ONE treatment that controls heavy menstrual bleeding due
to fibroids1

Study design: ORIAHNN was studied in two 6-month Phase 3 pivotal studies (ELARIS UF-1 AND UF-2) including premenopausal women aged 25-53 with heavy menstrual bleeding associated with uterine fibroids and in an additional 6-month extension study (UF-EXTEND), which did not include a placebo arm1-3

ORIAHNN controls heavy menstrual bleeding due to fibroids

Proportion of women achieving a clinically meaningful bleeding reduction at Final Month1†

ELARIS UF-2

ELARIS UF-1

ORIAHNN

77%

(n=189)

Placebo

11%

(n=94)

P<0.001

Final Month

The last 28 days before and including the last treatment visit date or the last dose date. This can occur anytime from Month 1 to 6 in the pivotal studies.1


Results were similar in ELARIS UF-1 [ORIAHNN (n=206): 69%; placebo (n=102): 9%, P<0.001].

ELARIS UF-1

Results were similar in ELARIS UF-1 [ORIAHNN (n=206): 69%; placebo (n=102): 9%, P<0.001].

What did it take to achieve a
clinically meaningful bleeding
reduction?

Measuring Cup Icon.

≥50% bleeding volume reduction from baseline to Final Month1†

AND

Measuring Cup Icon.

<80 mL bleeding volume at Final Month1†

=

responder

=  responder

Quick and continued menstrual bleeding reduction with ORIAHNN

Over 50% bleeding reduction at Month 1 and continued reduction seen at Months 3 and 64

Menstrual blood loss (MBL) reduction in ELARIS UF-24

Graph depicting reduction in menstrual bleeding after 6 months with ORIAHNN as compared to placebo. Graph depicting reduction in menstrual bleeding after 6 months with ORIAHNN as compared to placebo. Graph depicting reduction in menstrual bleeding after 6 months with ORIAHNN as compared to placebo.

Results were similar in ELARIS UF-1 [Month 1: ORIAHNN (n=187), 52% (124.3 mL) mean reduction, MBL=106 mL; placebo (n=95), 13% (33.1 mL) mean reduction, MBL=226 mL; Month 3: ORIAHNN (n=172), 82% (186.8 mL) mean reduction, MBL=44 mL; placebo (n=85), 4% (0.1 mL) mean reduction, MBL=263 mL; Month 6: ORIAHNN (n=132), 81% (188.5 mL) mean reduction, MBL=41 mL; placebo (n=71), 3% (8.8 mL) mean reduction, MBL=240 mL].

On average, normal menstrual bleeding in women without fibroids is 30-47 mL5,6

Regardless of her characteristics, ORIAHNN controlled her heavy menstrual bleeding

Proportion of women who met the primary endpoint in ELARIS UF-1 and UF-2 at Final Month1,7-12†

Subgroup analyses of the primary endpoint were explored to assess potential differences in treatment effect across subgroup levels and were not controlled for multiplicity.

Click on a subgroup to view results

Select a subgroup to view results

Disease severity subgroups

Baseline ranges and percentages for race and ethnicity depict the entire study population (N=790), while the subgroup analyses depict the ORIAHNN group alone.

72%

Overall pooled results for primary endpoint in ELARIS UF-1 and UF-2 (n=395)7

ORIAHNN delivered clinically significant# improvement in Hgb levels at Month 61,13

In women with anemia who took ORIAHNN

Proportion of women with baseline Hgb ≤10.5 g/dL who achieved a >2 g/dL increase at Month 6

ELARIS UF-2

ELARIS UF-1

ORIAHNN

50%

(n=48)

Placebo

21%

(n=24)

P=0.02

Month 6

Results were similar in ELARIS UF-1 [ORIAHNN (n=52): 62%, placebo (n=31): 16%, P<0.001].

ELARIS UF-1

Results were similar in ELARIS UF-1 [ORIAHNN (n=52): 62%, placebo (n=31): 16%, P<0.001].

Over 90% of women with baseline Hgb ≤10.5 g/dL took supplemental iron.

During the ELARIS UF-1 and UF-2 trials 2 women (0.5%) had heavy menstrual bleeding and required blood transfusion due to anemia (a serious adverse event).

