†Statistical significance for dyspareunia was not achieved with the 150 mg QD dose of ORILISSA.
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Clinical study design: Two robust similar multicenter, double-blind, randomized, prospective, placebo-controlled Phase 3 trials of 6-month treatment at 2 doses (N=1686)1
Rigorous responder
definition included both:
Clinically meaningful
pain reduction*
AND
Stable or decreased
NSAID or opioid use
*Women were defined as responders if they experienced clinically meaningful pain reduction and stable/decreased rescue analgesic use for endometriosis-associated pain. Clinically meaningful reduction in pain was defined as a calculated threshold of improvement in pain score in each study. The threshold was determined based on an analysis of the change in pain score that corresponded to “much improved” or “very much improved” on the Patient Global Impression of Change Questionnaire.
Results shown below are from ELARIS EM-1. Results in ELARIS EM-2 were consistent and can be viewed by clicking on the ELARIS EM-2 buttons.
ORILISSA 150 mg QD
Co-primary endpoint: Responder rate for dysmenorrhea at month 31,3‡
ELARIS EM-1
P≤0.001 vs placebo
Secondary endpoints: Mean dysmenorrhea score reduction from baseline to month 6 (ranked) and mean percent reduction over 6 months (non-ranked)1,3-5§
Mean baseline dysmenorrhea score: 2.2 (on a scale from 0 to 3)
Mean change in pain score from baseline to month 6 was a ranked secondary endpoint. All other endpoints shown above were non-ranked secondary endpoints and multiplicity adjustments were not applied.
Co-primary endpoint: Responder rate for NMPP at month 31,3‡
ELARIS EM-1
P≤0.001 vs placebo
Secondary endpoints: Mean NMPP score reduction from baseline to month 6 (ranked) and mean percent reduction over 6 months (non-ranked)1,3-5§
Mean baseline NMPP score: 1.6 (on a scale from 0 to 3)
Mean change in pain score from baseline to month 6 was a ranked secondary endpoint. All other endpoints shown above were non-ranked secondary endpoints and multiplicity adjustments were not applied.
Secondary endpoint: Mean dyspareunia reduction from baseline to month 3 (ranked)1,3,4§
ELARIS EM-1
Mean change in pain score from baseline to month 3 was a ranked secondary endpoint.
Quality of life was studied using the EHP-30 questionnaire
QoL dimensions
studied using EHP-30
Pain|| scores (NON-RANKED SECONDARY ENDPOINT)3,7,8
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Emotional well-being scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Sexual intercourse¶ scores (NON-RANKED SECONDARY ENDPOINT)1,3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Control and powerlessness scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Self-image scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Social support scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Pain|| scores (NON-RANKED SECONDARY ENDPOINT)3,7,8
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Emotional well-being scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Sexual intercourse¶ scores (NON-RANKED SECONDARY ENDPOINT)1,3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Control and powerlessness scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Self-image scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Social support scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
‡Assessed from baseline to the analysis month greater or equal to the following calculated, threshold of improvement in pain score in each study: Dysmenorrhea responder thresholds were ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder thresholds were ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2. The threshold was determined based on analysis of the change in pain score corresponding to "much improved" or "very much improved" on the Patient Global Impression of Change Questionnaire.
§Baseline and monthly visit values were based on a 35-day mean.
IIEHP-30 questions for this dimension assessed the effects of endometriosis pain on quality-of-life, and did not specify dysmenorrhea, non-menstrual pelvic pain, or dyspareunia only.
¶Mean reduction in dyspareunia score from baseline was not statistically significant at the 150 mg QD dose of ORILISSA in EM-1 and EM-2.
ORILISSA 200 mg BID
Co-primary endpoint: Responder rate for dysmenorrhea at month 31,3‡
ELARIS EM-1
P≤0.001 vs placebo
Secondary endpoints: Mean dysmenorrhea score reduction from baseline to month 6 (ranked) and mean percent reduction over 6 months (non-ranked)1,3-5§
Mean baseline dysmenorrhea score: 2.2 (on a scale from 0 to 3)
Mean change in pain score from baseline to month 6 was a ranked secondary endpoint. All other endpoints shown above were non-ranked secondary endpoints and multiplicity adjustments were not applied.
