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Clinical Trial
. 2024 Sep 27:16:1583-1593.
doi: 10.2147/IJWH.S467041. eCollection 2024.

Pilot Study of IL-1 Antagonist Anakinra for Treatment of Endometriosis

Renee T Sullender  1 , Ravi K Agarwal  2 , Marni B Jacobs  1 , Jocelyn M Wessels  3 , Warren G Foster  3 , Sanjay K Agarwal  1
Affiliations
Clinical Trial

Pilot Study of IL-1 Antagonist Anakinra for Treatment of Endometriosis

Renee T Sullender et al. Int J Womens Health. .

Abstract

Purpose: To evaluate the impact of an interleukin-1 (IL-1) antagonist anakinra (Kineret®) on endometriosis-related quality of life (QoL), pain, and inflammatory biomarkers.

Methods: This was a single-site, randomized, double-blinded, placebo-controlled, cross-over pilot clinical study of patients recruited at an academic specialty clinic. Eligible participants were females aged 18-45 years with menstrual cycles every 24-32 days. Subjects had moderate to severe dysmenorrhea and either a surgical diagnosis of endometriosis or an endometrioma on imaging. Subjects were randomly assigned in a double-blind fashion to receive either the study drug or placebo administered as daily injections during the first 3 periods and then the alternate intervention for the next 3 periods.

Results: Fifteen subjects completed the 6 menstrual cycle study. After each period, they completed the Endometriosis Health Profile-30 (EHP-30) QoL questionnaire and an assessment of dysmenorrhea using a 0-100 Visual Analogue Scale (VAS). All domains of the EHP-30 showed a trend towards improvement, with significant improvements in powerlessness (54.5 vs 63.3, p = 0.04) and self-image (58.1 vs 66.7, p = 0.03) on the study drug compared to placebo. The mean dysmenorrhea VAS also trended toward improvement with a score of 37.5 during active treatment and 42.6 with placebo (p = 0.26). No difference in menstrual cycle length was detected (29.3 days vs 27.7 days, p = 0.56). There were significant differences in multiple inflammatory biomarkers between the study drug and placebo, including BDNF, IL-1, and IL-6 among certain groups.

Conclusion: With all EHP-30 domains and the dysmenorrhea VAS showing either a statistical improvement or trend towards improvement, there is justification for a larger study. As no impact on menstrual cycles was detected, anakinra may be a particularly impactful option for women desiring fertility. Additional evaluation is needed on the role of anakinra on inflammatory markers given significant reductions were identified in multiple biomarkers.

Keywords: IL-1 antagonist; Kineret; anakinra; endometriosis; inflammation; pelvic pain; quality of life.

Plain language summary

Endometriosis is a common gynecologic disease afflicting millions of patients. Anakinra is an IL-1 antagonist currently used for treatment of rheumatoid arthritis which has been found to improve quality of life measures for patients with endometriosis. Anakinra also reduces levels of biomarkers known to be associated with endometriosis-related inflammation. More study is needed on the role of anakinra in improving endometriosis symptoms.

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Conflict of interest statement

Dr Foster and Dr Wessels are Co-Founders of Afynia Laboratories, a medical diagnostic company, and hold several patents unrelated to the treatment of endometriosis. The other authors report no conflicts of interest in this work. An abstract of this paper was presented at the 2023 AAGL Conference as a poster with interim findings. The poster’s abstract was published in the Journal of Minimally Invasive Gynecology Supplement: https://www.sciencedirect.com/science/article/pii/S1553465023006738

Figures

Figure 1
Figure 1
Group A and B BDNF Levels: Paired Data. * Denotes p ≤ 0.05 and *** denotes p ≤0.001.
Figure 2
Figure 2
Group A and B BDNF Levels: All Participants’ Data.
Figure 3
Figure 3
Wilcoxon Matched-Pairs Signed Rank Test Analysis of Average BDNF Levels. (A) Participants with Complete Blood Draws for 6 Menstrual Cycles, **** Denotes p ≤ 0.0001. (B) All Participants, ns denotes p >0.05 (no significance).
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