Rituximab Efficacy during a Refractory Polyarteritis Nodosa Flare
Emanuel Ribeiro2009, Case Reports in Medicine
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Polyarteritis nodosa (PAN) is a systemic vasculitis whose severe forms are treated with glucocorticoids and cyclophosphamide. Refractory patients are exposed to many complications, notably accelerated atherosclerosis. We report a case report of 71-year-old man followed for polyarteritis nodosa refractory to glucocorticoids and cyclosphosphamide. Systemic vasculitis relapses are followed to accelerated atherosclerosis: severe ischemic lesions led to amputation of lower limbs. Remission of refractory PAN is obtained with rituximab. Disappearance of biological inflammatory is allowed to regression of ischemic lesions in upper limbs. In this situation, we recommend a systematic vascular work-up for patients suffered from refractory vasculitis. On the other hand, therapeutic trials are needed to determine the real efficacy and place of rituximab in the treatment of polyarteritis nodosa.
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Infliximab for the treatment of refractory polyarteritis nodosa
Clinical Rheumatology, 2019
Polyarteritis nodosa (PAN) is a necrotizing vasculitis predominantly affecting medium and small size arteries. Cyclophosphamide, a drug with narrow therapeutic range and poor safety profile, constitutes the treatment of choice for PAN vasculitis with major organ involvement. To describe our clinical experience in treating refractory PAN with infliximab (a TNF inhibitor), a drug with good tolerability and better safety profile than cyclophosphamide. Twenty-six PAN patients were admitted to our rheumatology unit between 2006 and 2017, of whom nine patients, with severe and refractory disease, were treated with infliximab after failure of standard treatment. We describe herein the patients' characteristics, clinical manifestations, severity and response to infliximab treatment and review the current literature. Complete remission was defined as the absence of features of active disease and withdrawal of prednisone therapy. Significant improvement was defined as clinical improvement and prednisone dose reduction of at least 50% or a 50% reduction in immune modulatory medications other than prednisone. After 4 months of treatment, 8/9 (89%) patients achieved significant improvement, with two of them achieving complete remission. We suggest that anti-TNF agents, and in particular infliximab, are relatively safe and efficacious treatment options in refractory PAN. A randomized controlled trial should be done in order to objectively evaluate infliximab in PAN.
Long-Term Effects of Rituximab Added to Cyclophosphamide in Refractory Patients with Vasculitis
American Journal of Nephrology, 2011
Background: Current therapies have changed systemic vasculitis from a disease with a high rate of mortality to a chronic curable condition. A limited percentage of patients either remains refractory to conventional treatment or experiences dose-limiting side effects. Methods: 11 patients (4 affected by idiopathic systemic microscopic polyangiitis, 5 by Wegener's granulomatosis, and 2 by Churg-Strauss syndrome) intolerant or refractory to conventional therapies including cyclophosphamide were enrolled. All patients received rituximab as a rescue therapy and were followed for 30-54 months. Following rituximab administration, immunosuppressive drugs were rapidly tapered and no immunosuppressive maintenance therapy was given. Results: Significant decreases in levels of serum creatinine, proteinuria, erythrocyte sedimentation rate, Creactive protein, and ANCA titers were observed during the follow-up (at least 30 months after rituximab administration). Arthralgia and weakness rapidly disappeared in all patients. Out of 7 patients, 5 reported a decrease in the degree of paresthesia and in the electrophysiologic parameters. Six months after rituximab administration the mean dose of prednisone was 5.5 mg/day. Conclusion: In this sample of patients with systemic vasculitis who were refractory or intolerant to more conventional treatment, rituximab proved to be safe and effective in a long-term follow-up, and showed steroid-and immunosuppressive-sparing effects allowing the persistence of long-lasting remissions without maintenance therapy.
Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis
Annals of the Rheumatic Diseases, 2020
ObjectivesEvaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial.MethodsPatients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4×375 mg/m2) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse.Results188 patients were studied: 95/188 (51%) men, median age 59 years (range 19–89), prior disease duration 5.0 years (range 0.4–34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activi...
