The pharmacokinetic effect of coadministration of apremilast and methotrexate in individuals with rheumatoid arthritis and psoriatic arthritis

Clinical Pharmacology in Drug Development

Volumn 3, Issue 6, 2014, Pages 456-465

  Liu, Yong ^a   Zhou, Simon ^a   Nissel, James ^a   Wu, Anfan ^a   Lau, Henry ^a   Palmisano, Maria ^a  

^a CELGENE CORPORATION   (United States)

Author keywords

Drug interaction; Inflammatory autoimmune disorders; Phosphodiesterase 4 inhibitor

Indexed keywords

APREMILAST; METHOTREXATE;

ABDOMINAL PAIN; ADULT; ANXIETY; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DIARRHEA; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG INDICATION; DRUG SAFETY; DYSGEUSIA; DYSPEPSIA; FEMALE; HEADACHE; HUMAN; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PAIN; PLASMA CLEARANCE; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; PSORIATIC ARTHRITIS; RHEUMATOID ARTHRITIS; SKIN ABSCESS; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; VOLUME OF DISTRIBUTION AT STEADY-STATE;

EID: 84916598800     PISSN: 2160763X     EISSN: 21607648     Source Type: Journal    
DOI: 10.1002/cpdd.109     Document Type: Article

References (20)

1. Shutty B, West C, Pellerin M, Feldman S. Apremilast as a treatment for psoriasis. Expert Opin Pharmacother. 2012; 13:1761-1770.
2. Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol. 2012; 83:1583-1590.
3. Hoffmann M, Kumar G, Schafer P, et al. Disposition, metabolism and mass balance of [14C]apremilast following oral administration. Xenobiotica. 2011; 41:1063-1075.
4. 14C] labeled microtracer IV solution concomitantly with an oral dose [abstract]. 2011 AAPS Annual Meeting and Exposition; October 23-27, 2011; Washington, DC.
5. Weinblatt ME. Methotrexate in rheumatoid arthritis: a quarter century of development. Trans Am Clin Climatol Assoc. 2013; 124:16-25.
6. Seideman P, Beck O, Eksborg S, Wennberg M. The pharmacokinetics of MTX and its 7-hydroxy metabolite in patients with rheumatoid arthritis. Br J Clin Pharmacol. 1993; 35:409-412.
7. Tian H, Cronstein BN. Understanding the mechanisms of action of methotrexate-Implications for the treatment of rheumatoid arthritis. Bull NYU Hosp Jt Dis. 2007; 65:168-173.
8. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis: results of a phase 3, randomized, controlled trial [abstract L13]. Arthritis Rheum. 2012; 64:4172-4173.
9. Papp K, Cather J, Rosoph L, et al. The efficacy of apremilast, a phosphodiesterase-4 inhibitor, in the treatment of moderate to severe psoriasis: results of a phase 2 randomised study. Lancet. 2012; 380:738-746.
10. Reich K, Papp K, Leonardi C, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe psoriasis: 16-week results of a phase 3, randomized, controlled trial (ESTEEM 1) [oral presentation]. Annual Meeting of the American Academy of Dermatology; March 1-5, 2013; Miami, FL.
11. Schett G, Wollenhaupt J, Papp K, et al. Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2012; 64:3156-3167.
12. Wu A, Dvorchik B, Cahell C, et al. Double-blind, randomized, multiple-dose, crossover, fourtreatment, four-period, four sequence study to investigate the effects of apremilast on the QT interval in healthy male subjects abstract #152. J Clin Pharmacol. 2010; 50:1058-1095.
13. Murakami T, Yokooji T, Mori N. Study on absorption sites of quinidine and methotrexate in rat intestine. Pharmazie. 2010; 65:440-447.
14. Urquhart BL, Gregor JC, Chande N, Knauer MJ, Tirona RG, Kim RB. The human proton-coupled folate transporter (hPCFT): modulation of intestinal expression and function by drugs. Am J Physiol Gastrointest Liver Physiol. 2010; 298:G248-G254.
15. Bezabeh S, Mackey AC, Kluetz P, Jappar D, Korvick J. Accumulating evidence for a drug-drug interaction between methotrexate and proton pump inhibitors. Oncologist. 2012; 17:550-554.
16. Vakily M, Amer F, Kukulka MJ, Andhivarothai N. Coadministration of lansoprazole and naproxen does not affect the pharmacokinetic profile of methotrexate in adult patients with rheumatoid arthritis. J Clin Pharmacol. 2005; 45:1179-1186.
17. Vlaming ML, van Esch A, van de Steeg E, et al. Impact of Abcc2 [multidrug resistance-associated protein (Mrp) 2], Abcc3 (Mrp3), and Abcg2 (breast cancer resistance protein) on the oral pharmacokinetics of methotrexate and its main metabolite 7-hydroxymethotrexate. DMD. 2011; 39:1338-1344.
18. Nozaki Y, Kusuhara H, Kondo T, et al. Species difference in the inhibitory effect of nonsteroidal anti-inflammatory drugs on the uptake of methotrexate by human kidney slices. JPET. 2007; 322:1162-1170.
19. Takeda M, Khamdang S. Narikawa S et.al. Characterization of methotrexate transport and its drug interactions with human organic anion transporters. J Pharmacol Exp Ther. 2002; 2:666-671.
20. Breedveld P, Zelcer N, Pluim D, et al. Mechanism of the pharmacokinetic interaction between MTX and benzimidazoles: potential role of breast cancer resistance protein in clinical drug-drug interactions. Cancer Res. 2004; 64:5804-5811.