Friday, 25 May 2018

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Fixed and Tailored Rituximab Regimens Equal in ANCA Associated Vasculitis

The French Vasculitis Study Group has published the results of the MAINRITSAN2 trial designed to  compare individually tailored versus fixed-schedule rituximab (RTX) reinfusion for remission maintenance in patients with antineutrophil cytoplasm antibody (ANCA)-associated vasculitides (AAVs). 

Investigators enrolled 162 adult patients with either newly diagnosed or relapsing granulomatosis with polyangiitis (GPA) (72.2%) or microscopic polyangiitis (MPA) (27.8%).  Patients had previously received induction therapy with either cyclophosphamide (61.7%), rituximab (37.6%) or methotrexate (0.6%).

Tailored-RTX patients received a 500 mg rituximab infusion initially and were retreated only only when CD19+B lymphocytes or ANCA had reappeared or ANCA titre rose markedly, until month 18. Fixed dose RTX controls received a fixed 500 mg rituximab infusion on days 0 and 14 postrandomisation, then 6, 12 and 18 months after the first infusion. The primary endpoint was the number of relapses (new or reappearing symptom(s) or worsening disease with Birmingham Vasculitis Activity Score (BVAS)>0) at month 28.

At month 28, 21 patients had suffered 22 relapses:

  • Tailored patients = 17.3% relapse rate
  • Fixed patients =  9.9%  (p=0.22).

AAV relapse rates did not differ significantly between individually tailored and fixed-schedule rituximab regimens. However,  patients receiving tailored RTX had fewer rituximab infusions. 

 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Rheumatologists' Comments

I dunno. Based on what you’re showing I would certainly favor fixed dosing. Almost 20% relapses vs only 10%. Looks to me like an underpowered study.
We need to stop letting the p-value be the final decider about what we think is important and what isn’t.

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