Rituximab versus Cyclophosphamide for ANCA-Associated Vasculitis
New England Journal of Medicine, 2010
Background Cyclophosphamide and glucocorticoids have been the cornerstone of remissioninduction therapy for severe antineutrophil cytoplasmic antibody (ANCA)−associated vasculitis for 40 years. Uncontrolled studies suggest that rituximab is effective and may be safer than a cyclophosphamide-based regimen. Methods We conducted a multicenter, randomized, double-blind, double-dummy, noninferiority trial of rituximab (375 mg per square meter of body-surface area per week for 4 weeks) as compared with cyclophosphamide (2 mg per kilogram of body weight per day) for remission induction. Glucocorticoids were tapered off; the primary end point was remission of disease without the use of prednisone at 6 months. Results Nine centers enrolled 197 ANCA-positive patients with either Wegener's granulomatosis or microscopic polyangiitis. Baseline disease activity, organ involvement, and the proportion of patients with relapsing disease were similar in the two treatment groups. Sixty-three patients in the rituximab group (64%) reached the primary end point, as compared with 52 patients in the control group (53%), a result that met the criterion for noninferiority (P<0.001). The rituximab-based regimen was more efficacious than the cyclophosphamide-based regimen for inducing remission of relapsing disease; 34 of 51 patients in the rituximab group (67%) as compared with 21 of 50 patients in the control group (42%) reached the primary end point (P = 0.01). Rituximab was also as effective as cyclophosphamide in the treatment of patients with major renal disease or alveolar hemorrhage. There were no significant differences between the treatment groups with respect to rates of adverse events. Conclusions Rituximab therapy was not inferior to daily cyclophosphamide treatment for induction of remission in severe ANCA-associated vasculitis and may be superior in relapsing disease. (Funded by the National Institutes of Allergy and Infectious Diseases, Genentech, and Biogen; ClinicalTrials.gov number, NCT00104299.
Tofacitinib for polyarteritis nodosa: a tailored therapy
Annals of the Rheumatic Diseases, 2016
Tofacitinib is a novel inhibitor of Janus kinase (JAK) 3 and JAK1 is recently introduced as treatment for rheumatoid arthritis. 1 The JAK inhibitors are at the focus of research in a myriad of other inflammatory diseases 2 3 as the JAK-(signal transducer and activator of transcription) STAT pathway has a central role in cytokine signal transduction. We herein describe a case of refractory polyarteritis nodosa (PAN) successfully treated with tofacitinib. A 28-year-old man had been diagnosed with PAN at age 14. He presented with livedo reticularis, arthritis and skin nodules with arteritis/fibrinoid necrosis confirmed on biopsy. Immunological panel at the time of diagnosis was negative for antineutrophil cytoplasmic antibodies, anti-nuclear antibodies, anti-Ro/SS-A antibodies, anti-La/SS-B antibodies, rheumatoid factor, with normal complement levels. He was treated with azathioprine and methotrexate for several years with drug-controlled complete remission. At age 24, his disease flared and he began to suffer from necrotic lesions of the scrotum and calves, excruciating abdominal pain and polyarthritis, with high C-reactive protein (CRP) levels (160-300 mg/L) for which he received recurrent intravenous methylprednisolone pulses and oral prednisone 40-60 mg daily between pulses. Numerous treatments, including: infliximab, adalimumab, rituximab, etanercept, tocilizumab, potassium iodide and cyclophosphamide intravenous and oral, failed to obtain remission. He was hospitalised for re-evaluation that included CT angiography of the chest and abdomen, echocardiography, viral serology, blood cultures, toxic screen, anti-infliximab antibodies and genetic mutation of adenosine deaminase 2, all of which were normal or negative. 4 Treatment with plasma exchange for 3 weeks achieved partial remission, but had to be discontinued due to central line sepsis. At this point, he was in a severe long-standing inflammatory
Is Rituximab Superior to Cyclophosphamide for ANCA-Associated Vasculitis for Induction of Remission, and with a Better Safety Profile?