Co-primary endpoint: Responder rate for NMPP at month 31,3‡
ELARIS EM-1
P≤0.001 vs placebo
Secondary endpoints: Mean NMPP score reduction from baseline to month 6 (ranked) and mean percent reduction over 6 months (non-ranked)1,3-5§
Mean baseline NMPP score: 1.6 (on a scale from 0 to 3)
Mean change in pain score from baseline to month 6 was a ranked secondary endpoint. All other endpoints shown above were non-ranked secondary endpoints and multiplicity adjustments were not applied.
Secondary endpoints: Mean dyspareunia score reduction from baseline to month 3 (ranked) and mean percent reduction over 3 months (non-ranked)1,3-5§
Quality of life was studied using the EHP-30 questionnaire
QoL dimensions
studied using EHP-30
Pain|| scores (NON-RANKED SECONDARY ENDPOINT)3,7,8
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Emotional well-being scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Sexual intercourse¶ scores (NON-RANKED SECONDARY ENDPOINT)1,3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Control and powerlessness scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Self-image scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Social support scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Pain|| scores (NON-RANKED SECONDARY ENDPOINT)3,7,8
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Emotional well-being scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Sexual intercourse¶ scores (NON-RANKED SECONDARY ENDPOINT)1,3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Control and powerlessness scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Self-image scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Social support scores (ADDITIONAL VARIABLE)3,7
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
‡Assessed from baseline to the analysis month greater or equal to the following calculated, threshold of improvement in pain score in each study: Dysmenorrhea responder thresholds were ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder thresholds were ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2. The threshold was determined based on analysis of the change in pain score corresponding to "much improved" or "very much improved" on the Patient Global Impression of Change Questionnaire.
§Baseline and monthly visit values were based on a 35-day mean.
IIEHP-30 questions for this dimension assessed the effects of endometriosis pain on quality-of-life, and did not specify dysmenorrhea, non-menstrual pelvic pain, or dyspareunia only.
¶Mean reduction in dyspareunia score from baseline was not statistically significant at the 150 mg QD dose of ORILISSA in EM-1 and EM-2.
ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.
These are not all the possible side effects of ORILISSA.
Safety and effectiveness of ORILISSA in patients less than 18 years of age have not been established.
US-ORIL-200330
For more information, please click here for full Prescribing Information.
1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc. 2. Taylor HS, Giudice LC, Lessey BA, et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist. N Engl J Med. 2017;377(1):28-40. 3. Data on file. ABVRRTI66651. 4. Surrey E, Taylor HS, Giudice L, et al. Long-term outcomes of elagolix in women with endometriosis: results from two extension studies. Obstet Gynecol. 2018;132(1):147-160.
ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis. Limit the duration of use based on the dose and coexisting condition.
These are not all the possible side effects of ORILISSA.
Safety and effectiveness of ORILISSA in pediatric patients have not been established.
US-ORIL-210045
For more information, please click here for full Prescribing Information.
1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc. 2. Fuldeore MJ, Soliman AM. Prevalence and symptomatic burden of diagnosed endometriosis in the United States: national estimates from a cross-sectional survey of 59,411 women. Gynecol Obstet Invest. 2017;82(5):453-461. 3. Taylor HS, Giudice LC, Lessey BA, et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist. N Engl J Med. 2017;377(1):28-40. 4. Data on file. ABVRRTI70850. 5. Data on file. ABVRRTI66651. 6. Data on file. ABVRRTI72729. 7. Data on file. ABVRRTI67669. 8. Jenkinson C, Kennedy S, Jones G. Evaluation of the American version of the 30-item Endometriosis Health Profile (EHP-30). Qual Life Res. 2008;17:1147-1152. doi:10.1007/s11136-008-9403-9. 9. Data on file. ABVRRTI72377.
Social support scores (ADDITIONAL VARIABLE)3,9
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Quality-of-life (QoL) scores were measured using the Endometriosis Health Profile (EHP-30), a disease-specific, self-administered questionnaire used to measure health-related quality of life in women with endometriosis.
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and were not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error. Lower scores indicate better quality of life.
Self-image scores (ADDITIONAL VARIABLE)3,9
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Mean baseline QoL score for self-image: 45
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Control and powerlessness scores (ADDITIONAL VARIABLE)3,9
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Mean baseline QoL score for
control & powerlessness: 62
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Sexual intercourse* scores (ADDITIONAL VARIABLE)1,3,9
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
*Mean reduction in dyspareunia score from baseline was not statistically significant at the 150 mg QD dose of ORILISSA in EM-1 and EM-2.
