Efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: Phase 3 randomized, double-blind, placebo-controlled study (spirit 2)

All results were statistically significant compared to placebo (p < 0.0001).

“All results were statistically significant compared to the placebo (p < 0.0001).”

Response rates for dysmenorrhea and non-menstrual pelvic pain were maintained or increased after 24 weeks of relugolix treatment.

“Response rates for dysmenorrhea and non-menstrual pelvic pain were maintained or increased after 24 weeks of treatment.”

Mean percentage BMD changes in the lumbar spine from baseline to week 24 in the relugolix CT and delayed relugolix CT arms were −0.70% and −1.99% in SPIRIT-1 and −0.78% and −1.92% in SPIRIT-2.

“Mean percentage BMD changes in the lumbar spine from baseline to week 24 in the relugolix CT and delayed relugolix CT arms were respectively −0.70 % and −1.99% in SPIRIT-1 and −0.78% and −1.92% in SPIRIT-2.”

Relugolix CT enhanced daily functioning, as demonstrated by the EHP-30 pain score domain at week 24 (p < 0.0001 in both studies).

“Relugolix CT enhanced daily functioning, as demonstrated by the EHP-30 pain score domain at week 24 (p < 0.0001 in both studies)”

Percentages of women showing a mean reduction in NRS scores of ≥2.8 points for dysmenorrhea and ≥2.1 points for non-menstrual pelvic pain at week 24 were 75.5% and 58.5% in the relugolix CT arm in SPIRIT-1, and 75.2% and 66% in the relugolix CT arm in SPIRIT-2.

“Percentages of women showing a mean reduction in NRS scores of ≥2.8 points for dysmenorrhea and ≥2.1 points for non-menstrual pelvic pain at week 24 were respectively 75.5% and 58.5% in the relugolix CT arm in SPIRIT-1, and 75.2% and 66% in the relugolix CT arm in SPIRIT-2.”

Oral relugolix CT taken once daily significantly reduced dysmenorrhea and non-menstrual pelvic pain in women with endometriosis compared to placebo.

“In conclusion, oral relugolix CT taken once daily significantly reduced dysmenorrhea and non-menstrual pelvic pain in women with endometriosis compared to a placebo.”

Dysmenorrhea decreased rapidly from severe at baseline to mild by week 8 and was sustained through week 24 in 73% and 75% of women in SPIRIT-1 and -2, respectively.

“Dysmenorrhea decreased rapidly from severe at baseline to mild by week 8 and was sustained through to week 24 in 73% and 75% of women in SPIRIT-1 and -2, respectively.”

In both phase III trials SPIRIT-1 and SPIRIT-2, a similar pattern was observed in responder rates for dysmenorrhea and non-menstrual pelvic pain, with significant differences compared to placebo at 12 weeks in the relugolix CT arm.

“A similar pattern was observed in responder rates for dysmenorrhea and non-menstrual pelvic pain, with significant differences compared to the placebo at 12 weeks in the relugolix CT arm in both SPIRIT-1 and -2.”

These findings were statistically significant in SPIRIT-1 and -2 (p = 0.0149 and p = 0.0371, respectively).

“These findings were also statistically significant in SPIRIT-1 and -2 (p = 0.0149 and p = 0.0371, respectively).”

Relugolix CT is well tolerated, the incidence of vasomotor symptoms is similar to placebo, and BMD is maintained over 24 weeks.

“Relugolix CT is well tolerated, the incidence of vasomotor symptoms is similar to the placebo, and BMD is maintained over 24 weeks.”

Mean percentage hot flushes in the relugolix CT and delayed relugolix CT groups at week 24 were 10.4% and 33.6% in SPIRIT-1 and 13.6% and 35% in SPIRIT-2.

“Mean percentage hot flushes in the relugolix CT and delayed relugolix CT groups at week 24 were 10.4% and 33.6% in SPIRIT-1 and 13.6% and 35% in SPIRIT-2 [118,119].”

Relugolix CT yielded significant improvements in dyspareunia, with 40% and 46% reductions from baseline in NRS scores (mean change).

“Relugolix CT yielded significant improvements in dyspareunia, with 40% and 46% reductions from baseline in NRS scores (mean change).”