Treatment of Deep Infiltrative Endometriosis with Methotrexate Carried in Lipid Core Nanoparticles (LDE): A Pilot Study

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Study Objective To assess the safety and efficacy of intravenous methotrexate carried in lipid core nanoparticles (LDE-ddMtx) in women with deep infiltrative endometriosis (DIE) for a 180-day period. Design Pilot, cohort study. Setting Tertiary, academic hospital. Patients or Participants Women over 18 years with bowel endometriosis with VAS pain score equal or higher than 7 (n=11), diagnosed by transvaginal ultrasound (TVUS). Interventions LDE-ddMtx with body surface dosage of 25 (n=3) or 50 (n=8) mg/m2. When two doses were applied, it was given one week interval between them. Measurements and Main Results Women presented 30-49 years, were primiparous (54.55%), and overweight (BMI=26.16±6.50). Eight women used hormonal medication, and nine, non-hormonal drugs. Most of women did not report any severe adverse effects during LDE-ddMtx infusion (54.54%); however, late effects such as nausea (n=7) and abdominal pain (n=6) were the most reported symptoms. Dyspareunia (p=0.001) and dyschaezia (p=0.021) VAS scores have significantly reduced between baseline/90/120/180 days; differences within dyspareunia were noticed between baseline and 120 (p=0.026) / 180 (p=0.027) days; about dyschaezia, between baseline and 180 days (p=0.027) or 90/180 days (p=0.041). Dysmenorrhea (p=0.075) and acyclic pain (p=0.067) presented a reduction on VAS scores, but it was not statistically significant. About the bowel endometriotic lesions seen by US, no significant differences about its size/diameter were found in all assessments. No hepatic or hormonal changes were noticed during drug administration. Anti-mullerian hormone reduced after 180 days, but this was not significant (p=0.059). Subgroup analysis about the dosage found differences in the dysmenorrhea(p=0.024) and dyspareunia(p=0.034) scores, but interaction between dosages and interval follow-up did not find any associated variable. Conclusion LDE-ddMtx significantly reduced dyspareunia and dyschaezia VAS scores in DIE women in a 180-day period. However, no differences were perceived in bowel lesions by TVUS. Further studies, with a control group and larger sample are needed to confirm these findings and provide external validity to use in clinical scenarios. To assess the safety and efficacy of intravenous methotrexate carried in lipid core nanoparticles (LDE-ddMtx) in women with deep infiltrative endometriosis (DIE) for a 180-day period. Pilot, cohort study. Tertiary, academic hospital. Women over 18 years with bowel endometriosis with VAS pain score equal or higher than 7 (n=11), diagnosed by transvaginal ultrasound (TVUS). LDE-ddMtx with body surface dosage of 25 (n=3) or 50 (n=8) mg/m2. When two doses were applied, it was given one week interval between them. Women presented 30-49 years, were primiparous (54.55%), and overweight (BMI=26.16±6.50). Eight women used hormonal medication, and nine, non-hormonal drugs. Most of women did not report any severe adverse effects during LDE-ddMtx infusion (54.54%); however, late effects such as nausea (n=7) and abdominal pain (n=6) were the most reported symptoms. Dyspareunia (p=0.001) and dyschaezia (p=0.021) VAS scores have significantly reduced between baseline/90/120/180 days; differences within dyspareunia were noticed between baseline and 120 (p=0.026) / 180 (p=0.027) days; about dyschaezia, between baseline and 180 days (p=0.027) or 90/180 days (p=0.041). Dysmenorrhea (p=0.075) and acyclic pain (p=0.067) presented a reduction on VAS scores, but it was not statistically significant. About the bowel endometriotic lesions seen by US, no significant differences about its size/diameter were found in all assessments. No hepatic or hormonal changes were noticed during drug administration. Anti-mullerian hormone reduced after 180 days, but this was not significant (p=0.059). Subgroup analysis about the dosage found differences in the dysmenorrhea(p=0.024) and dyspareunia(p=0.034) scores, but interaction between dosages and interval follow-up did not find any associated variable. LDE-ddMtx significantly reduced dyspareunia and dyschaezia VAS scores in DIE women in a 180-day period. However, no differences were perceived in bowel lesions by TVUS. Further studies, with a control group and larger sample are needed to confirm these findings and provide external validity to use in clinical scenarios.