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

Session Information

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.

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,

U. Specks,
None;

P. A. Merkel,
None;

P. Seo,
None;

R. F. Spiera,

Roche Pharmaceuticals, g,

C. A. Langford,

Bristol-Myers Squibb,

Genentech and Biogen IDEC Inc.,

G. S. Hoffman,
None;

C. G. M. Kallenberg,

Roche,

E. W. St Clair,
None;

N. Tchao,
None;

L. Ding,
None;

D. Ikle,

Rho,

B. Jepson,

Rho,

P. Brunetta,

Genentech Inc,

J. H. Stone,

Genentech and Biogen IDEC Inc.,

Roche Pharmaceuticals,

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