PMID- 25047592 OWN - NLM STAT- MEDLINE DCOM- 20150210 LR - 20240321 IS - 2326-5205 (Electronic) IS - 2326-5191 (Print) IS - 2326-5191 (Linking) VI - 66 IP - 11 DP - 2014 Nov TI - Rituximab for the treatment of relapses in antineutrophil cytoplasmic antibody-associated vasculitis. PG - 3151-9 LID - 10.1002/art.38788 [doi] AB - OBJECTIVE: Disease relapses are frequent in antineutrophil cytoplasmic antibody-associated vasculitis (AAV). This study was undertaken to evaluate outcomes in patients with AAV who are re-treated with rituximab (RTX) and prednisone for severe disease relapses. METHODS: The Rituximab in AAV trial was a randomized, double-blind, placebo-controlled trial comparing the rates of remission induction among patients treated with RTX (n = 99) and patients treated with cyclophosphamide (CYC) followed by azathioprine (AZA) (n = 98). Prednisone was tapered to discontinuation after 5.5 months. After remission was achieved, patients who experienced a severe disease relapse between months 6 and 18 were eligible to receive RTX and prednisone on an open-label basis according to a prespecified protocol. Investigators remained blinded with regard to the original treatment assignment. RESULTS: Twenty-six patients received RTX for disease relapse after remission had initially been achieved with their originally assigned treatment. Fifteen of these patients were initially randomized to receive RTX and 11 to receive CYC/AZA. Thirteen (87%) of the patients originally assigned to receive RTX and 10 (91%) originally assigned to receive CYC/AZA achieved remission again with open-label RTX (an overall percentage of 88%). In half of the patients treated with open-label RTX, prednisone could be discontinued entirely. Patients in this cohort experienced fewer adverse events compared to the overall study population (4.7 adverse events per patient-year versus 11.8 adverse events per patient-year). CONCLUSION: Re-treatment of AAV relapses with RTX and glucocorticoids appears to be a safe and effective strategy, regardless of previous treatment. CI - Copyright (c) 2014 by the American College of Rheumatology. FAU - Miloslavsky, E M AU - Miloslavsky EM AD - Massachusetts General Hospital, Boston. FAU - Specks, U AU - Specks U FAU - Merkel, P A AU - Merkel PA FAU - Seo, P AU - Seo P FAU - Spiera, R AU - Spiera R FAU - Langford, C A AU - Langford CA FAU - Hoffman, G S AU - Hoffman GS FAU - Kallenberg, C G M AU - Kallenberg CG FAU - St Clair, E W AU - St Clair EW FAU - Tchao, N K AU - Tchao NK FAU - Viviano, L AU - Viviano L FAU - Ding, L AU - Ding L FAU - Ikle, D AU - Ikle D FAU - Villarreal, M AU - Villarreal M FAU - Jepson, B AU - Jepson B FAU - Brunetta, P AU - Brunetta P FAU - Allen, N B AU - Allen NB FAU - Fervenza, F C AU - Fervenza FC FAU - Geetha, D AU - Geetha D FAU - Keogh, K AU - Keogh K FAU - Kissin, E Y AU - Kissin EY FAU - Monach, P A AU - Monach PA FAU - Peikert, T AU - Peikert T FAU - Stegeman, C AU - Stegeman C FAU - Ytterberg, S R AU - Ytterberg SR FAU - Stone, J H AU - Stone JH CN - Rituximab in ANCA-Associated Vasculitis-Immune Tolerance Network Research Group LA - eng SI - ClinicalTrials.gov/NCT00104299 GR - UL1-RR-025771/RR/NCRR NIH HHS/United States GR - UL1 RR025005/RR/NCRR NIH HHS/United States GR - N01 AI015416/AI/NIAID NIH HHS/United States GR - K23 AR052820/AR/NIAMS NIH HHS/United States GR - M01 RR000533/RR/NCRR NIH HHS/United States GR - UL1 RR025771/RR/NCRR NIH HHS/United States GR - K24 AR002224/AR/NIAMS NIH HHS/United States GR - M01-RR-00533/RR/NCRR NIH HHS/United States GR - K24 AR049185/AR/NIAMS NIH HHS/United States GR - UL1 RR024150/RR/NCRR NIH HHS/United States GR - K23-AR-052820/AR/NIAMS NIH HHS/United States GR - N01AI15416/AI/NIAID NIH HHS/United States GR - 1 UL1-RR-024150-01/RR/NCRR NIH HHS/United States GR - K24-AR-049185/AR/NIAMS NIH HHS/United States GR - K24-AR-02224/AR/NIAMS NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PL - United States TA - Arthritis Rheumatol JT - Arthritis & rheumatology (Hoboken, N.J.) JID - 101623795 RN - 0 (Antibodies, Monoclonal, Murine-Derived) RN - 0 (Antirheumatic Agents) RN - 0 (Glucocorticoids) RN - 4F4X42SYQ6 (Rituximab) RN - 8N3DW7272P (Cyclophosphamide) RN - MRK240IY2L (Azathioprine) RN - VB0R961HZT (Prednisone) SB - IM MH - Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/*drug therapy/*prevention & control MH - Antibodies, Monoclonal, Murine-Derived/*therapeutic use MH - Antirheumatic Agents/*therapeutic use MH - Azathioprine/therapeutic use MH - Cyclophosphamide/therapeutic use MH - Double-Blind Method MH - Drug Therapy, Combination MH - Glucocorticoids/therapeutic use MH - Humans MH - Prednisone/therapeutic use MH - Prospective Studies MH - Recurrence MH - Remission Induction/methods MH - Rituximab MH - Secondary Prevention/*methods MH - Time Factors MH - Treatment Outcome PMC - PMC4229846 MID - NIHMS630196 EDAT- 2014/07/23 06:00 MHDA- 2015/02/11 06:00 PMCR- 2015/11/01 CRDT- 2014/07/23 06:00 PHST- 2014/01/27 00:00 [received] PHST- 2014/07/15 00:00 [accepted] PHST- 2014/07/23 06:00 [entrez] PHST- 2014/07/23 06:00 [pubmed] PHST- 2015/02/11 06:00 [medline] PHST- 2015/11/01 00:00 [pmc-release] AID - 10.1002/art.38788 [doi] PST - ppublish SO - Arthritis Rheumatol. 2014 Nov;66(11):3151-9. doi: 10.1002/art.38788.