, ANNEXE, vol.5

, Patiente(e) au calme, à jeun depuis 12 heures, ayant eu les investigations nécessaires avant de proposer ce traitement

, Patiente(e) averti(e) des objectifs, modalités et risques du traitement Commande et vérification au préalable

, Vérification du chariot de réanimation et de la présence de deux ampoules, au moins, d'ADRENALINE

, Vérification de la disponibilité d'un appareil de monitoring

, Préparer le matériel de perfusion et d'administration de RITUXIMAB R

, Préparer le bolus de SOLUMEDROL R de 100 mg, l'injection de POLARAMINE R , la perfusion de PERFALFAN

T. Chronologie-du,

, Mise en place d'une VVP

, Mise en place d'une surveillance ECG (monitoring) et tension artérielle

L. Bartalena, Graves' orbitopathy: imperfect treatments for a rare disease, Eur Thyroid J, vol.2, pp.259-269, 2013.

P. Perros, L. Hegedüs, and L. Bartalena, Graves' orbitopathy as a rare disease in Europe: a European Group on Graves' Orbitopathy (EUGOGO) position statement, Orphanet J Rare Dis, vol.12, p.72, 2017.

R. Bahn, Current Insights into the Pathogenesis of Graves' Ophthalmopathy, Hormone and Metabolic Research, vol.47, pp.773-778, 2015.

L. Bartalena, L. Baldeschi, and K. Boboridis, European Thyroid Association/European Group on Graves' Orbitopathy Guidelines for the Management of Graves' Orbitopathy, Eur Thyroid J, vol.5, pp.9-26, 2016.

H. Stiebel-kalish, E. Robenshtok, and M. Hasanreisoglu, Treatment Modalities for Graves' Ophthalmopathy: Systematic Review and Metaanalysis, The Journal of Clinical Endocrinology & Metabolism, vol.94, pp.2708-2716, 2009.

S. Zang, K. A. Ponto, and G. J. Kahaly, Intravenous Glucocorticoids for Graves' Orbitopathy: Efficacy and Morbidity, The Journal of Clinical Endocrinology & Metabolism, vol.96, pp.320-332, 2011.

L. Bartalena, G. E. Krassas, and W. Wiersinga, Efficacy and Safety of Three Different Cumulative Doses of Intravenous Methylprednisolone for Moderate to Severe and Active Graves, Orbitopathy. The Journal of Clinical Endocrinology & Metabolism, vol.97, pp.4454-4463, 2012.

G. J. Kahaly, S. Pitz, and G. Hommel, Single Blind Trial of Intravenous versus Oral Steroid Monotherapy in Graves, Orbitopathy. The Journal of Clinical Endocrinology & Metabolism, vol.90, pp.5234-5240, 2005.

R. J. Van-geest, I. V. Sasim, and H. Koppeschaar, Methylprednisolone pulse therapy for patients with moderately severe Graves' orbitopathy: a prospective, randomized, placebo-controlled study, European Journal of Endocrinology, vol.158, pp.229-237, 2008.

S. Estcourt, J. Hickey, and P. Perros, The patient experience of services for thyroid eye disease in the United Kingdom: results of a nationwide survey, Eur J Endocrinol, vol.161, pp.483-487, 2009.

L. Bartalena, What to do for moderate-to-severe and active Graves' orbitopathy if glucocorticoids fail?, Clin Endocrinol (Oxf), vol.73, pp.149-152, 2010.

M. F. Prummel, M. P. Mourits, and A. Berghout, Prednisone and cyclosporine in the treatment of severe Graves' ophthalmopathy, N Engl J Med, vol.321, pp.1353-1359, 1989.

G. Kahaly, J. Schrezenmeir, and U. Krause, Ciclosporin and prednisone v. prednisone in treatment of Graves' ophthalmopathy: a controlled, randomized and prospective study, Eur J Clin Invest, vol.16, pp.415-422, 1986.

C. Marcocci, L. Bartalena, and F. Bogazzi, Orbital radiotherapy combined with high dose systemic glucocorticoids for Graves' ophthalmopathy is more effective than radiotherapy alone: results of a prospective randomized study, J Endocrinol Invest, vol.14, pp.853-860, 1991.

L. Bartalena, C. Marcocci, and M. L. Tanda, Orbital radiotherapy for Graves' ophthalmopathy, Thyroid, vol.12, pp.245-250, 2002.

