Population Pharmacokinetics of Daclizumab High-Yield Process in Healthy Volunteers and Subjects with Multiple Sclerosis: Analysis of Phase I–III Clinical Trials

Clinical Pharmacokinetics

Volumn 55, Issue 8, 2016, Pages 943-955

  Diao, Lei ^a,d   Hang, Yaming ^a   Othman, Ahmed A ^b,c   Nestorov, Ivan ^a   Tran, Jonathan Q ^a,e  

^a BIOGEN   (United States)

^b ABBVIE INC   (United States)

^c CAIRO UNIVERSITY   (Egypt)

^d Janssen China R D   (China)

^e CELGENE CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DACLIZUMAB; INTERLEUKIN 2 RECEPTOR ALPHA; NEUTRALIZING ANTIBODY; IL2RA PROTEIN, HUMAN; IMMUNOGLOBULIN G; IMMUNOSUPPRESSIVE AGENT; INTERLEUKIN 2 RECEPTOR; MONOCLONAL ANTIBODY;

ABSORPTION LAG TIME; ABSORPTION RATE CONSTANT; ADULT; AGED; ARTICLE; BODY WEIGHT; CENTRAL VOLUME OF DISTRIBUTION; COMPARTMENT MODEL; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG EFFECT; ELIMINATION RATE CONSTANT; FEMALE; HALF LIFE TIME; HUMAN; IMMUNOGENICITY; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MEAN ABSORPTION TIME; MULTIPLE SCLEROSIS; PERIPHERAL VOLUME OF DISTRIBUTION; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SINGLE DRUG DOSE; ADOLESCENT; BIOAVAILABILITY; BIOLOGICAL MODEL; BLOOD; CLINICAL TRIAL; DOSE RESPONSE; DRUG EFFECTS; INTRAVENOUS DRUG ADMINISTRATION; METABOLISM; MIDDLE AGED; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PROCEDURES; RANDOMIZED CONTROLLED TRIAL; YOUNG ADULT;

ADMINISTRATION, INTRAVENOUS; ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; BIOLOGICAL AVAILABILITY; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HEALTHY VOLUNTEERS; HUMANS; IMMUNOGLOBULIN G; IMMUNOSUPPRESSIVE AGENTS; INTERLEUKIN-2 RECEPTOR ALPHA SUBUNIT; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; RECEPTORS, INTERLEUKIN-2; YOUNG ADULT;

EID: 84957953613     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/s40262-016-0366-7     Document Type: Article

References (17)

1. National Multiple Sclerosis Society. Multiple sclerosis: just the facts general information. 2013. http://www.nationalmssociety.org/What-is-MS/Who-Gets-MS. Accessed 15 May 2015.
2. Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N Engl J Med. 2000;343(13):938–52. doi:10.1056/NEJM200009283431307.
3. Malek TR. The biology of interleukin-2. Annu Rev Immunol. 2008;26:453–79. doi:10.1146/annurev.immunol.26.021607.090357.
4. Waldmann T, Tagaya Y, Bamford R. Interleukin-2, interleukin-15, and their receptors. Int Rev Immunol. 1998;16(3–4):205–26. doi:10.3109/08830189809042995.
5. Pfender N, Martin R. Daclizumab (anti-CD25) in multiple sclerosis. Exp Neurol. 2014;262 Pt A:44–51. doi:10.1016/j.expneurol.2014.04.015.
6. Oh J, Calabresi PA. Emerging injectable therapies for multiple sclerosis. Lancet Neurol. 2013;12(11):1115–26. doi:10.1016/S1474-4422(13)70192-3.
7. Vincenti F, Kirkman R, Light S, Bumgardner G, Pescovitz M, Halloran P, et al. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. Daclizumab Triple Therapy Study Group. N Engl J Med. 1998;338(3):161–5. doi:10.1056/NEJM199801153380304.
8. Iwanowski P, Losy J. Immunological differences between classical phenothypes of multiple sclerosis. J Neurol Sci. 2015;349(1–2):10–4. doi:10.1016/j.jns.2014.12.035.
9. Gold R, Giovannoni G, Selmaj K, Havrdova E, Montalban X, Radue EW, et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet. 2013;381(9884):2167–75. doi:10.1016/S0140-6736(12):62190-4.
10. Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, et al. Daclizumab HYP versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2015;373(15):1418–28. doi:10.1056/NEJMoa1501481.
11. Othman AA, Tran JQ, Tang MT, Dutta S. Population pharmacokinetics of daclizumab high-yield process in healthy volunteers: integrated analysis of intravenous and subcutaneous, single- and multiple-dose administration. Clin Pharmacokinet. 2014;53(10):907–18. doi:10.1007/s40262-014-0159-9.
12. Giovannoni G, Gold R, Selmaj K, Havrdova E, Montalban X, Radue EW, et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial. Lancet Neurol. 2014;13(5):472–81. doi:10.1016/S1474-4422(14)70039-0.
13. Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN)—a Perl module for NONMEM related programming. Comput Methods Programs Biomed. 2004;75(2):85–94. doi:10.1016/j.cmpb.2003.11.003.
14. Minocha M, Tran JQ, Sheridan JP, Othman AA. Blockade of the high-affinity interleukin-2 receptors with daclizumab high-yield process: pharmacokinetic/pharmacodynamic analysis of single- and multiple-dose phase I trials. Clin Pharmacokinet. 2016;55(1):121–30. doi:10.1007/s40262-015-0305-z.
15. Giovannoni G, Mikulskis A, McNeil M, Riester K, Sweetser M, Elkins J, et al. Evaluation of immunogenicity in multiple sclerosis patients continuously treated with daclizumab-HYP during the SELECT and SELECTION clinical trials. Mult Scler J. 2013;19(11):390 [abstract poster (P864)].
16. Amaravadi L, Mikulskis A, Lucas N, Riester K, Sweetser M, Elkins J. Evaluation of immunogenicity in patients with multiple sclerosis treated with daclizumab HYP [poster]. 67th Annual Meeting of the American Academy of Neurology; 18–25 Apr 2015; Washington, DC.
17. Anonymous. DAC HYP BLA 2.7.2 Summary of Clinical Pharmacology. Biogen, 2015 (Data on file).