Current Rheumatology Reports, 2010
Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis
The New England journal of medicine, 2014
The combination of cyclophosphamide and glucocorticoids leads to remission in most patients with antineutrophil cytoplasm antibody (ANCA)-associated vasculitides. However, even when patients receive maintenance treatment with azathioprine or methotrexate, the relapse rate remains high. Rituximab may help to maintain remission. Patients with newly diagnosed or relapsing granulomatosis with polyangiitis, microscopic polyangiitis, or renal-limited ANCA-associated vasculitis in complete remission after a cyclophosphamide-glucocorticoid regimen were randomly assigned to receive either 500 mg of rituximab on days 0 and 14 and at months 6, 12, and 18 after study entry or daily azathioprine until month 22. The primary end point at month 28 was the rate of major relapse (the reappearance of disease activity or worsening, with a Birmingham Vasculitis Activity Score >0, and involvement of one or more major organs, disease-related life-threatening events, or both). The 115 enrolled patients ...
Now also at Masaryk University in Brno
Since the 1st of January 2024 I am part-time employed at Masaryk University in Brno as member of the exiting project on the invitation of Prof. Dr. Jiri Macháchek: Ready for the future: understanding long-term resilience of the human culture (RES-HUM) Project identification: CZ.02.01.01/00/22_008/0004593 An excellent opportunity to get more familiar with central European archaeology!
An Architectural Investigation of Leisure Spaces in the Roman Domestic Context: The Case of Ephesus
Leisure is most basically defined as "the time free from work". The ancient conception and forms of leisure were quite different from the modern ones, which came into discussion during the industrial era. The Roman society was highly stratified and comprised of diverse social classes for which leisure acquired different forms and meanings. Every stratum of the Roman society enjoyed the possibilities and pleasures of leisure proportional to its hierarchy in the social system, so that leisure can be investigated in both public and private contexts in the Roman world. This study aims to investigate "leisure", which was one of the main driving social forces in the Roman society, in spatial terms with reference to Roman domestic architecture. The study focuses on central Italy and particularly on Ephesus, the latter of which is a good example to discuss how the Roman conception of leisure was spatially materialized in a provincial private setting since a group of well studied, documented, and published houses constitute an appropriate comparative sample and context in Ephesus. The spatial organization and characteristics of the spaces housing leisurely activities are discussed on the basis of an "axes-scheme" that regulated and even dictated the visual and bodily interaction of the participants with certain spaces and elements during leisure activities either in a static state (sitting, reclining), or a kinetic one (walking, perambulating). The "visual axes" are those perceived in either of these states, along which the eye is directed towards a visual focal point, whereas the "dynamic axes" are those along which people move during a kinetic leisurely activity. The location, architecture, and use of leisure-oriented spaces in the Roman period houses in Ephesus, such as triclinium, exedra, oecus, museion, and peristyle courtyard are examined with reference to the proposed axes-scheme to present and compare the operation of leisure in the Roman provincial and private setting.
Hindawi Publishing Corporation
Case Reports in Medicine
Volume 2009, Article ID 738293, 3 pages
doi:10.1155/2009/738293
Case Report
Rituximab Efficacy during a Refractory Polyarteritis Nodosa Flare
Emmanuel Ribeiro,1 Thomas Cressend,1 Pierre Duffau,2 Marieke Grenouillet-Delacre,1
Marie Rouanet-Larivière,3 Anne Vital,4, 5 Maı̈té Longy-Boursier,1 and Patrick Mercié1
1 Service
de Médecine Interne, Hôpital Saint-André, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
de Médecine Interne et Maladies Infectieuses, Hôpital Haut-Lévêque, Centre Hospitalier Universitaire de Bordeaux,
Pessac, France
3 Service d’Exploration Fonctionnelle du Système Nerveux, Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux,
Bordeaux, France
4 Laboratoire d’Anatomo-Pathologie, Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
5 Université Victor-Segalen Bordeaux 2, 146, rue Léo-Saignant, 33076 Bordeaux Cedex, France
2 Service
Correspondence should be addressed to Patrick Mercié, [email protected]
Received 4 August 2009; Accepted 30 December 2009
Recommended by Kenneth C. Kalunian
Polyarteritis nodosa (PAN) is a systemic vasculitis whose severe forms are treated with glucocorticoids and cyclophosphamide.
