Impaired Kidney Function Associated with Increased Risk of Side Effects in Patients with Small Vessel Vasculitis Treated with Rituximab as an Induction Therapy
Abstract
:1. Introduction
2. Methods
- complete remission: 0 points in the BVAS/WG score after 6 months;
- partial remission: drop by 50% in the BVAS/WG score after 6 months;
- inadequate response: <50% reduction of disease activity in the BVAS/WG score after 6 months.
Statistical Analysis
3. Results
3.1. Efficacy
3.2. Safety
4. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Parameter | RTX Induction n = 20 | |
---|---|---|
Age (years) | mean ± SD min–max | 49 ± 13 24–70 |
Sex: | ||
Male | n (%) | 10 (50%) |
Female | n (%) | 10 (50%) |
ANCA type: | ||
PR3-ANCA | n (%) | 18 (90%) |
MPO-ANCA | n (%) | 1 (5%) |
ANCA negative | n (%) | 1 (5%) |
Duration of SVV (years) | median (IQR) min–max | 3 (1–5.5) 0–19 |
Treatment of SVV | ||
Indication for RTX induction: | ||
—Failure of CYC | n (%) | 8 (40%) |
—High cumulative dose of CYC | n (%) | 11 (55%) |
—Adverse effects related to CYC | n (%) | 1 (5%) |
CYC cumulative dose (g) | median (IQR) min–max | 11 (7.5–23) 0.7–60 |
CYC cumulative dose: | ||
>36 g | n (%) | 3 (15%) |
≤36 g | n (%) | 17 (85%) |
CYC cumulative dose (mg/kg) | median (IQR) min–max | 152 (96–303) 13–759 |
CYC cumulative dose: | ||
>120 mg/kg | n (%) | 13 (65%) |
≤120 mg/kg | n (%) | 7 (35%) |
Parameter | RTX Induction n = 20 | |
---|---|---|
Clinical picture of SVV | ||
Renal involvement: | ||
—no 1 | n (%) | 3 (15%) |
—yes, CKD G1-G3 | n (%) | 8 (40%) |
—yes, CKD G4-G5D 2 | n (%) | 9 (45%) |
Disease activity by BVAS/WG: | ||
—general symptoms | n (%) | 9 (45%) |
—cutaneous | n (%) | 5 (25%) |
—mucosal membranes/eyes | n (%) | 1 (5%) |
—ear–nose–throat (ENT) | n (%) | 15 (75%) |
—cardiovascular | n (%) | 0 |
—gastrointestinal | n (%) | 1 (5%) |
—pulmonary | n (%) | 15 (75%) |
—renal | n (%) | 12 (60%) |
—nervous system | n (%) | 4 (20%) |
—other | n (%) | 8 (40%) |
SVV course: | ||
—limited flare | n (%) | 5 (25%) |
—severe flare | n (%) | 10 (50%) |
—severe multiorgan flare | n (%) | 5 (25%) |
Dominant organ activity (presence of major symptoms): | ||
—eye | ||
—ENT | n (%) | 1 (5%) |
—pulmonary | n (%) | 4 (20%) |
—gastrointestinal | n (%) | 2 (10%) |
—renal | n (%) | 1 (5%) |
—nervous system | n (%) | 4 (20%) |
—other | n (%) | 3 (15%) |
Dominant organ activity (presence of major symptoms): | n (%) | 4 (20%) * |
Parameter | Baseline | Month 6 | p-Value | |
---|---|---|---|---|
BVAS/WG score | median (IQR) min–max | 6 (5–9) 3–12 | 0 (0–0) 0–4 | 0.0001 * |
ANCA titre (IU/mL) | median (IQR) min–max | 30 (10–124) 0–177 | 6.2 (0–24) 0–174 | 0.0003 * |
IgA (mg/dL) | mean ± SD min–max | 196.5 ± 66.7 109–330 | 141.9 ± 53.2 58–247 | 0.0001 |
IgM (mg/dL) | median (IQR) min–max | 65 (34–117) 26–164 | 39.5 (28–65) 10–127 | 0.0003 * |
IgG (mg/dL) | mean ± SD min–max | 969.5 ± 320.7 369–1740 | 726.3 ± 243.3 325–1230 | 0.002 |
