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Abstract Number: 1689

Off-Label Use of Biotherapies to Treat Relapsing And/or Refractory Polyarteritis Nodosa

Alice Canzian 1, Omer Karadag 2, Anne Contis 3, François Maurier 4, Silvia Sartorelli 5, Laure Denis 6, Sébastien Sanges 7, Claire de Moreuil 8, Cécile-Audrey Durel 9, Stéphane Durupt 10, Marie Jachiet 11, Diane Rouzaud 12, Carlo Salvarani 13, Franco Schiavon 14, Lorenzo Dagna 15, Fabrice Bonnet 16, David Jayne 17, Loic Guillevin 18 and Benjamin Terrier1, 1Cochin Hospital, Paris, France, 2Hacettepe University Vasculitis Centre, Ankara, Turkey / Vasculitis and Lupus Clinic, Addenbrooke’s Hospital, University of Cambridge, UK, Ankara, Turkey, 3Department of Internal Medicine and Clinical Immunology , Hôpital Saint-André, CHU de Bordeaux , Bordeaux , France, Bordeaux, France, 4Service de Médecine Interne, Hôpital Belle Isle, Metz, Metz, France, 5Vita-Salute San Raffaele University, IRCCS San Raffaele Hospital, Milan, Italy, 6Clermont-Ferrand Hospital, Clermont-Ferrand, France, 7CHRU Lille, Lille, France, 8CHU Brest, Brest, France, 9Department of Internal Medicine, Hôpital Edouard Herriot, Lyon, France, Lyon, France, 10Lyon Hospital, Lyon, France, 11Saint Louis Hospital, Paris, France, 12Bichat Hospital, Paris, France, 13Division of Rheumatology, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy, 14Operative Unit of Rheumatology, Department of Medicine DIMED, University of Padova, Padova, Italy, Padova, Italy, 15Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy, 16CHU Bordeaux, Bordeaux, France, 17Vasculitis and Lupus Clinic, Addenbrooke’s Hospital, University of Cambridge, UK, Cambridge, United Kingdom, 18National Referral Center for Rare Systemic Autoimmune Diseases Paris Cochin, Paris, France

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Biologic agents and systemic vasculitides, Polyarteritis nodosa

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Session Information

Date: Monday, November 11, 2019

Title: Vasculitis – Non-ANCA-Associated & Related Disorders Poster III: Behçet’s Disease & Other Vasculitides

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Polyarteritis nodosa (PAN) is a rare systemic necrotizing vasculitis of medium- and small-sized arteries, not associated with antineutrophil cytoplasmic antibodies (ANCA). Conventional treatments include glucocorticoids (GCs) for non-severe disease, and combined GCs and immunosuppressants for severe disease. Nevertheless, some patients have refractory and/or relapsing disease. We examined off-label biotherapy use for relapsing/refractory PAN.

Methods: This retrospective European collaborative study included patients with PAN meeting ACR criteria and/or Chapel Hill Consensus Conference 2012 definitions. Treatment efficacy and safety were recorded. Remission was defined as the absence of vasculitis manifestations (BVAS = 0) with ≤5 mg/day of prednisone. Partial response was defined as BVAS = 0, with 6–10 mg/day of prednisone.

Results: Fifty-two patients (24 men and 28 women; median age 51 years) were included. Nineteen (37%) patients received TNF-α blockers, 16 (31%) rituximab (RTX), 9 (17%) tocilizumab (TCZ), and 8 (15%) other biologics (i.e. alemtuzumab for 3, anakinra for 2, interferon-α for 2 and abatacept for 1). Previous treatments were: GCs for all, including methylprednisolone infusions (73%), cyclophosphamide (62%), azathioprine (54%), mycophenolate mofetil (48%) or methotrexate (46%). At inclusion, median BVAS was 5 (range 0-18), including 5 (2-12) for the TNF-α blocker group, 5 (2-12) for the RTX recipients and 4 (0-6) for those given TCZ.

At month (M) 6 and M12, respectively, median BVAS fell to 3 and 0 for TNF-α blockers group, to 3.5 and 0 for those given RTX, and to 0 and 0 for the TCZ group. Median GCs dose declined from baseline 17.5 mg/day to 10 at 6 months and 5 at 12 months for the TNF-α blocker recipient, from 15 to 10 and 5 mg/day for those given RTX, respectively, and from 15 to 7 and 5 mg/day for the TCZ group.

Nine (47%) patients stopped TNF-α blockers: for adverse events in 2 and/or refractory disease in 8. Refractory disease led 6 (38%) to stop RTX. Finally, 4 (44%) stopped TCZ: 2 for adverse events (testicular abscess and worsening renal failure), and 2 for refractory disease. Two additional patients had to decrease the dose because of cytopenias.

After median follow-up of 34.4 [IQR 21.5–59.5] months, remissions, partial responses, treatment failure and stop for adverse event, respectively, occurred in 43%, 5%, 47% and 5% for TNF-α blockers recipients, 31%, 13%, 56% and 0% for RTX recipients, and 56%, 0%, 22% and 22% for TCZ recipients. No remission was noted in patients treated with anakinra, alemtuzumab, interferon-α and abatacept.

Conclusion: These results suggest that TNF-α blockers and TCZ could achieve higher remission and GC-sparing rates for relapsing and/or refractory PAN than other biologics. Our findings warrant further study to confirm or refute them.


Disclosure: A. Canzian, None; O. Karadag, None; A. Contis, None; F. Maurier, None; S. Sartorelli, None; L. Denis, None; S. Sanges, None; C. de Moreuil, None; C. Durel, None; S. Durupt, None; M. Jachiet, None; D. Rouzaud, None; C. Salvarani, None; F. Schiavon, None; L. Dagna, AbbVie, 5, Amgen, 5, Biogen, 5, Bristol-Myers Squibb, 5, Celltrion, 5, Novartis, Pfizer, 5, Sanofi-Genzyme, 5, SOBI, 2, 5; F. Bonnet, None; D. Jayne, Astra Zeneca, 5, Boehringer-Ingelheim, 5, Celgene, 5, ChemoCentryx, 2, 5, GSK, 2, 5, Infla-Rx, 5, InflaRx GmbH, 5, Insmed, 5, Roche Genetech, 2, Sanofi Genzyme, 2, Takeda, 5; L. Guillevin, None; B. Terrier, None.

To cite this abstract in AMA style:

Canzian A, Karadag O, Contis A, Maurier F, Sartorelli S, Denis L, Sanges S, de Moreuil C, Durel C, Durupt S, Jachiet M, Rouzaud D, Salvarani C, Schiavon F, Dagna L, Bonnet F, Jayne D, Guillevin L, Terrier B. Off-Label Use of Biotherapies to Treat Relapsing And/or Refractory Polyarteritis Nodosa [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/off-label-use-of-biotherapies-to-treat-relapsing-and-or-refractory-polyarteritis-nodosa/. Accessed .
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