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Abstract Number: 2416

Pharmacokinetics, Safety, and Tolerability of Tofacitinib in Pediatric Patients from Six to Less Than Eighteen Years of Age with Juvenile Idiopathic Arthritis

Hermine I. Brunner1, Nicolino Ruperto2, Nikolay Tzaribachev3, Zbigniew Zuber4, Elena Koskova5, Ivan Foeldvari6, Eizbieta Smolewska7, Gerd Horneff8, Charles Mebus9, Umberto Conte10, Rong Wang9, Christine Alvey9, Manisha Lamba9, Anasuya Hazra11, Daniel Lovell12 and Alberto Martini13, 1Pediatric Rheumatology Collaborative Study Group, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 2Istituto G. Gaslini, Pediatria II, PRINTO, Genoa, Italy, 3Pediatric Rheumatology, Bad Bramstedt, Germany, 4St Louis Children’s Hospital ODS Rheumatology and Neurology, Krakow, Poland, 5Institute of Rheumatic Diseases, Piestany, Slovakia, 6Hamburger Zentrum für Kinder-und Jugendrheumatologie, Hamburg, Germany, 7Department of Pediatric Cardiology and Rheumatology, Medical University of Lodz, Lodz, Poland, 8Asklepios Klinik Sankt Augustin GmbH, Sankt Augustin, Germany, 9Pfizer Inc, Groton, CT, 10Pfizer Inc, New York, NY, 11Pfizer Inc, Collegeville, PA, 12Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 13Istituto G. Gaslini, Pediatria II, PRINTO, and University of Genoa, Genoa, Italy

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: juvenile idiopathic arthritis (JIA), pediatrics, pharmacokinetics, safety and tofacitinib

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Session Information

Date: Tuesday, November 10, 2015

Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects Posters (ACR): Imaging and Novel Clinical Interventions

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Tofacitinib
is an oral Janus kinase inhibitor for the treatment of adult patients with rheumatoid
arthritis (RA). We report the pharmacokinetics (PK), safety and taste
acceptability of tofacitinib following multiple oral doses in children 6 to
<18 years of age with active juvenile idiopathic arthritis (JIA).

Methods: Data were
obtained from an ongoing open-label, non-randomized,
multi-center, Phase I study (NCT01513902) where children with JIA were given 5 mg adult
equivalent (based on body weight) of tofacitinib (tablet or solution) twice
daily (BID) for 5 days. There were 3 cohorts (COH) based on subject
age, COH 1: 12 to <18 years, COH 2: 6 to <12 years,
and COH 3: 2 to <6 years, with a target enrollment per group of at
least 8 children with JIA for a total number of at least 24 evaluable
subjects completing the PK period. Patients were enrolled in a step-wise
approach beginning with the older age cohort first. Subsequent younger age cohorts
were enrolled following confirmation of safety and PK from the previous
cohorts. PK parameters of tofacitinib were calculated using non-compartmental
analysis of plasma concentration (conc)-time data.

Results: Results from the
first 16 subjects from COH 1 and COH 2 were
included in this analysis. Overall, subjects’ age ranged from 8 to 17 years;
all were white race except for one. There were 5 females and 3 males in
COH 1 and in COH 2. Baseline disease characteristics were similar
across both COH, except CRP; where the mean value was slightly higher in COH 2
than COH 1 (5.7 versus 3.8 mg/L). All exposure metrics including area under the conc-time curves
(AUCtau), maximum (Cmax), minimum (Cmin),
predose (Ctrough) conc were lower in COH 2 relative to those in
COH 1. Apparent volume of distribution (Vz/F) was approximately
32% lower in COH 2 (71 L) relative to COH 1 (104.9 L). Average terminal
half-life (t½) was 25.5% shorter in the younger patients (1.949 hours
in COH 2, to 2.616 hours in COH 1). Mean CL/F of tofacitinib in children
with JIA in this study were 52.7% and 38.4% higher in COH 1 and COH 2 subjects,
respectively, compared with adult patients with RA receiving tofacitinib 5 mg
BID equivalent (based on allometry) dose of tofacitinib (18.4 L/h). PK parameters were similar between males and females. Tofacitinib, administered over 5 days as
multiple dose tablets or solution formulation, was well tolerated and taste was
found acceptable in children with active JIA. No serious adverse events or new
safety signals were identified.

Conclusion:
PK
results from this study established dosing regimens for children aged 6 years
and older to be used in the upcoming efficacy and safety studies of tofacitinib
in patients with JIA. Tofacitinib was well tolerated in this study in children
with JIA. Overall, subjects found the taste of the tofacitinib solution
formulation to be acceptable.

 

 


Disclosure: H. I. Brunner, Novartis, Roche, Pfizer, UCB, Celgene, Regeneron, Amgen, AstraZeneca, and GlaxoSmithKline,, 2,Novartis and Roche, 8; N. Ruperto, Abbott, AbbVie, Amgen, Biogen Idec, Astellas Pharma, Alter, AstraZeneca, Boehringer, Bristol Meyers Squibb, CD-Pharma, Celgene, Crescendo Bioscience, EMD Serono, Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, San, 5,Abbott, AbbVie, Amgen, Biogen Idec, Astellas Pharma, Alter, AstraZeneca, Boehringer, Bristol Meyers Squibb, CD-Pharma, Celgene, Crescendo Bioscience, EMD Serono, Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, San, 8; N. Tzaribachev, Pfizer, UCB and Roche, 2; Z. Zuber, None; E. Koskova, None; I. Foeldvari, None; E. Smolewska, None; G. Horneff, Abbvie, Chuigai, Pfizer and Roche, 2; C. Mebus, Pfizer Inc, 1,Pfizer Inc, 3; U. Conte, Pfizer Inc, 1,Pfizer Inc, 3; R. Wang, Pfizer Inc, 1,Pfizer Inc, 3; C. Alvey, Pfizer Inc, 1,Pfizer Inc, 3; M. Lamba, Pfizer Inc, 1,Pfizer Inc, 3; A. Hazra, Pfizer Inc, 1,Pfizer Inc, 3; D. Lovell, AstraZeneca, Bristol Meyers Squibb, AbbVie, Pfizer, Roche, Novartis, UBC, Forest Research Institute, Horizon, Johnson & Johnson, Biogen, Takeda, Genentech, GlaxoSmithKline, Boehringer Ingelheim, Celgene, and Janssen, 5,Genentech, Roche, and Novartis, 8; A. Martini, None.

To cite this abstract in AMA style:

Brunner HI, Ruperto N, Tzaribachev N, Zuber Z, Koskova E, Foeldvari I, Smolewska E, Horneff G, Mebus C, Conte U, Wang R, Alvey C, Lamba M, Hazra A, Lovell D, Martini A. Pharmacokinetics, Safety, and Tolerability of Tofacitinib in Pediatric Patients from Six to Less Than Eighteen Years of Age with Juvenile Idiopathic Arthritis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/pharmacokinetics-safety-and-tolerability-of-tofacitinib-in-pediatric-patients-from-six-to-less-than-eighteen-years-of-age-with-juvenile-idiopathic-arthritis/. Accessed .
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