Mean baseline QoL score for
sexual intercourse: 58
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
*Mean reduction in dyspareunia score from baseline was not statistically significant at the 150 mg QD dose of ORILISSA in EM-1 and EM-2.
Emotional well-being scores (ADDITIONAL VARIABLE)3,9
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Mean baseline QoL score for
emotional well-being: 46
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
Pain* scores (NON-RANKED SECONDARY ENDPOINT)3,8,9
These results were captured as additional variables and endpoints in ELARIS EM-1 and ELARIS EM-2 and not controlled for multiplicity. Nominal values presented are not controlled for a type-1 error.
Decreased scores indicate improvement in QoL dimension.
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
*EHP-30 questions for this dimension assessed the effects of endometriosis pain on quality of life and did not specify dysmenorrhea, non-menstrual pelvic pain, or dyspareunia only.
Mean baseline QoL score for pain: 55
Adapted from Taylor 2017 et al.
LS=least squares.
Each EHP-30 question was scored from 0 (never) to 4 (always) and normalized to a scale of 0-100 for each dimension. Month 0 refers to baseline.
*EHP-30 questions for this dimension assessed the effects of endometriosis pain on quality of life and did not specify dysmenorrhea, non-menstrual pelvic pain, or dyspareunia only.
Co-primary endpoint: Responder rate for dysmenorrhea at month 31,3*
ELARIS EM-2
P≤0.001 vs placebo
Secondary endpoints: Mean dysmenorrhea score reduction from baseline to month 6 (ranked) and mean percent reduction over 6 months (non-ranked)1,3,4,6†
Mean baseline dysmenorrhea score: 2.2 (on a scale from 0 to 3)
Mean change in pain score from baseline to month 6 was a ranked secondary endpoint. All other endpoints shown above were non-ranked secondary endpoints and multiplicity adjustments were not applied.
*Assessed from baseline to the analysis month greater or equal to the following calculated, threshold of improvement in pain score in each study: Dysmenorrhea responder thresholds were ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder thresholds were ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2. The threshold was determined based on analysis of the change in pain score corresponding to "much improved" or "very much improved" on the Patient Global Impression of Change Questionnaire.
†Baseline and monthly visit values were based on a 35-day mean.
Secondary endpoints: Mean dyspareunia score reduction from baseline to month 3 (ranked) and mean percent reduction over 3 months (non-ranked)1,3,4,6*
Mean baseline dyspareunia score: 1.5 (on a scale from 0 to 3)
Mean change in pain score from baseline to month 3 was a ranked secondary endpoint. All other endpoints shown above were non-ranked secondary endpoints and multiplicity adjustments were not applied.
*Baseline and monthly visit values were based on a 35-day mean.
Co-primary endpoint: Responder rate for NMPP at month 31,3*
ELARIS EM-2
P≤0.01 vs placebo
Secondary endpoints: Mean NMPP score reduction from baseline to month 6 (ranked) and mean percent reduction over 6 months (non-ranked)1,3,4,6†
Mean baseline NMPP score: 1.6 (on a scale from 0 to 3)
Mean change in pain score from baseline to month 6 was a ranked secondary endpoint. All other endpoints shown above were non-ranked secondary endpoints and multiplicity adjustments were not applied.
*Assessed from baseline to the analysis month greater or equal to the following calculated, threshold of improvement in pain score in each study: Dysmenorrhea responder thresholds were ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder thresholds were ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2. The threshold was determined based on analysis of the change in pain score corresponding to "much improved" or "very much improved" on the Patient Global Impression of Change Questionnaire.
†Baseline and monthly visit values were based on a 35-day mean.
Co-primary endpoint: Responder rate for NMPP at month 31,3*
ELARIS EM-2
P≤0.001 vs placebo
Secondary endpoints: Mean NMPP score reduction from baseline to month 6 (ranked) and mean percent reduction over 6 months (non-ranked)1,3,4,6†
Mean baseline NMPP score: 1.6 (on a scale from 0 to 3)
Mean change in pain score from baseline to month 6 was a ranked secondary endpoint. All other endpoints shown above were non-ranked secondary endpoints and multiplicity adjustments were not applied.
*Assessed from baseline to the analysis month greater or equal to the following calculated, threshold of improvement in pain score in each study: Dysmenorrhea responder thresholds were ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder thresholds were ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2. The threshold was determined based on analysis of the change in pain score corresponding to "much improved" or "very much improved" on the Patient Global Impression of Change Questionnaire.
†Baseline and monthly visit values were based on a 35-day mean.
