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Abstract Number: 1955

Rituximab Versus Azathioprine to Maintain Remission of ANCA-Associated Vasculitides (MAINRITSAN): Follow-up at 60 Months

Benjamin Terrier1, Christian Pagnoux2, Elodie Perrodeau3, Alexandre Karras4, Chahéra Khouatra5, Olivier Aumaître6, Pascal Cohen7, Francois Maurier8, Olivier Decaux9, Hélène Desmurs-Clavel10, Pierre Gobert11, Thomas Quémeneur12, Claire Blanchard-Delaunay13, Pascal Godmer14, Xavier Puéchal15, Luc Mouthon15, Philippe Ravaud16 and Loïc Guillevin15, 1National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, France, 2Mount Sinai Hospital, Toronto, ON, Canada, 3Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France, 4Nephrology, HEGP, Paris, France, 5CHU Lyon, Lyon, France, 6CHU Pitié-Salpêtrière - Department of Internal Medicine 2. Referal center for SLE/APS, Paris, France, 7Internal Medicine, Cochin Hospital, Paris, France, 8Department of Internal Medicine, HP Metz Belle Isle Hospital, Metz, France, 9Department of Internal Medicine, Rennes University Hospital, Rennes, France, 10Department of Internal Medicine 2. Referal center for SLE/APS, CHU Pitié-Salpêtrière, Paris, France, 11Nephrology, Centre Hospitalier d'Avignon, Avignon, France, 12Service de néphrologie, médecine interne et vasculaire, Hôpital de Valenciennes, Valenciennes, France, 13Internal Medicine, Centre Hospitalier, Niort, France, 14CH Vannes, Vannes, France, 15Department of Internal Medicine, Referral Center for Rare Autoimmune and Systemic Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, France, Paris, France, 16Hôpital Hôtel Dieu, Paris, France

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: ANCA, azathioprine, outcomes, rituximab and vasculitis

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Session Information

Date: Monday, November 14, 2016

Session Title: Plenary Session II: Discovery 2016

Session Type: ACR Plenary Session

Session Time: 11:00AM-12:30PM

Background/Purpose: The previously reported prospective, randomizedÐcontrolled MAINRITSAN trial compared rituximab (RTX) to azathioprine (AZA) for maintenance of ANCA-associated vasculitis (AAV) remissions obtained with a combined cyclophosphamide and glucocorticoid (GC) induction regimen. Patients were randomly assigned to receive 500-mg RTX infusions on D1, D15 and 5.5 months later, then every 6 months until 18 months, or AZA for 22 months (initial dose: 2 mg/kg/d). Trial results demonstrated that RTX was superior to AZA at maintaining AAV remission during the planned 28 months of follow-up. We now report the pre-specified long-term outcomes at 60 months of MAINRITSAN trial patients.

Methods: SurvivorsÕ outcomes were ascertained prospectively. Data on survival, relapse, cancers, cardiovascular morbidity and other adverse events were collected from physicians. All patients were analyzed according to randomization group. Quality-adjusted time-without-symptoms-and-toxicity (Q-TWiST) analysis was computed, with the aim of better discerning the therapeutic impact and tradeoffs between treatment toxicity (severe adverse events, SAEs) and disease activity (relapse).

Results: Data from 60 months of follow-up were available for 110 (96%) of the 115 randomized participants. For the RTX- and AZA-treated groups, respectively: 0 and 4 died; 60-month overall survival rates were 100% and 93.0% [95% CI 86.7Ð99.9%] (P=0.045); all-relapseÐfree survival rates were 57.9% [95% CI 46.4Ð72.2%] and 37.2% [95% CI 26.5Ð52.2%] (P=0.012); and major relapse-free survival rates were 71.9% [95% CI 61.2Ð84.6%)] and 49.4% [95% CI 38.0Ð64.3%] (P=0.003). In contrast, no between-group differences were observed for survival without SAEs (P=0.95) and the cumulative GC dose (P=0.11) at 60 months.

For RTX-treated patients, PR3-ANCA positivity or ANCA persistence 12 months after starting maintenance therapy were associated with higher major relapse rates. During the 60-month follow-up, RTX- and AZA-arm patients had similar amounts of time spent with SAEs (P=0.21), whereas the former, compared to the latter, spent 9.7 months less with major relapses (P<0.001) and 12.6 months more without relapse or toxicity (P<0.001). The threshold utility analysis at 60 months showed that the Q-TWiST period was significantly longer for RTX- than AZA-arm patients (55.2 vs. 47.95 months, respectively, P<0.001) (Figure).

Conclusion: This long-term analysis showed that, despite late relapses after the 28-month initial follow-up period, maintenance therapy with RTX remained significantly superior to AZA to maintain remission at 60 months and was associated with better survival. ANCA monitoring seems to be relevant to guide treatment duration.


Disclosure: B. Terrier, None; C. Pagnoux, None; E. Perrodeau, None; A. Karras, None; C. Khouatra, None; O. Aumaître, None; P. Cohen, None; F. Maurier, None; O. Decaux, None; H. Desmurs-Clavel, None; P. Gobert, None; T. Quémeneur, None; C. Blanchard-Delaunay, None; P. Godmer, None; X. Puéchal, None; L. Mouthon, None; P. Ravaud, None; L. Guillevin, None.

To cite this abstract in AMA style:

Terrier B, Pagnoux C, Perrodeau E, Karras A, Khouatra C, Aumaître O, Cohen P, Maurier F, Decaux O, Desmurs-Clavel H, Gobert P, Quémeneur T, Blanchard-Delaunay C, Godmer P, Puéchal X, Mouthon L, Ravaud P, Guillevin L. Rituximab Versus Azathioprine to Maintain Remission of ANCA-Associated Vasculitides (MAINRITSAN): Follow-up at 60 Months [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/rituximab-versus-azathioprine-to-maintain-remission-of-anca-associated-vasculitides-mainritsan-follow-up-at-60-months/. Accessed February 26, 2021.
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