Intravenous tocilizumab for the treatment of giant cell arteritis: a phase Ib dose-ranging pharmacokinetic bridging study

Table 5 Summary of pharmacokinetic steady-state TCZ exposure parameters

Studies	Dosing regimen	Patient population	Number	AUC_τ (day•μg/mL)	C_mean (μg/mL)	C_max (μg/mL)	C_trough (μg/mL)
Present study^a	6 mg/kg IV Q4W	GCA	22	1610 (921–3070)	57.5 (32.9–110)	178 (115–320)	22.7 (3.38–54.5)
Present study^a	7 mg/kg IV Q4W	GCA	22	2130 (1120–4300)	76.0 (40.1–154)	197 (118–352)	37.2 (6.59–69.0)
Phase II IIS (NCT01450137) [10]^b	8 mg/kg IV Q4W	GCA	20	2249 (457–5778)	80.3 (16–206)	190 (48.5–538)	35.5 (0–145)
GiACTA (NCT01791153) [9]^b	162 mg SC QW	GCA	100	495 (82–1042)	70.6 (11.7–149)	72.1 (12.2–151)	67.2 (10.7–145)
GiACTA (NCT01791153) [9]^b	162 mg SC Q2W	GCA	49	191 (97.7–686)	13.7 (0.5–49)	17.2 (1.1–56.2)	7.7 (0.1–37.3)
PopPK RA^c	8 mg/kg IV Q4W	RA	2155	1512 (476–7283)	54.0 (17.0–260)	176 (75.4–557)	13.4 (0.1–154)

Values are median (range)
AUC_τ Area under the curve over a dosing interval (τ), C_max Maximum concentration, C_mean Mean concentration (AUC_τ/τ), C_trough Minimum (trough) concentration, GCA Giant cell arteritis, IIS Investigator-initiated study, IV Intravenous, PopPK Population PK, PK Pharmacokinetic, QW Every week, Q2W Every 2 weeks, Q4W Every 4 weeks, RA Rheumatoid arthritis, SC Subcutaneous, TCZ Tocilizumab
^aNoncompartmental analysis
^bPopPK analysis
^cPopPK analysis of RA studies WA17822 (NCT00106548), WA17824 (NCT00109408), WA18062 (NCT00106522), WA18063 (NCT00106574), and WA22762 and NA25220 (NCT01662063) (data on file)

ISSN: 1478-6362