A 4-year observation in lupus nephritis patients treated with an intensified B-lymphocyte depletion without immunosuppressive maintenance treatment—Clinical response compared to literature and immunological re-assessment

Roccatello, Dario; Sciascia, Savino; Baldovino, Simone; Rossi, Daniela; Alpa, Mirella; Naretto, Carla; Simone, D. Di; Simoncini, Matteo; Menegatti, Elisa

doi:10.1016/j.autrev.2015.07.017

Cited by 56 publications

(47 citation statements)

References 41 publications

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“…Rituximab (RTX), an anti-human CD20 antibody has been shown to be highly effective in deleting expanded B-clones and improving MC syndrome [5][6][7][8][9][10][11][12][13] and other autoimmune conditions [14][15][16][17] in a majority of cases. However, no data are presently available on the very longterm efficacy and safety after RTX administration in MC, nor on the possible indications of maintenance therapy.…”

Section: Introductionmentioning

confidence: 99%

“…In this prospective, single center open study, we focused on the very long-term effects of RTX administration in a large cohort of severe MC patients who were administered the '4 + 2' infusion protocol [5,14] . This intensive treatment was associated with long-lasting remission in most patients, despite the absence of maintenance therapy with immunosuppressive agents.…”

Section: Introductionmentioning

confidence: 99%

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Improved (4 Plus 2) Rituximab Protocol for Severe Cases of Mixed Cryoglobulinemia: A 6-Year Observational Study

Roccatello

Sciascia²,

Baldovino³

et al. 2016

Am J Nephrol

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Background: In a prospective, single-center open study, we evaluated the very long-term effects of rituximab (RTX) administered to patients with severe mixed cryoglobulinemia (MC). Methods: RTX was administered to 31 patients with MC (type II in 29 cases and type III in 2) with diffuse membranoproliferative glomerulonephritis (16 cases), peripheral neuropathy (26) and large skin ulcers (7). All but 4 patients had serum anti-hepatitis C virus antibodies. RTX was administered at a dose of 375 mg/m², according to a ‘4 + 2' protocol (days 1, 8, 15 and 22 plus 1 dose 1 and 2 months later). No other immunosuppressive drugs were added. Response was evaluated over a very long-term follow-up (mean 72.47 months, range 30-148). Results: Complete remission of pretreatment active manifestations was observed in all cases of purpuric lesions and non-healing vasculitic ulcers, and in 80% of the peripheral neuropathies. Cryoglobulinemic nephropathy significantly improved during follow-up, starting from the 2nd month after RTX (serum creatinine from 2.1 ± 1.7 to 1.5 ± 1.6 mg/dl, p ≤ 0.05; 24-hour proteinuria from 2.3 ± 2.1 to 0.9 ± 1.9 g/24 h, p ≤ 0.05). Improvement of cryoglobulinemic serological hallmarks, such as cryocrit and low complement C4, were observed. No clinically relevant side effects were recorded. Re-induction with RTX was carried out in 9 relapsed patients after a mean of 31.1 months (12-54), again with beneficial effects. The survival rate was 75% at 6 years and the probability of remaining symptom-free for 10 years without any therapy was of about 60% after a single ‘4 + 2' infusion cycle, while the probability of living symptom-free 5 years after relapsing was 80% if given the same treatment. Conclusion: In this open, prospective study, RTX appeared to be very effective and safe in the treatment of the most severe cases of MC.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Improved (4 Plus 2) Rituximab Protocol for Severe Cases of Mixed Cryoglobulinemia: A 6-Year Observational Study

Roccatello

Sciascia²,

Baldovino³

et al. 2016

Am J Nephrol

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“…Belimumab was considered the first biologic to use when clinical involvement corresponds to the inclusion criteria of the belimumab pivotal trials (mainly skin, mucosal and articular complications and absence of kidney and central nervous system involvement). For patients with renal complications or autoimmune cytopenias, despite the negative results of the randomized placebo-controlled LUNAR and EXPLORER trials (27,28), the experts favored rituximab as the first biologic to use in light of the large amount of positive observational evidence (open trials and registries) (29)(30)(31)(32)(33). This position needs to be reevaluated in light of the results of the ongoing randomized trials evaluating belimumab and rituximab in renal lupus (7,34).…”

Section: Accepted Manuscriptmentioning

confidence: 99%

International and multidisciplinary expert recommendations for the use of biologics in systemic lupus erythematosus

Kleinmann

Tubach

Guern

et al. 2017

Autoimmunity Reviews

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“…Moreover, RTX is a valuable option in the treatment of several connective tissue diseases [11,12,13] and immune-meditated glomerular diseases such as idiopathic membranous nephropathy [14,15] and Henoch-Schonlein purpura nephritis [16]. RTX has emerged as an alternative treatment of frequently relapsing, steroid-dependent or steroid-resistant nephrotic syndrome in children [17,18,19,20].…”

Section: Introductionmentioning

confidence: 99%

High-Dose Rituximab Ineffective for Focal Segmental Glomerulosclerosis: A Long-Term Observation Study

Roccatello¹,

Sciascia²,

Rossi³

et al. 2017

Am J Nephrol

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Background: A beneficial effect of rituximab (RTX) on focal segmental glomerulosclerosis (FSGS) in pediatric patients or in transplant recipients has been reported in isolated cases. However, the use of RTX in adult patients with idiopathic FSGS needs further investigation. Methods: Eight patients who had biopsy-proven FSGS (63.9 ± 14.0, range 40-81 years, 4 women, 4 men) with major risk factors precluding corticosteroids or conventional immunosuppression were treated with a high dose of RTX (8 weekly doses of 375 mg/m²) and prospectively followed up for at least 2 years (29.1 ± 8.8 months, range 24-42 months). Results: RTX failed to improve proteinuria in 7 out of 8 patients, who had persistent nephrotic proteinuria. In one case, a rapidly deteriorating renal function was also observed. Only one patient showed an improvement in renal function and a remarkable reduction in proteinuria. There were no differences in clinical or laboratory characteristics or in the CD20 B lymphocyte count after RTX between the responder and the 7 nonresponder patients. Conclusions: Only a minority (1 of 8) in our series of adult patients with FSGS showed positive effects of high doses of RTX. Future studies are warranted to investigate more promising therapeutic options in the management of FSGS.

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A 4-year observation in lupus nephritis patients treated with an intensified B-lymphocyte depletion without immunosuppressive maintenance treatment—Clinical response compared to literature and immunological re-assessment

Cited by 56 publications

References 41 publications

Improved (4 Plus 2) Rituximab Protocol for Severe Cases of Mixed Cryoglobulinemia: A 6-Year Observational Study

Improved (4 Plus 2) Rituximab Protocol for Severe Cases of Mixed Cryoglobulinemia: A 6-Year Observational Study

International and multidisciplinary expert recommendations for the use of biologics in systemic lupus erythematosus

High-Dose Rituximab Ineffective for Focal Segmental Glomerulosclerosis: A Long-Term Observation Study

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