IgG (mg/dL) <400 400–699 ≥700 | n (%) n (%) n (%) | 1 (5%) 3 (15%) 16 (80%) | 1 (5%) 9 (45%) 10 (50%) | 0.112 # |
Serum creatinine (mg/dL) | median (IQR) min–max | 1.6 (0.9–2.5) 0.8–4.5 | 1.4 (1.0–2.1) 0.8–5.7 | 1.000 |
eGFR ^ (mL/min/1.73 m2) | median (IQR) min–max | 54 (25–79) 15–108 | 55 (29–75) 11–90 | 0.691 * |
Hematuria ^ | 0.039 | |||
—yes, massive | n (%) | 5 (31.25%) | 0 | |
—yes, non-massive | n (%) | 5 (31.25%) | 5 (31.25%) | |
—no | n (%) | 6 (37.5%) | 11 (68.75%) | |
Proteinuria (mg/dL) | median (IQR) | 29 (10–46) | 21 (10–43) | 0.722 |
Parameter | No Adverse Events n = 12 | Adverse Events n = 8 | p-Value | |
---|---|---|---|---|
Age (years) | mean ± SD | 42 ± 11 | 57 ± 12 | 0.014 * |
Sex: Male Female | n (%) n (%) | 5 (41.7%) 7 (58.3%) | 5 (62.5%) 3 (37.5%) | 0.650 |
Duration of AAV (years) | median (IQR) | 3 (3–10.5) | 1.5 (1–4) | 0.107 |
CYC cumulative dose (g) | median (IQR) | 18 (9.63–35.5) | 8.75 (6.5–10.38) | 0.082 |
CYC cumulative dose: >36 g ≤36 g | n (%) n (%) | 3 (25%) 9 (75%) | 0 8 (100%) | 0.242 |
CYC cumulative dose (mg/kg) | median (IQR) | 185 (133–465) | 105 (82–209) | 0.153 |
CYC cumulative dose: >120 mg/kg ≤120 mg/kg | n (%) n (%) | 10 (83.3%) 16.7%) | 3 (37.5%) 5 (62.5%) | 0.062 |
RTX single dose (mg) | mean ± SD | 721 ± 96 | 700 ± 122 | 0.682 |
Baseline BVAS/WG score | median (IQR) | 5 (4.5–8) | 6 (6–10) | 0.111 |
Baseline ANCA titre (IU/mL) | median (IQR) | 37 (4–127) | 26 (8–73) | 0.847 |
Serum creatinine (mg/dL) | median (IQR) | 1.3 (0.85–2.05) | 3.35 (2.2–4.9) | 0.044 |
eGFR (mL/min/1.73 m2) G1-G3: ≥30 G4-G5D: <30 | n (%) n (%) | 9 (75%) 3 (25%) | 2 (25%) 6 (75%) | 0.040 # |
eGFR (mL/min/1.73 m2) | mean ± SD | 57 ± 32 | 29 ± 26 | 0.049 |
IgA (mg/dL) | mean ± SD | 207.2 ± 65.5 | 175.9 ± 71.4 | 0.337 * |
IgM (mg/dL) | median (IQR) | 67 (53.5–128.5) | 52.5 (31.5–85) | 0.203 |
IgG (mg/dL) | mean ± SD | 995.7 ± 317.3 | 921.9 ± 345.8 | 0.636 * |
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Rymarz, A.; Matyjek, A.; Sułek-Jakóbczyk, M.; Mosakowska, M.; Niemczyk, S. Impaired Kidney Function Associated with Increased Risk of Side Effects in Patients with Small Vessel Vasculitis Treated with Rituximab as an Induction Therapy. J. Clin. Med. 2021, 10, 786. https://doi.org/10.3390/jcm10040786
Rymarz A, Matyjek A, Sułek-Jakóbczyk M, Mosakowska M, Niemczyk S. Impaired Kidney Function Associated with Increased Risk of Side Effects in Patients with Small Vessel Vasculitis Treated with Rituximab as an Induction Therapy. Journal of Clinical Medicine. 2021; 10(4):786. https://doi.org/10.3390/jcm10040786
Chicago/Turabian StyleRymarz, Aleksandra, Anna Matyjek, Magdalena Sułek-Jakóbczyk, Magdalena Mosakowska, and Stanisław Niemczyk. 2021. "Impaired Kidney Function Associated with Increased Risk of Side Effects in Patients with Small Vessel Vasculitis Treated with Rituximab as an Induction Therapy" Journal of Clinical Medicine 10, no. 4: 786. https://doi.org/10.3390/jcm10040786