Refractory patients are exposed to many complications, notably accelerated atherosclerosis. We report a case report of 71-yearold man followed for polyarteritis nodosa refractory to glucocorticoids and cyclosphosphamide. Systemic vasculitis relapses are
followed to accelerated atherosclerosis: severe ischemic lesions led to amputation of lower limbs. Remission of refractory PAN is
obtained with rituximab. Disappearance of biological inflammatory is allowed to regression of ischemic lesions in upper limbs. In
this situation, we recommend a systematic vascular work-up for patients suffered from refractory vasculitis. On the other hand,
therapeutic trials are needed to determine the real efficacy and place of rituximab in the treatment of polyarteritis nodosa.
Copyright © 2009 Emmanuel Ribeiro et al. This is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly
cited.
1. Presentation
Polyarteritis nodosa (PAN) is a systemic vasculitis of the
medium-sized vessels whose severe form, treated with glucocorticoids and cyclophosphamide, can give rise to late
complications, notably accelerated atherosclerosis, which
remains poorly described in this disease. Remission of
our patient’s severe PAN flare, refractory to conventional
treatment and complicated by accelerated atherosclerosis,
was obtained with rituximab.
2. Assessment
A 71-year-old man, with no remarkable medical history, had
been followed for 2 years for systemic vasculitis with successive flares manifested by polyarthritis, skin lesions, and bilateral orchitis associated with a biological inflammatory syndrome without immunological anomalies (no antinuclear
or antineutrophil cytoplasm antibodies (ANCAs) detected).
When a relapse occurred under glucocorticoids, intravenous
cyclophosphamide was started. After two cyclophosphamide
pulses, the patient’s condition deteriorated with subacute
polyarthritis, myalgias, livedo and acrocyanosis of the
four limbs. Signs of sensory-motor polyneuropathy were
observed on electromyograms of the legs. Histological
examination of a neuromuscular biopsy found vasculitis with
fibrinoid necrosis compatible with, confirming the diagnosis
of PAN (Figure 1).
Despite intravenous methylprednisolone, an acute coronary syndrome occurred with thrombosis of the right
coronary artery, followed by acute ischemia of the left leg.
Echo-Doppler ultrasonography detected occlusions of the
left anterior and posterior and the right posterior tibial
arteries. Echocardiography found no intracardiac thrombus. The persistent biological inflammatory syndrome (Creactive protein (CRP), 79 mg/L) raised the possible risk
of ischemic complications of the vasculitis in the legs. The
inefficacy of conventional therapy led to the prescription of
a weekly rituximab infusion (375 mg/m2 /week for 4 weeks).
The immediate worsening of the ischemic lesions, insensitive
2
Figure 1: Vasculitis of a muscle arteriole with fibrinoid necrosis
(magnification: ×250).
to all medical treatments, led to amputation of the lower left
leg. Histopathological examination of the surgical specimen
found atherosclerotic lesions in medium-sized vessels but
no signs of vasculitis or cholesterol emboli, leading us to
suspect accelerated atherosclerosis during a vasculitis flare
in this patient with no known history of cardiovascular or
atheromatous disease.
Rituximab was replaced by mycophenolate mofetil (1 g
twice daily) combined with glucocorticoids. The outcome
was favorable, with complete healing of the stump and rapid
regression of the biological inflammatory syndrome. He secondarily developed, independently of any signs of vasculitis,
a suprainfection of the big right toe that deteriorated rapidly.
Despite rituximab being effective, amputation of the second
lower leg was required.
