Article Figures & Data
Figures
- Figure 1.
A. Study design. *Randomization/retreatment from Week 24 for patients with DAS ≥ 2.6. **Primary endpoint: ACR20 from baseline at Week 48. B. Baseline patient and disease disposition. *Physician/patient decisions were for reasons other than adverse events. †90% (n = 426) retreated between Weeks 24 and 28. RTX: rituximab; MTX: methotrexate; DAS: Disease Activity Score; ACR: American College of Rheumatology; ITT: intent-to-treat.
- Figure 2.
A. Week 48 ACR 20/50/70 responses. B. EULAR scores (left) and DAS results (right). C. Mean change in DAS28 scores.
- Figure 3.
Week 48 results. A. ACR20/50/70 responders. B. ACR nonresponders. C. EULAR responders. D. EULAR nonresponders. DAS: Disease Activity Score.
- Figure 4.
Maintenance of ACR20 (A), ACR50 (B), and ACR70 (C) responses over time. Odds ratios represent odds of losing response if not retreated with active rituximab.
- Figure 5.
A. Mean changes in ACR core criteria in the ITT population from baseline to Week 48. Negative change indicates improvement. Last observation was carried forward to impute missing components. B. Changes over time in ACR core criteria. Pain is measured by visual analog scale. SJC: swollen joint count; TJC: tender joint count; PtGA/PhGA: patient/physician global assessment of disease activity; HAQ: Health Assessment Questionnaire; ESR: erythrocyte sedimentation rate; CRP: C-reactive protein; VAS: visual analog scale.
- Figure 6.
Median CD19+ absolute counts (cells/μl) at baseline and through Week 44 by retreatment group. Peripheral CD19 counts were not measured at Week 48. B*: baseline; P*: post-baseline; MTX: methotrexate.
- Figure 7.
Proportions of patients with infusion reactions during open-label and double-blind phases. One serious adverse event (hypotension) occurred during the first infusion of the first course and no serious adverse events in subsequent 3 infusions. Patients received preinfusion methylprednisolone 100 mg IV.
Tables
Characteristics Placebo Retreatment, n = 157 Rituximab Retreatment, n = 318 Mean age (SD), yrs 54 (11) 54 (11) Range 28–80 25–80 Female, n (%) 124 (79) 257 (81) Race, n (%) White 126 (80) 248 (78) Black 12 (8) 26 (8) Hispanic 15 (10) 30 (9) Other 4 (2) 9 (3) Disease characteristics Rheumatoid factor-positive, n (%)a 118 (75) 244 (77) Anti-CCP-positive, n (%)b 119 (78) 223 (74) Mean (IU/ml) for RF-positive patients 523 628 Mean (SD) RA duration, yrs 11 (8.5) 12 (9.2) Mean (SD) tender joint count (68–joint count) 33 (18.0) 32 (15.6) Mean (SD) swollen joint count (66–joint count) 22 (13.2) 22 (11.5) Mean (SD) DAS28 6.7 (1.0) 6.7 (1.0)* Mean (SD) C-reactive protein, mg/dl 2.2 (3.0) 1.9 (2.4) Mean erythrocyte sedimentation rate (SD), mm/h 44.6 (26.30) 42.4 (26.10)** Mean (SD) HAQ-DI 1.5 (0.6) 1.5 (0.6)** Mean (SD) MTX dose, mg/week 16.4 (4.6) 16.4 (4.6) Mean (SD) prednisone dose, mg/day 7.4 (2.62) 7.1 (3.00) Number (%) patients on steroids 79 (50.3) 164 (51.6) Prior use of TNF inhibitor(s), n (%) 1 previous TNF inhibitor 84 (53) 181 (57) 2 previous TNF inhibitors 55 (35) 101 (32) 3 previous TNF inhibitors 18 (12) 35 (11) Mean no. of previous DMARD (%) (excluding MTX, including TNF inhibitors) 4.1 (1.9) 4.1 (2.0) -
Anti-CCP: anti-cyclic citrullinated peptide; DAS28-ESR: Disease Activity Score 28 and erythrocyte sedimentation rate; DMARD: disease-modifying antirheumatic drug; MTX: methotrexate.
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↵a Rheumatoid factor positivity is defined as ≥ 15 IU/ml.
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↵b Anti-CCP positivity is defined as ≥ 20 units.
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↵* Five patients were not measured.
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↵** Three patients were not measured.
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- Table 2.
Proportion of patients (%) with immunoglobulin (Ig) levels below laboratory lower limit of normal (LLN) by retreatment group. Normal ranges for IgG, IgM, and IgA are 6.72–14.4, 0.57–2.85, and 0.59–3.96 mg/ml, respectively.
Percentage of Patients with Immunoglobulin < LLN Week 24 (prerandomization) Week 48 (primary endpoint) IgG Placebo retreatment 5 4 Rituximab retreatment 7 7 IgM Placebo retreatment 9 14 Rituximab retreatment 14 26 IgA Placebo retreatment 0 0 Rituximab retreatment 0.3 0.4 - Table 3.
Summary of safety events during randomized retreatment period. Data are number of patients (%).
Safety Events Retreatment with Placebo (n = 155) Retreatment with Rituximab (n = 320) Adverse events 119 (77) 226 (71) Serious adverse events 11 (7) 22 (7) Infections 59 (38) 120 (38) Serious infections 3 (2) 7 (2) Adverse events leading to withdrawal 7 (4) 7 (2) Deaths* 1 (0.6) 1 (0.3) -
↵* One additional death in rituximab retreatment group after the Week 48 cutoff date.
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- Table 4.
Serious infections† during randomized retreatment period. Data are number of patients (%).
Serious Infections Retreatment with Placebo (n = 155) Retreatment with Rituximab (n = 320) Total serious infections 3 (2) 7 (2) Pneumonia* 1 2 Abdominal wall abscess 1 0 Gastroenteritis 0 1 Perirectal abscess 0 1 Urosepsis 0 1 Pyelonephritis 1 0 Bursitis 0 1 Acute respiratory distress syndrome* 1 1
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