IMCIVREE delivered early, significant, and sustained weight reduction1-3
BMI Z-score* reduction in patients 6 to <18 years of age1-3†
In patients 6 to <18 years of age with BBS
IMCIVREE significantly reduced weight1
Weight changes in pivotal and supplemental patients 6 to <18 years of age with BBS during the 14-week double‑blind, placebo-controlled period*
*Results in sub-population based on post-hoc analysis. Supplemental patients were enrolled after the pivotal cohort had begun treatment. None of the supplemental patients had completed 52 weeks of IMCIVREE treatment at the time of data analysis.1
PCPB=placebo-controlled period baseline.
Reference: 1. Haqq AM et al. Lancet Diabetes Endocrinol. 2022;10(12):859-868. doi:10.1016/S2213-8587(22)00277-7. Supplemental appendix available at: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00277-7/fulltext.
Clinically significant -0.8 mean change in BMI Z-score at week 523,4
- Sustained mean reductions in BMI Z-score at 24 months in a long-term extension study5
*BMI Z-score was an exploratory endpoint used to measure the reduction in BMI in children. A BMI Z-score is a reliable measure of weight in children who are still growing because it accounts for height, age, and gender.6,7
†Data shown include only patients who received 52 weeks of IMCIVREE at the time of the analysis. Population sizes ranged from 8 to 16, with n=14 at 52 weeks on active treatment. Error bars are the standard deviation.2
‡A clinically significant reduction is generally considered a ≥0.2 reduction in BMI Z-score. A 0.2 reduction is comparable to weight loss of approximately 5%.3
§ATB=active treatment baseline, defined as the last measurement before the first dose of IMCIVREE; ie, week 0 for IMCIVREE group and week 14 for placebo group.2
Change in BMI Z-score from baseline in patients 6 to <18 years of age after 52 weeks (n=14)1
86%
of patients achieved a clinically significant ≥0.2 reduction* in BMI Z-score1,3
- 100% of patients <12 years of age achieved a clinically significant ≥0.2 reduction in BMI Z-score (n=3)1,3
In patients 6 to <18 years of age with BBS
IMCIVREE significantly reduced weight1
Weight changes in pivotal and supplemental patients 6 to <18 years of age with BBS during the 14-week double‑blind, placebo-controlled period*
*Results in sub-population based on post-hoc analysis. Supplemental patients were enrolled after the pivotal cohort had begun treatment. None of the supplemental patients had completed 52 weeks of IMCIVREE treatment at the time of data analysis.1
PCPB=placebo-controlled period baseline.
Reference: 1. Haqq AM et al. Lancet Diabetes Endocrinol. 2022;10(12):859-868. doi:10.1016/S2213-8587(22)00277-7. Supplemental appendix available at: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00277-7/fulltext.
*BMI Z-score was an exploratory endpoint used to measure the reduction in BMI in children. A clinically significant reduction is generally considered a ≥0.2 reduction in BMI Z-score. A 0.2 reduction is comparable to weight loss of approximately 5%.3
Patients were not required to change their diet or exercise routine1
Figure modeled after Gulati AK, Kaplan DW, Daniels SR. Clinical tracking of severely obese children: a new growth chart. Pediatrics. 2012;130(6):1136-1140.
*Growth chart is based on females 2 to 20 years of age and is for illustrative purposes only.
References: 1. Data on file. Rhythm Pharmaceuticals, Inc. Boston, MA. 2. Haqq AM et al. Lancet Diabetes Endocrinol. 2022;10(12):859-868. doi:10.1016/S2213-8587(22)00277-7. Supplemental appendix available at: https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00277-7/fulltext. 3. Grossman DC et al; US Preventive Services Task Force. JAMA. 2017;317(23):2417-2426. 4. IMCIVREE [prescribing information]. Boston, MA. Rhythm Pharmaceuticals, Inc. 5. Argente J et al. Endocrine Society Annual Meeting. Poster ODP606. June 11-14, 2022. 6. Vanderwall C et al. BMC Pediatrics. 2018;18(1):187. 7. Defining child BMI categories. Centers for Disease Control and Prevention. Accessed August 11, 2023. https://www.cdc.gov/obesity/basics/childhood-defining.html. 8. Centers for Disease Control and Prevention. 2000 CDC Growth Charts for the United States: Methods and Development. Accessed August 11, 2023. https://www.cdc.gov/nchs/data/series/sr_11/sr11_246.pdf. 9. Kelly AS et al. Circulation. 2013;128(15):1689-1712. 10. Gulati AK et al. Pediatrics. 2012;130(6):1136-1140. 11. Racette SB et al. BMC Pediatr. 2017;17(1):130. 12. Argente J et al. The Pediatric Endocrine Society Annual Meeting. Poster 155. April 28-May 1, 2022.
