Long-term treatment adherence to the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab in 6 ODYSSEY Phase III clinical studies with treatment.

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Long-term treatment adherence to the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab in 6 ODYSSEY Phase III clinical studies with treatment duration of 1 to 2 years Michel Farnier, MD, PhD, Helen M. Colhoun, MD, MFPHM, FRCP(Ed), William J. Sasiela, PhD, Jay M. Edelberg, MD, PhD, Gaëlle Asset, MSc, Jennifer G. Robinson, MD, MPH Journal of Clinical Lipidology Volume 11, Issue 4, Pages 986-997 (July 2017) DOI: 10.1016/j.jacl.2017.05.016 Copyright © 2017 National Lipid Association Terms and Conditions

Figure 1 ODYSSEY Phase III studies and patient populations included in this analysis (randomized and treated population). Clinicaltrials.gov identifiers: NCT01507831 (LONG TERM); NCT01617655 (HIGH FH); NCT01623115 (FH I); NCT01709500 (FH II); NCT01644175 (COMBO I); NCT01644188 (COMBO II). †Alirocumab dose could be increased from 75 mg Q2W to 150 mg Q2W at Week 12 depending on Week 8 LDL-C level. n: randomized and treated patients. CV, cardiovascular; FH, familial hypercholesterolemia; HeFH, heterozygous familial hypercholesterolemia; LDL-C, low-density lipoprotein cholesterol; LLT, lipid-lowering therapy; Q2W, every 2 weeks. Journal of Clinical Lipidology 2017 11, 986-997DOI: (10.1016/j.jacl.2017.05.016) Copyright © 2017 National Lipid Association Terms and Conditions

Figure 2 Mean (SD) overall treatment adherence† (to alirocumab or placebo injections) in individual studies (randomized and treated population). Clinicaltrials.gov identifiers: NCT01507831 (LONG TERM); NCT01617655 (HIGH FH); NCT01623115 (FH I); NCT01709500 (FH II); NCT01644175 (COMBO I); NCT01644188 (COMBO II). †Overall treatment adherence was calculated as 100 − (percentage of days with below-planned dosing + percentage of days with above-planned dosing). SD, standard deviation. Journal of Clinical Lipidology 2017 11, 986-997DOI: (10.1016/j.jacl.2017.05.016) Copyright © 2017 National Lipid Association Terms and Conditions

Figure 3 Alirocumab-induced percentage change in LDL-C from baseline to Week 52 according to treatment adherence category and starting dose regimen (modified ITT population). Pooled data from patients treated in the alirocumab arm of 6 phase III ODYSSEY trials (FH I, FH II, HIGH FH, COMBO I, COMBO II, and LONG TERM) are shown. Patients received alirocumab 150 mg Q2W in LONG TERM and HIGH FH studies, whereas patients in the remaining studies received an initial alirocumab dose of 75 mg Q2W with the possibility of dose increase to 150 mg Q2W at week 12 based on LDL-C at Week 8. Boxplots were based on calculated LDL-C values during the on-treatment period (modified ITT population). Missing data at Week 52 imputed using last value on-treatment. The central line within a given box represents the median, and the mean is denoted by the diamond. The lower and upper boundaries of the box represent the lower (Q1) and upper (Q3) quartiles. The ends of the “whiskers” signify Q1 − 1.5 interquartile range and Q3 + 1.5 interquartile range. The small circles above each box denote the outliers (>Q3 + 1.5 interquartile range). †Patients received an initial dose of 75 mg Q2W alirocumab, which was increased in an automated manner to 150 mg Q2W at Week 12 depending on LDL-C levels at Week 8. N: number of patients with adherence nonmissing and at least 1 nonmissing LDL-C value during the on-treatment period. ITT, intent-to-treat; LDL-C, low-density lipoprotein cholesterol; Q2W, every 2 weeks; SD, standard deviation. Journal of Clinical Lipidology 2017 11, 986-997DOI: (10.1016/j.jacl.2017.05.016) Copyright © 2017 National Lipid Association Terms and Conditions