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Abstract Number: 2782

Retreatment With Rituximab In The Rituximab In ANCA-Associated Vasculitis (RAVE) Trial

Eli Miloslavsky1, Ulrich Specks2, Peter A Merkel3, Philip Seo4, Robert F. Spiera5, Carol A. Langford6, Gary S. Hoffman7, Cees G.M. Kallenberg8, E. William St Clair9, Nadia Tchao10, Linna Ding11, David Ikle12, Brett Jepson12, Paul Brunetta13 and John H. Stone14, 1Division of Rheumatology, Massachusetts General Hopsital, Boston, MA, 2Mayo Clinic, Rochester, MN, 3Division of Rheumatology, University of Pennsylvania and VA Medical Center, Philadelphia, PA, 4Rheumatology Division, Johns Hopkins Vasculitis Center, Johns Hopkins University, Baltimore, MD, 5Rheumatology, Hospital for Special Surgery, New York, NY, 6Center for Vasculitis Care and Research, Cleveland Clinic, Cleveland, OH, 7Center for Vasculitis Care and Research, Cleveland Clinic Foundation, Cleveland, OH, 8Rheumatology and Clinical Immunology, University Medical Center Groningen, Groningen, Netherlands, 9Medicine, Duke Unversity Medical Center, Durham, NC, 10Immune Tolerance Network, Bethesda, MD, 11NIAID, Bethesda, MD, 12Rho, Chapel Hill, NC, 13Biotherapeutics, Genentech, So San Francisco, CA, 14Rheumatology, Massachusetts General Hospital, Boston, MA

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: ANCA, Rituximab, treatment and vasculitis

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Session Information

Session Title: Vasculitis III

Session Type: Abstract Submissions (ACR)

Background/Purpose:

Retrospective studies have demonstrated that repeat rituximab treatment may be effective in re-inducing remission in relapsing ANCA-associated vasculitis. We analyzed data from the Rituximab in ANCA-associated vasculitis (RAVE) trial in order to determine the safety and efficacy of a second course of rituximab for relapsing granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Methods:

Randomized controlled trial comparing rituximab (RTX, n=99) to cyclophosphamide (CYC) followed by azathioprine (AZA, n=98) for remission induction. Patients who suffered a severe disease flare (BVAS/WG > 3 or one major BVAS/WG item) between 6 and 18 months were eligible for open label RTX (OLR) (375mg/m2 once weekly times four).

Results:

17 patients received two courses of RTX.  Baseline characteristics are presented in the table. 

Serial RTX.jpg

After retreatment, patients were followed for an average of 301 days (range 35-427). Treatment with OLR led to remission (BVAS/WG=0) in 15 of 17 patients (88%) by an average of 55 days (range 1-181). One patient with diffuse alveolar hemorrhage did not improve and died 7 weeks after the initial flare.  Another patient reached a BVAS/WG of 1 before suffering a limited flare at 12 months after OLR. 

Six months after OLR, 15 patients (88%) were in remission (BVAS/WG = 0), 8 (47%) had achieved complete response (BVAS/WG = 0 and prednisone ≤ 10mg/day) and 6 patients (35%) were in complete remission (BVAS/WG = 0 and prednisone = 0).  After 12 months, 13 patients (76%) had achieved complete responses and 8 (47%) had reached complete remission.  There were 4 limited and no severe flares among the 17 patients (BVAS/WG 2.5) over one year of follow up after OLR. 

There were a total of 3 severe (grade ≥ 3) adverse events after OLR, including one death (described above), metastatic colon cancer, and severe sinusitis.

Conclusion:

This prospective study indicates that retreatment of GPA or MPA flares with rituximab is effective in re-inducing remission.

           


Disclosure:

E. Miloslavsky,

Genentech Inc,

9;

U. Specks,
None;

P. A. Merkel,
None;

P. Seo,
None;

R. F. Spiera,

Roche Pharmaceuticals, g,

2;

C. A. Langford,

Bristol-Myers Squibb,

9,

Genentech and Biogen IDEC Inc.,

9;

G. S. Hoffman,
None;

C. G. M. Kallenberg,

Roche,

8;

E. W. St Clair,
None;

N. Tchao,
None;

L. Ding,
None;

D. Ikle,

Rho,

3;

B. Jepson,

Rho,

3;

P. Brunetta,

Genentech Inc,

3;

J. H. Stone,

Genentech and Biogen IDEC Inc.,

2,

Genentech and Biogen IDEC Inc.,

5,

Roche Pharmaceuticals,

2.

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