Table 2.
Primary and secondary efficacy endpoints at 3 and 6 months.
| Placebo | Linzagolix 75 mg | Linzagolix 200 mg + ABT | |||||
|---|---|---|---|---|---|---|---|
| (N = 162) |
(N = 160) |
(N = 162) |
|||||
| Proportion of responders (95% CI) | Proportion of responders (95% CI) | P-value 1 | Proportion of responders (95% CI) | P-value 1 | |||
| Dysmenorrhea at Month 3 | 23.5 (17.5; 30.7) | 44.0 (36.3; 52.0) | <0.001 | 72.9 (65.3; 79.4) | <0.001 | ||
| Non-menstrual pelvic pain at Month 3 | 30.9 (24.1; 38.6) | 38.9 (31.5; 46.9) | 0.279 | 47.3 (39.5; 55.3) | 0.007 | ||
|
| |||||||
| LSM (95% CI) | LSM (95% CI) | Diff with PBO (97.5% CI) | P-value 1 | LSM (95% CI) | Diff with PBO (97.5% CI) | P-value 1 | |
|
| |||||||
| Change from baseline in dysmenorrhea (VRS) after 6 months | −0.66 (−0.79; −0.53) | −1.10 (−1.23; −0.97) | −0.44 (−0.65; −0.23) | <0.001 | −1.83 (−1.96; −1.70) | −1.17 (−1.38; −0.97) | <0.001 |
| Change from baseline in NMPP (VRS) after 6 months | −0.66 (−0.77; −0.56) | −0.84 (−0.95; −0.73) | −0.17 (−0.35; 0.00) | 0.048 | −0.92 (−1.03; −0.82) | −0.26 (−0.43; −0.09) | 0.002 |
| Change from baseline in dyschezia (NRS) | −1.41 (−1.71; −1.12) | −1.98 (−2.28; −1.69) | −0.57 (−1.05; −0.09) | 0.015 | −1.99 (−2.29; −1.70) | −0.58 (−1.05; −0.11) | 0.012 |
| Change from baseline in overall pelvic pain (NRS) at 6 months | −2.19 (−2.55; −1.84) | −2.84 (−3.20; −2.48) | −0.65 (−1.23; −0.07) | 0.024 | −3.39 (−3.74; −3.03) | −1.19 (−1.77; −0.62) | <0.001 |
| Change from baseline in EHP-30 Pain dimension: analysis of covariance (FAS) at 6 months | −19.47 (−22.66; −16.28) | −27.37 (−30.50; −24.25) | −7.90 (−13.01; −2.79) | 0.001 | −35.60 (−38.73; −32.48) | −16.13 (−21.24; −11.02) | <0.001 |
| Change from baseline in dyspareunia (VRS) at 6 months: analysis of covariance (FAS) | −0.82 (−0.97; −0.66) | −1.04 (−1.21; −0.88) | −0.23 (−0.49; 0.03) | 0.100 | −1.01 (−1.18; −0.85) | −0.20 (−0.46; 0.07) | 0.184 |
|
| |||||||
| % of responders (95%CI) | % of responders (95%CI) | OR 2 (97.5% CI) | P-value 1 | % of responders (95%CI) | OR 2 (97.5% CI) | P-value 1 | |
|
| |||||||
| No analgesic use for EAP during the preceding 4-week period at Month 6 | 13.2 (8.9; 19.2) | 30.9 (23.8; 39.1) | 2.95 (1.58; 5.50) | <0.001 | 44.5 (36.3; 52.9) | 5.27 (2.83; 9.82) | <0.001 |
| No opiate use for EAP during the preceding 4-week period at Month 6 | 97.0 (92.5; 98.9) | 93.8 (88.5; 96.8) | 0.47 (0.12; 1.82) | 0.420 | 97.0 (92.7; 98.8) | 0.99 (0.22; 4.51) | 1.000 |
ABT: add-back therapy; EAP: endometriosis-associated pain; EHP-30: Endometriosis Health Profile-30; FAS: full analysis set; LSM: least square mean; NMPP: non-menstrual pelvic pain; NRS: numeric rating scale; OR: odds ratio; PBO: placebo; VRS: verbal rating scale.
Scores were computed as mean of daily assessments on the last 28 days prior to Month 6 or discontinuation.
Analysis of covariance with change from baseline as response variable, and baseline value, treatment as covariates.
EHP-30 Pain Score at Month 6 or discontinuation. EHP-30 Pain Score was computed as the sum of each pain question score/(number of items × 4) × 100 and ranges from 0 (best possible health status) to 100 (worst possible health status).
For dyspareunia, subjects not sexually active for other reasons than endometriosis have missing value.
Analgesic and opiate use for EAP as collected in eDiary and Concomitant Medication page on the last 28 days prior to Month 6 or discontinuation.
Bonferroni-corrected p-value. A fixed-sequence testing strategy was used to account for multiplicity. The LGX 200 mg + ABT group demonstrated statistical significant differences for both co-primary endpoints. The LGX 75 mg group was not found to be statistically significantly compared to placebo for the NMPP co-primary endpoint.
Odds ratios and 97.5% CI estimated with logistic regression model with no analgesic use/no opiate use in the last 28 days on treatment prior to Month 6 as response variable, treatment group as the main effect and including the baseline analgesic use/opiate use as a covariate.