Relugolix Combination Therapy Improves Pain, Functioning, and Quality of Life in Women with Endometriosis: Study

The findings of a new study extended the evaluation of relugolix CT up to 104 weeks, showcasing its potential to provide sustained relief from the pain associated with endometriosis. The study showed that women receiving relugolix CT experienced a significant reduction in pain symptoms, including dysmenorrhea (painful periods), non-menstrual pelvic pain (NMPP), and dyspareunia (pain during intercourse). This marks a substantial improvement in managing one of the most debilitating aspects of endometriosis.

Endometriosis is a chronic condition where tissue similar to the lining of the uterus grows outside the uterus, causing severe pain, irregular bleeding, and potential fertility issues. For many women, endometriosis-associated pain severely impacts daily functioning and overall well-being.

Against the above background, Sawsan As-Sanie, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan, and colleagues aimed to evaluate the impact of relugolix combination therapy (relugolix CT; 40 mg relugolix, 1 mg estradiol, and 0.5 mg norethisterone acetate) over up to two years in the SPIRIT long-term extension study. They focused on its effects on functioning and health-related quality of life (QoL), as measured by the Endometriosis Health Profile (EHP)-30 questionnaire, and examined how changes in QoL domains correlated with improvements in dysmenorrhea and nonmenstrual pelvic pain.

For this purpose, the researchers conducted a long-term extension study of the SPIRIT phase 3 trials involving premenopausal women with moderate-to-severe endometriosis pain who had previously completed the randomized SPIRIT trials. The women enrolled in an 80-week extension, receiving relugolix combination therapy (40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate).

The study assessed changes in health-related quality of life using the EHP-30 questionnaire, with results analyzed through a mixed-effects model. The researchers also examined how improvements in dysmenorrhea and nonmenstrual pelvic pain (NMPP) correlated with changes in QoL scores.

The following were the key findings of the study:

• In the 277 women treated with relugolix combination therapy, the least squares (LS) mean EHP-30 pain domain scores improved by 57.8% at week 24 (LS mean change: −32.8), 66.4% at week 52 (LS mean change: −37.7), and 72.2% at week 104 (LS mean change: −41.3).
• At weeks 24, 52, and 104, respectively, clinically meaningful improvements in pain were seen in 75.9%, 83.6%, and 88.6% of women. Non-pain EHP-30 domain and total scores also showed improvement.
• A positive correlation was observed between changes in dysmenorrhea/NMPP and all EHP-30 domain scores.
• Similar results were seen in the delayed relugolix CT and placebo → relugolix CT groups.

The findings showed that sustained reduction in endometriosis-associated pain observed with relugolix combination therapy over 104 weeks was accompanied by improvements in functioning and health-related quality of life.

"These results further support the findings of the pivotal SPIRIT trials, which demonstrated that relugolix CT significantly reduced dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia compared to placebo in premenopausal women with endometriosis-related pain," the researchers concluded.

Reference:

As-Sanie, S., Abrao, M. S., Reznichenko, G., Wilk, K., Zhong, Y., Perry, J., Hunsche, E., Soulban, G., & Becker, C. M. (2024). Impact of relugolix combination therapy on functioning and quality of life in women with endometriosis-associated pain. Fertility and Sterility, 122(4), 687-695. https://doi.org/10.1016/j.fertnstert.2024.06.009