I. S. Miguel, M. Arenas, and R. Carmona, Review of the treatment of Graves' ophthalmopathy: The role of the new radiation techniques, Saudi Journal of Ophthalmology, vol.32, p.139, 2018.

S. S. Donaldson, M. A. Bagshaw, and J. P. Kriss, Supervoltage orbital radiotherapy for Graves' ophthalmopathy, J Clin Endocrinol Metab, vol.37, pp.276-285, 1973.

M. Salvi, G. Vannucchi, and N. Currò, Efficacy of B-cell targeted therapy with rituximab in patients with active moderate to severe Graves' orbitopathy: a randomized controlled study, J Clin Endocrinol Metab, vol.100, pp.422-431, 2015.

D. E. Fassi, C. H. Nielsen, and H. C. Hasselbalch, Treatment-Resistant Severe, Active Graves' Ophthalmopathy Successfully Treated with B Lymphocyte Depletion, Thyroid, vol.16, pp.709-710, 2006.

M. Salvi, G. Vannucchi, and I. Campi, Treatment of Graves' disease and associated ophthalmopathy with the anti-CD20 monoclonal antibody rituximab: an open study, European Journal of Endocrinology, vol.156, pp.33-40, 2007.

M. Salvi, Small Dose of Rituximab for Graves Orbitopathy: New Insights Into the Mechanism of Action, Archives of Ophthalmology, vol.130, p.122, 2012.

M. Salvi, G. Vannucchi, and I. Campi, Efficacy of rituximab treatment for thyroid-associated ophthalmopathy as a result of intraorbital B-cell depletion in one patient unresponsive to steroid immunosuppression, Eur J Endocrinol, vol.154, pp.511-517, 2006.

D. Khanna, K. Chong, and N. F. Afifiyan, Rituximab treatment of patients with severe, corticosteroidresistant thyroid-associated ophthalmopathy, Ophthalmology, vol.117, p.133, 2010.

S. Madaschi, A. Rossini, and I. Formenti, Treatment of Thyroid-Associated Orbitopathy with Rituximab-A Novel Therapy for an Old Disease: Case Report and Literature Review, Endocrine Practice, vol.16, pp.677-685, 2010.

R. Z. Silkiss, A. Reier, and M. Coleman, Rituximab for Thyroid Eye Disease: Ophthalmic Plastic &, Reconstructive Surgery, vol.26, pp.310-314, 2010.

A. L. Mitchell, E. H. Gan, and M. Morris, The effect of B cell depletion therapy on anti-TSH receptor antibodies and clinical outcome in glucocorticoid-refractory Graves' orbitopathy, Clinical Endocrinology, vol.79, pp.437-442, 2013.

A. N. Mccoy, D. S. Kim, and E. F. Gillespie, Rituximab (Rituxan) Therapy for Severe Thyroid-Associated Ophthalmopathy Diminishes IGF-1R

. +-t-cells, The Journal of Clinical Endocrinology & Metabolism, vol.99, pp.1294-1299, 2014.

A. Erdei, G. Paragh, and P. Kovacs, Rapid response to and long-term effectiveness of anti-CD20 antibody in conventional therapy resistant Graves' orbitopathy: A five-year follow-up study, Autoimmunity, vol.47, pp.548-555, 2014.

J. Li, Z. Xiao, and X. Hu, The Efficacy of Rituximab Combined with 131I for Ophthalmic Outcomes of Graves' Ophthalmopathy Patients, Pharmacology, vol.99, pp.144-152, 2017.

D. Karasek, L. Cibickova, and M. Karhanova, Clinical and immunological changes in patients with active moderate-to-severe Graves? orbitopathy treated with very low-dose rituximab, Endokrynol Pol. Epub, 2017.

F. Précausta, S. Arsène, and P. Renoult-pierre, Treatment by rituximab on six Grave's ophthalmopathies resistant to corticosteroids, Annales d'Endocrinologie, vol.78, pp.20-26, 2017.

T. ?im?ek, N. Y?ld?r?m, and B. Efe, Rituximab Treatment in a Patient with Active Graves' Orbitopathy and Psoriasis, Türk Oftalmoloji Dergisi, vol.47, pp.42-46, 2017.

M. N. Stan, J. A. Garrity, C. Leon, and B. G. , Randomized controlled trial of rituximab in patients with Graves' orbitopathy, J Clin Endocrinol Metab, vol.100, pp.432-441, 2015.

G. E. Krassas, A. Stafilidou, and K. G. Boboridis, Failure of rituximab treatment in a case of severe thyroid ophthalmopathy unresponsive to steroids, Clin Endocrinol (Oxf), vol.72, pp.853-855, 2010.

