In RA studies, total serum immunoglobulin levels, IgM, IgG, and IgA were reduced at 6 months with the greatest change observed in IgM. However, mean immunoglobulin levels remained within normal levels over the 24-week period. Small proportions of patients experienced decreases in IgM (7%), IgG (2%), and IgA (1%) levels below the lower limit of normal. The clinical consequences of decreases in immunoglobulin levels in RA patients treated with Rituxan are unclear.

Treatment with Rituximab in patients with RA was associated with reduction of certain biologic markers of inflammation such as interleukin-6 (IL-6), C-reactive protein (CRP), serum amyloid protein (SAA), S100 A8/S100 A9 heterodimer complex (S100 A8/9), anti-citrullinated peptide (anti-CCP) and RF.

Clinical Studies

Relapsed or Refractory, Low-Grade or Follicular, CD-20 Positive, B-Cell NHL

Rituxan regimens tested include treatment weekly for 4 doses and treatment weekly for 8 doses. Results for studies with a collective enrollment of 296 patients are summarized below (Table 2):

Table 2
Summary of Rituxan Efficacy Data by Schedule and Clinical Setting
(See ADVERSE REACTIONS for Risk Factors Associated with Increased Rates of Adverse Events)

Weekly for 4 Doses

Study 1

A multicenter, open-label, single-arm study was conducted in 166 patients with relapsed or refractory, low-grade or follicular B-cell NHL who received 375 mg/m² of Rituxan given as an IV infusion weekly for 4 doses.¹⁴ Patients with tumor masses > 10 cm or with > 5000 lymphocytes/µ L in the peripheral blood were excluded from the study. Results are summarized in Table 2. The median time to onset of response was 50 days and the median duration of response was 11.2 months (range, 1.9-42.1+). Disease-related signs and symptoms (including B-symptoms) were present in 23% (39/166) of patients at study entry and resolved in 64% (25/39) of those patients.

In a multivariate analysis, the ORR was higher in patients with IWF B, C, and D histologic subtypes as compared to IWF subtype A (58% vs. 12%), higher in patients whose largest lesion was < 5 cm vs. > 7 cm (maximum, 21 cm) in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared with chemoresistant (defined as duration of response < 3 months) relapse (53% vs. 36%). ORR in patients previously treated with autologous bone marrow transplant was 78% (18/23). The following adverse prognostic factors were not associated with a lower response rate: age ≥ 60 years, extranodal disease, prior anthracycline therapy, and bone marrow involvement.

Weekly for 8 Doses

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