Friday, 18 Jan 2019

You are here

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.

More Like This

Early Predictive Factors for Scleroderma Renal Crisis

It has been historically said that risk factors for scleroderma renal crisis (SRC) includes include cold exposure, steroid use, dehydration, rapid progression of skin disease, tendon friction rubs, anti-RNA polymerase III antibodies and pregnancy.  A new study examines risk factor for SRC at the onset and diagnosis in systemic sclerosis patients. 

Best of 2018: Ustekinumab May be Effective in Lupus

Ronald F van Vollenhoven and colleagues have reported in Lancet that ustekinumab (UST), an interleukin-12 and -23 inhibitor, when added to usual therapy in systemic lupus erythematosus (SLE) patients, was shown to be superior to placebo at improving clinical efficacy and laboratory parameters after 6 months of therapy.

Nailfold Videocapillaroscopy in Dermatomyositis

A study of nailfold videocapillaroscopy (NVC) in patients with idiopathic inflammatory myopathies (IIMs) finds abnormalities in more than half of patients suggesting this could be a useful clinical tool in diagnosing and managing patients with IIM. 

TIF1-Ab in Dermatomyositis Linked to Higher Cancer Risk

Several epidemiological studies have reported that a diagnosis of DM or PM may be associated with increased cancer risk. The association appears stronger for DM than PM. Based on a meta-analysis, DM cancer risk is five times higher than in the general population and twice that compared with PM cancer risk. 

Genetic Diagnosis for Previously Undiagnosed Disorders

The NEJM has reported the NIH's Undiagnosed Diseases Network (UDN) study results of genetically identifying new diseases from prospectively followed persons with undiagnosed disorders. The UDN was formed in 2014 as a network of seven clinical sites, two sequencing cores, a coordinating center, central biorepository, a metabolomics core, and a model organisms screening center. It was established to apply a multidisciplinary model in the evaluation of the most challenging cases and to identify the biologic characteristics of newly discovered diseases.