A. J. Gess and R. Z. Silkiss, Orbital B-Lymphocyte Depletion in a Treatment Failure of Rituximab for Thyroid Eye Disease, Ophthalmic Plastic and Reconstructive Surgery, vol.30, pp.11-13, 2014.

M. P. Mourits, L. Koornneef, and W. M. Wiersinga, Clinical criteria for the assessment of disease activity in Graves' ophthalmopathy: a novel approach, Br J Ophthalmol, vol.73, pp.639-644, 1989.

G. B. Bartley, V. Fatourechi, and E. F. Kadrmas, The incidence of Graves' ophthalmopathy in Olmsted County, Minnesota, Am J Ophthalmol, vol.120, pp.511-517, 1995.

F. F. Rundle, Management of exophthalmos and related ocular changes in Graves' disease, Metab Clin Exp, vol.6, pp.36-48, 1957.

M. E. Reff, K. Carner, and K. S. Chambers, Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20, Blood, vol.83, pp.435-445, 1994.

, Mabthera resume caratérsitique du produit, p.26, 2017.

-. Mabthera_pic_ei_vascularite_avis2_ct13904, , p.26, 2017.

, Anticorps monoclonal anti-CD20 et traitement des maladies auto-immunes, p.24, 2017.

J. Edwards, L. Szczepanski, and J. Szechinski, Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis, N Engl J Med, vol.350, pp.2572-2581, 2004.

H. C. Hasselbalch, B-cell depletion with rituximab-a targeted therapy for Graves' disease and autoimmune thyroiditis, Immunology Letters, vol.88, pp.85-86, 2003.

C. Segundo, C. Rodríguez, and A. García-poley, Thyroid-infiltrating B lymphocytes in Graves' disease are related to marginal zone and memory B cell compartments, Thyroid, vol.11, pp.525-530, 2001.

M. N. Stan, M. Salvi, . Management, and . Endocrine-disease, Rituximab therapy for Graves' orbitopathy -lessons from randomized control trials, Eur J Endocrinol, vol.176, pp.101-109, 2017.

I. Campi, G. Vannucchi, M. Salvi, . Therapy, and . Endocrine-disease, Endocrine dilemma: management of Graves' orbitopathy, Eur J Endocrinol, vol.175, pp.117-133, 2016.

C. Marcocci, L. Bartalena, and F. Bogazzi, Studies on the occurrence of ophthalmopathy in Graves' disease, Acta Endocrinol, vol.120, pp.473-478, 1989.

P. Perros, A. L. Crombie, and J. Matthews, Age and gender influence the severity of thyroid-associated ophthalmopathy: a study of 101 patients attending a combined thyroid-eye clinic, Clinical Endocrinology, vol.38, pp.367-372, 1993.

F. Menconi, M. Leo, and P. Vitti, Total thyroid ablation in Graves' orbitopathy, J Endocrinol Invest, vol.38, pp.809-815, 2015.

J. Järhult, C. Rudberg, and E. Larsson, Disease with Moderate-Severe Endocrine Ophthalmopathy-Long Term Results of a Prospective, Randomized Study of Total or Subtotal Thyroid Resection, Thyroid, vol.15, pp.1157-1164, 2005.

Y. Abe, H. Sato, and M. Noguchi, Effect of subtotal thyroidectomy on natural history of ophthalmopathy in Graves' disease, World J Surg, vol.22, pp.714-717, 1998.

C. Marcocci, G. Bruno-bossio, and L. Manetti, The course of Graves' ophthalmopathy is not influenced by near total thyroidectomy: a case-control study, Clin Endocrinol (Oxf), vol.51, pp.503-508, 1999.

S. C. Werner, C. R. Feind, and A. M. , Progression of severe eye changes and decrease in serum long acting thyroid stimulator after operation, N Engl J Med, vol.276, pp.132-138, 1967.

Z. W. Liu, L. Masterson, and B. Fish, Thyroid surgery for Graves' disease and Graves' ophthalmopathy, Cochrane Database Syst Rev, 2015.

A. Pasquereau, . La, . De, and . France, PREMIERS RÉSULTATS DU BAROMÈTRE SANTÉ 2017 / TOBACCO CONSUMPTION IN FRANCE: PRELIMINARY RESULTS FROM THE 2017 HEALTH BAROMETER. 9

A. Khan, D. L. Scott, and M. Batley, Smoking, rheumatoid factor status and responses to rituximab, Annals of the Rheumatic Diseases, vol.71, pp.1587-1588, 2012.