The patient was again hospitalized 6 months later for
necrotic skin lesions on the fingers on the left hand accompanied by the reappearance of the biological inflammatory
syndrome (CRP, 58 mg/L). Echo-Doppler ultrasonography
and arteriography of the arms found atheromatous plaques
in the brachiocephalic trunk and occlusion of the left cubital
and right radial arteries.
The coexistence of medium-sized vessel lesions and
reappearance of the biological inflammatory syndrome led
us to suspect a PAN relapse. Rituximab (375 mg/m2 /week)
was administered for 4 weeks. Rapid and complete healing
of the digital ischemic lesions was observed with regression
of the biological inflammatory syndrome (erythrocyte sedimentation rate, 28 mm/1st h; CRP, 17 mg/L).
Rituximab was continued as maintenance therapy, with
a monthly infusion for 6 months followed by prolongation
of the interinfusion interval to 2 months. At present, after
2 years, the patient is asymptomatic, and no new ischemic
lesions have appeared. He continues to receive rituximab
every 3 months and his general condition is good.
3. Discussion
Rituximab is a chimeric monoclonal antibody that selectively
depletes CD20+ B lymphocytes. It is currently used to treat
Case Reports in Medicine
diverse autoimmune diseases and refractory vasculitides:
rheumatoid arthritis (RA), systemic lupus erythematosus
(SLE), Sjögren’s syndrome, ANCA-associated vasculitides,
mixed cryoglobulinemias, autoimmune cytopenias and neuropathies, myasthenia gravis, and bullous dermatoses [1].
Rituximab has also been successfully used to treat refractory
Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA) resistant to conventional regimens. Keogh et al.
reported obtaining remissions in their 10 WG and one MPA
patients with rituximab [2].
Two case reports have suggested that rituximab is also
effective against corticosteroid resistant polyarteritis nodosa
[3, 4]. This rituximab efficacy against systemic inflammatory
diseases led us to use this biologic twice to treat our
patient’s refractory PAN. It is difficult to explain the precise
role of rituximab in the first remission because of the
quasisimultaneous administration of cyclophosphamide and
methylprednisolone pulses. In contrast, the second remission
obtained with rituximab strongly suggests its efficacy at
controlling the vasculitis.
Improved survival of patients whose severe and progressing systemic vasculitides continue to progress under
maximal immunosuppressive therapy now enables us to
see late complications that have previously been poorly
described, notably the probable occurrence of accelerated
atherosclerosis.
Accelerated atherosclerosis has mainly been studied in
RA and SLE patients. Indeed, RA patients have suffered
excess mortality of cardiovascular origin, with standardized
all-cause-mortality ratios of 1.41 for women and 1.51 for
men, and respective cardiovascular values of 2.02 and 1.34
[5]. Indeed, 30% of SLE deaths are of cardiovascular origin
[6], with a relative risk of myocardial infarction multiplied
by 5 [7].
Unlike the autoimmune diseases addressed above, accelerated atherosclerosis in systemic vasculitides is rare, because
it has been less studied. After adjustment for cardiovascular
risk factors and CRP, it was recently demonstrated that
small-sized-vessel vasculitides were associated with a higher
frequency of subclinical atheromas [8]. Seyahi et al. [9]
showed that their 30 patients with Takayasu arteritis had a
significantly higher rate of subclinical atheromas than SLE
patients and the healthy controls (P < .001). In another study
on 29 WG patients, the intima-media thickness, a surrogate
marker of atherosclerosis, was significantly (P < .05) wider
compared to a group of controls with the same cardiovascular risk factors [10]. Concerning the pathophysiology
of these lesions, the diffuse endothelial dysfunction present
during the course of vasculitides [11] could facilitate the
rapid development of atherosclerosis.
Concerning our patient, distinguishing between accelerated atherosclerosis and the specific vasculitis involvement
was initially difficult. The histopathological examination of
the amputated limbs confirmed the existence of atherosclerotic lesions of medium-sized vessels with no sign of
associated PAN. It should be noted that the distribution of
atherosclerotic lesions affecting medium-sized vessels was
superimposable on the sites of predilection of inflammatory
PAN lesions.