The baseline Hgb in the anemic ORIAHNN-treated women evaluated in this endpoint was ≤10.5 g/dL1

Amenorrhea with ORIAHNN—defined as zero bleeding or spotting2

Proportion of women who experienced Amenorrhea at Final Month2

Percentage of women with Amenorrhea was a non-ranked secondary endpoint. These results were not controlled for multiplicity.

ELARIS UF-2

ELARIS UF-1

ORIAHNN

53%

(n=172)

Placebo

5%

(n=85)

Final Month

The last 28 days before and including the last treatment visit date or the last dose date. This can occur anytime from Month 1 to 6 in the pivotal studies.1

Results were similar in ELARIS UF-1 [ORIAHNN (n=183): 48%, placebo (n=91): 4%].

ELARIS UF-1

Results were similar in ELARIS UF-1 [ORIAHNN (n=183): 48%, placebo (n=91): 4%].

In ORIAHNN clinical trials, Amenorrhea was defined as having zero bleeding or spotting during the Final Month,† which was a 28-day interval1,2

Quality-of-life and symptom severity results

Health-related quality-of-life scores in ELARIS UF-22,14-17

Total scores for HRQoL range from 0 to 100, with higher scores indicating a better HRQoL

  •  
    ORIAHNN
  •  
    Placebo

86: HRQoL score for normal control group (women without fibroids)14,15

Symptom severity scores in ELARIS UF-22,14-17

Scores for symptom severity range from 0 to 100, with higher scores indicating increased severity

  •  
    ORIAHNN
  •  
    Placebo

23: Symptom severity score for normal control group (women without fibroids)14,15

The UFS-QOL is a questionnaire that measures the impact of UF symptoms, including measures of heavy menstrual bleeding on quality of life across 2 scales: HRQoL and symptom severity.14,15

UFS-QOL data from ELARIS UF-1 and UF-2 was a non-ranked endpoint that was not controlled for multiplicity.2

In a study evaluating the UFS-QOL questionnaire, which includes heavy menstrual bleeding measures, 29 control patients had an average symptom severity score of 23 and an average HRQoL total score of 86.14

UFS-QOL=Uterine Fibroid Symptom and Quality of Life.

Change in fibroid symptoms

PGIC questionnaire evaluated the assessment of whether severity of symptoms improved or worsened in premenopausal women who suffer from heavy menstrual bleeding due to fibroids18

PGIC results at Month 6 in ELARIS UF-218

Patients' assessment of whether severity of symptoms improved or worsened was a non-ranked endpoint and was not controlled for multiplicity.2

Click on a symptom to view results

Select a symptom to view results

Fibroid symptoms

PGIC=Patient Global Impression of Change.

BMI=body mass index; FIGO score=The International Federation of Gynecology and Obstetrics score for classifying leiomyomas.

*The ORIAHNN free trial provides a single 28-day trial supply of ORIAHNN at no cost to new patients residing in the United States with a valid prescription for an FDA-approved indication of ORIAHNN and who enroll in Oriahnn Complete. The trial is intended solely to allow new patients not currently taking ORIAHNN to determine with their healthcare provider whether ORIAHNN is right for them. There is no obligation to continue use of ORIAHNN after the trial has concluded and this program does not guarantee insurance coverage. Eligible patients are limited to one 28-day trial supply and may not re-enroll. The ORIAHNN trial supply will be dispensed only through an AbbVie-authorized pharmacy to the patient’s home address and may not be sold or further distributed. No claims for payment may be submitted to any third party insurance plan for product dispensed by program. AbbVie reserves the right to change or discontinue the trial at any time without notice. The trial is not health insurance and is not a discount, coupon, rebate or financial assistance program. Limitations may apply.

Final Month in ELARIS UF-1 and UF-2 is defined as the last 28 days before and including the last treatment visit date or the last dose date.

Submucosal: FIGO score 0-3; Intramural: FIGO score 4; Subserosal: FIGO score 5-8.

§Primary fibroid volume is defined as largest fibroid identified by ultrasound.

||A uterus that is 14-16 weeks in size is approximately 355-460 cm3.

For primary fibroid volume only, N=778.

#A >2 g/dL increase in Hgb levels.