T. J. Cawood, P. Moriarty, and C. O'farrelly, Smoking and Thyroid-Associated Ophthalmopathy: A Novel Explanation of the Biological Link, The Journal of Clinical Endocrinology & Metabolism, vol.92, pp.59-64, 2007.

P. Perros, A. L. Crombie, K. , and P. , Natural history of thyroid associated ophthalmopathy, Clin Endocrinol (Oxf), vol.42, pp.45-50, 1995.

J. V. Perez-moreiras, J. J. Gomez-reino, and J. R. Maneiro, Efficacy of tocilizumab in patients with moderate to severe corticosteroid resistant Graves´ orbitopathy: A randomized clinical trial, American Journal of Ophthalmology. Epub, 2018.

T. J. Smith, G. J. Kahaly, and D. G. Ezra, Teprotumumab for Thyroid-Associated Ophthalmopathy, N Engl J Med, vol.376, pp.1748-1761, 2017.

J. V. Pérez-moreiras, A. Alvarez-lópez, and E. C. Gómez, Treatment of active corticosteroid-resistant graves' orbitopathy, Ophthal Plast Reconstr Surg, vol.30, pp.162-167, 2014.

G. Savino, L. Balia, and D. Colucci, Intraorbital injection of rituximab: a new approach for active thyroid-associated orbitopathy, a prospective case series, Minerva Endocrinol, vol.38, pp.173-179, 2013.

M. Zakarija and J. M. Mckenzie, The spectrum and significance of autoantibodies reacting with the thyrotropin receptor, Endocrinol Metab Clin North Am, vol.16, pp.343-363, 1987.

V. Michelangeli, C. Poon, and J. Taft, The prognostic value of thyrotropin receptor antibody measurement in the early stages of treatment of Graves' disease with antithyroid drugs, Thyroid, vol.8, pp.119-124, 1998.

G. Vannucchi, I. Campi, and M. Bonomi, Rituximab treatment in patients with active Graves' orbitopathy: effects on proinflammatory and humoral immune reactions, Clin Exp Immunol, vol.161, pp.436-443, 2010.

A. L. Mitchell, E. H. Gan, and M. Morris, The effect of B cell depletion therapy on anti-TSH receptor antibodies and clinical outcome in glucocorticoid-refractory Graves' orbitopathy, Clin Endocrinol (Oxf), vol.79, pp.437-442, 2013.

C. Josseaume and Y. Lorcy,

, Ann Endocrinol (Paris), vol.69, issue.1, pp.29-32, 2008.

M. Salvi, . Md, L. R. Pasquale, and T. C. Chen, Small Dose of Rituximab for Graves Orbitopathy: New Insights Into the Mechanism of Action, Archives of Ophthalmology, vol.130, pp.120-122, 2012.

M. Salvi, G. Vannucchi, and I. Campi, Treatment of Graves' disease and associated ophthalmopathy with the anti-CD20 monoclonal antibody rituximab: an open study, Eur J Endocrinol, vol.156, pp.33-40, 2007.

R. F. Van-vollenhoven, P. Emery, and C. O. Bingham, Longterm safety of patients receiving rituximab in rheumatoid arthritis clinical trials, J Rheumatol, vol.37, pp.558-567, 2010.

M. Salvi, G. Vannucchi, and I. Campi, Rituximab treatment in a patient with severe thyroid-associated ophthalmopathy: effects on orbital lymphocytic infiltrates, Clin Immunol, vol.131, pp.360-365, 2009.

R. S. Bahn, . Pathophysiology, and . Graves, Ophthalmopathy: The Cycle of Disease, The Journal of Clinical Endocrinology & Metabolism, vol.88, pp.1939-1946, 2003.

R. W. Valyasevi, D. A. Harteneck, and C. M. Dutton, Stimulation of adipogenesis, peroxisome proliferatoractivated receptor-gamma (PPARgamma), and thyrotropin receptor by PPARgamma agonist in human orbital preadipocyte fibroblasts, J Clin Endocrinol Metab, vol.87, pp.2352-2358, 2002.

H. J. Cao, H. S. Wang, and Y. Zhang, Activation of human orbital fibroblasts through CD40 engagement results in a dramatic induction of hyaluronan synthesis and prostaglandin endoperoxide H synthase-2 expression. Insights into potential pathogenic mechanisms of thyroid-associated ophthalmopathy, J Biol Chem, vol.273, pp.29615-29625, 1998.

