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2017 ; 8
(32
): 52072-52077
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The "4 plus 2" rituximab protocol makes maintenance treatment unneeded in
patients with refractory ANCA-associated vasculitis: A 10 years observation
study
#MMPMID28881714
Roccatello D
; Sciascia S
; Rossi D
; Alpa M
; Naretto C
; Radin M
; Fenoglio R
; Baldovino S
; Menegatti E
Oncotarget
2017[Aug]; 8
(32
): 52072-52077
PMID28881714
show ga
BACKGROUND: ANCA associated vasculitides (AAV) often present with a chronic
relapsing course. Relapse leads to increased immunosuppressive exposure and
consequent toxicity. While two randomized controlled trials have shown rituximab
(RTX) to be the most effective induction treatment in patients with relapsing
disease, the optimal treatment duration and RTX dose remain debated. Whether to
administer a maintenance dose to every patient, at a fixed time interval or on
the basis of B cell count and ANCA titre or only when disease manifestations do
occur is still debated as well. METHODS: 11 patients (5 with granulomatosis with
polyangiitis, 4 with microscopic polyangiitis-MPA-, and 2 with eosinophilic
granulomatosis with polyangiitis -EGPA-) intolerant or refractory to conventional
therapies including cyclophosphamide were enrolled. All patients received the so
called "improved 4+2" RTX scheme as a rescue therapy. Following RTX
administration, immunosuppressive drugs were rapidly tapered and no
immunosuppressive maintenance therapy had been given. RESULTS: After a mean
follow-up of 85 months since the "4+2" RTX protocol: four out of 11 patients
(37%, 1 EGPA and 3 MPA, all MPO-positive) remained in remission after one cycle
of "4+2" RTX infusion protocol with no relapse for a median 66 months [60-108]).
Seven relapsing patients were re-treated once with RTX (again as monotherapy with
the same protocol) after a median of 54 months (24-96). Following re-treatment,
they again showed complete remission over a median of 32 months (12-96) of
observation. CONCLUSION: In one of the longest-term observation (85 months)
studies, sustained clinical remission without immunosuppressive maintenance
therapy (and a negligible dose of prednisone since the 5(th)month) was obtained
by the "4 + 2" RTX infusion protocol in patients with ANCA-associated vasculitis
intolerant or refractory to conventional therapy.