Case Reports in Medicine
4. Conclusion
Among the new biotherapies potentially active against
vasculitides resistant to conventional treatment, rituximab
is given to treat severe, uncontrolled ANCA-associated
vasculitides but it could also have a role to play in refractory
PAN. Therapeutic trials are needed to determine the real
efficacy and place of rituximab in the treatment of PAN.
In these patients whose life expectancy can be prolonged
by these new therapeutic options, it is possible to observe,
during vasculitis flares, the appearance of potentially lifethreatening accelerated atherosclerosis. The chronic or acute
inflammation during vasculitis is probably a key element
in the progression of atheromatous disease [12]. In these
situations, it seems logical to recommend a systematic vascular work-up for patients with progressive and conventional
treatment-resistant vasculitides.
References
[1] J. Sibilia and C. Sordet, “Le rituximab: une biothérapie
originale dans les maladies auto-immunes,” Revue de Médecine
Interne, vol. 26, no. 61, pp. 485–500, 2005.
[2] K. A. Keogh, M. E. Wylam, J. H. Stone, and U. Specks,
“Induction of remission by B lymphocyte depletion in eleven
patients with refractory antineutrophil cytoplasmic antibodyassociated vasculitis,” Arthritis and Rheumatism, vol. 52, no. 1,
pp. 262–268, 2005.
[3] K. Sonomoto, T. Miyamura, H. Watanabe, et al., “A case of
polyarteritis nodosa successfully treated by rituximab,” Nihon
Rinsho Meneki Gakkai Kaishi, vol. 31, no. 2, pp. 119–123, 2008.
[4] D. Eleftheriou, M. Melo, S. D. Marks, et al., “Biologic therapy
in primary systemic vasculitis of the young,” Rheumatology,
vol. 48, no. 8, pp. 978–986, 2009.
[5] N. J. Goodson, N. J. Wiles, M. Lunt, E. M. Barrett, A. J. Silman,
and D. P. M. Symmons, “Mortality in early inflammatory polyarthritis: cardiovascular mortality is increased in seropositive
patients,” Arthritis and Rheumatism, vol. 46, no. 8, pp. 2010–
2019, 2002.
[6] C. Aranow and E. M. Ginzler, “Epidemiology of cardiovascular disease in systemic lupus erythematosus,” Lupus, vol. 9, no.
3, pp. 166–169, 2000.
[7] S. Manzi, E. N. Meilahn, J. E. Rairie, et al., “Age-specific
incidence rates of myocardial infarction and angina in women
with systemic lupus erythematosus: comparison with the
Framingham study,” American Journal of Epidemiology, vol.
145, no. 5, pp. 408–415, 1997.
[8] G. Chironi, C. Pagnoux, A. Simon, et al., “Increased prevalence of subclinical atherosclerosis in patients with smallvessel vasculitis,” Heart, vol. 93, no. 1, pp. 96–99, 2007.
[9] E. Seyahi, S. Ugurlu, R. Cumali, et al., “Atherosclerosis in
Takayasu arteritis,” Annals of the Rheumatic Diseases, vol. 65,
no. 9, pp. 1202–1207, 2006.
[10] K. De Leeuw, J. S. Sanders, C. Stegeman, A. Smit, C. G. Kallenberg, and M. Bijl, “Accelerated atherosclerosis in patients with
Wegener’s granulomatosis,” Annals of the Rheumatic Diseases,
vol. 64, no. 5, pp. 753–759, 2005.
[11] P. A. Bacon, “Endothelial cell dysfunction in systemic vasculitis: new developments and therapeutic prospects,” Current
Opinion in Rheumatology, vol. 17, no. 1, pp. 49–55, 2005.
[12] G. K. Hansson, “Mechanisms of disease: inflammation,
atherosclerosis, and coronary artery disease,” The New England
Journal of Medicine, vol. 352, no. 16, pp. 1685–1695, 2005.
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