted.2 Clinical trials serve an important role in providing evidence for the safety and efficacy of novel therapies for skin conditions.3 To gain insights into the current landscape of clinical trials research related to IL-36 inhibitors, a systematic search was conducted to identify relevant studies.
A clinicaltrials.gov search was conducted on May 19th, 2023 using key words (IL-36 antibody, IL-36 inhibitor, IL-36, interleukin 36, spesolimab, BI-655130, imsidolimab, and ANB019), yielding a total of 46 studies. After applying exclusion criteria, 6 studies were included (Figure 1).
Total enrollment across all six trials was 382 patients, with 71% of participants being female. The pooled mean participant age was 49.41 years (standard deviation 11.83). All included trials were industry funded and Phase 2. All but one trial had at least one US-based trial site. The majority of participants were non-Hispanic (92%) and White (64%), with 4.5% (17/382) Black or African American (Table 1). No American Indian or Alaska Native participants were enrolled. Two trials investigated use of imsidolimab, and 4 trials focused on spesolimab.
We report underrepresentation of Hispanic and Black or African American participants in IL-36 inhibitor dermatology trials. Similarly, in a 2021 study of key clinical trials of U.S. FDA-approved dermatology drugs 1995-2019, Blacks and Asians were consistently underrepresented, comprising 9.8% and 5.5% of participants respectively.4 In addition, in a
