Table 2.

Summary of C _trough and AUC data from pharmacokinetic analyses in the SparkThera (follicular lymphoma), SABRINA (non-Hodgkin lymphoma), and SAWYER (chronic lymphocytic leukemia) studies [44, 45, 47, 48]

C trough data
Study (rituximab dose) [dosing frequency/sampling time]	Rituximab C trough (μg/ml) Geometric mean [95% CI]		Geometric mean ratio C trough(SC)/C trough(IV) [90% CI]
	SC	IV
SparkThera (all SC doses; 375 mg/m2 IV) [q2 m/maintenance cycle 2]	32.2a [28.0–37.1]	25.9a [21.5–31.3]	1.24 [1.02–1.51]
SparkThera (all SC doses; 375 mg/m2 IV) [q3 m/maintenance cycle 2]	12.1a [10.1– 14.6]	10.9a [8.4– 14.1]	1.12 [0.86–1.45]
SABRINA (1400 mg SC; 375 mg/m2 IV) [q3w/induction cycle 7]
Stage 1	134.6 [43.2%b]	83.1 [36.7%b]	1.62c [1.36–1.94]
Stage 2	−	−	1.5 [1.3–1.7]
Pooled	121	78	1.5 [1.4–1.7]
SAWYER (1600 mg SC; 500 mg/m2 IV) [q4w/induction cycle 5]	97.5	61.5	1.53 [1.27–1.85]

AUC data
Study (rituximab dose) [dosing frequency/sampling time]	Rituximab AUC, μg·day/ml Geometric mean [95% CI]		Geometric mean ratio AUC(SC)/AUC(IV) [90% CI]
	SC	IV
SparkThera (all SC doses; 375 mg/m2 IV) [q2 m/maintenance cycle 2]	5430a [4980–5921]	4012a [3721–4326]	1.35d [1.23–1.49]
SparkThera (all SC doses; 375 mg/m2 IV) [q3 m/maintenance cycle 2]	5320a [4880–5799]	3947a [3662–4255]	1.35d [1.23–1.48]
SABRINA (1400 mg SC; 375 mg/m2 IV) [q3w/induction cycle 7]	3779	2734	1.38c [1.24–1.53]
SAWYER (1600 mg SC; 500 mg/m2 IV) [q4w/induction cycle 6]	4089	3630	1.10 [0.98–1.24]

AUC area under the concentration-time curve, CI confidence intervals, C _trough trough serum concentration, IV intravenous, q2 m every 2 months, q3 m every 3 months, q3w every 3 weeks, q4w every 4 weeks, SC subcutaneous

^aPredicted

^bCoefficient of variation

^cGeometric mean ratio adjusted for tumor load at baseline

^dAUC over the dosing interval tau