T. J. Hufnagel, W. F. Hickey, and W. H. Cobbs, Immunohistochemical and ultrastructural studies on the exenterated orbital tissues of a patient with Graves' disease, Ophthalmology, vol.91, pp.1411-1419, 1984.

A. K. Eckstein, B. Quadbeck, and S. Tews, Thyroid associated ophthalmopathy: evidence for CD4(+) gammadelta T cells; de novo differentiation of RFD7(+) macrophages, but not of RFD1(+) dendritic cells; and loss of gammadelta and alphabeta T cell receptor expression, Br J Ophthalmol, vol.88, pp.803-808, 2004.

A. Pappa, J. M. Lawson, and V. Calder, T cells and fibroblasts in affected extraocular muscles in early and late thyroid associated ophthalmopathy, Br J Ophthalmol, vol.84, pp.517-522, 2000.

N. Villamor, E. Montserrat, and D. Colomer, Mechanism of action and resistance to monoclonal antibody therapy, Semin Oncol, vol.30, pp.424-433, 2003.

G. C. Tsokos, B cells, be gone--B-cell depletion in the treatment of rheumatoid arthritis, N Engl J Med, vol.350, pp.2546-2548, 2004.

A. Ahuja, S. M. Anderson, and A. Khalil, Maintenance of the plasma cell pool is independent of memory B cells, Proc Natl Acad Sci U S A, vol.105, pp.4802-4807, 2008.

M. Salvi, Immunotherapy for Graves' ophthalmopathy, Curr Opin Endocrinol Diabetes Obes, vol.21, pp.409-414, 2014.

M. H. Buch, J. S. Smolen, and N. Betteridge, Updated consensus statement on the use of rituximab in patients with rheumatoid arthritis, Annals of the Rheumatic Diseases, vol.70, pp.909-920, 2011.

S. B. Cohen, P. Emery, and M. W. Greenwald, Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks, Arthritis Rheum, vol.54, pp.2793-2806, 2006.

P. Emery, R. Fleischmann, and A. Filipowicz-sosnowska, The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial, Arthritis Rheum, vol.54, pp.1390-1400, 2006.

S. Shetty and A. R. Ahmed, Preliminary analysis of mortality associated with rituximab use in autoimmune diseases, Autoimmunity, vol.46, pp.487-496, 2013.

L. C. Lands, New therapies, new concerns: rituximab-associated lung injury, Pediatr Nephrol, vol.25, pp.1001-1003, 2010.

S. A. Wagner, A. C. Mehta, and D. A. Laber, Rituximab-induced interstitial lung disease, Am J Hematol, vol.82, pp.916-919, 2007.

V. Garypidou, V. Perifanis, and K. Tziomalos, Cardiac toxicity during rituximab administration, Leuk Lymphoma, vol.45, pp.203-204, 2004.

J. D. Armitage, C. Montero, and A. Benner, Acute coronary syndromes complicating the first infusion of rituximab, Clin Lymphoma Myeloma, vol.8, pp.253-255, 2008.

D. Mabrouk, H. M. Gürcan, and D. B. Keskin, Association between cancer and immunosuppressive therapy--analysis of selected studies in pemphigus and pemphigoid, Ann Pharmacother, vol.44, pp.1770-1776, 2010.

. Le-serment-d'hippocrate,

, Au moment d'être admis à exercer la médecine, je promets et je jure d'être fidèle aux lois de l'honneur et de la probité

, Mon premier souci sera de rétablir, de préserver ou de promouvoir la santé dans tous ses éléments, physiques et mentaux, individuels et sociaux

, Je respecterai toutes les personnes, leur autonomie et leur volonté, sans aucune discrimination selon leur état ou leurs convictions. J'interviendrai pour les protéger si elles sont affaiblies, vulnérables ou menacées dans leur intégrité ou leur dignité. Même sous la contrainte

, J'informerai les patients des décisions envisagées, de leurs raisons et de leurs

, Reçu à l'intérieur des maisons, je respecterai les secrets des foyers et ma conduite ne servira pas à corrompre les moeurs

, Je ne prolongerai pas abusivement les agonies. Je ne provoquerai jamais la mort délibérément

, Je n'entreprendrai rien qui dépasse mes compétences. Je les entretiendrai et les perfectionnerai pour assurer au mieux les services qui me seront demandés

, J'apporterai mon aide à mes confrères ainsi qu'à leurs familles dans l'adversité.Que les hommes et mes confrères m'accordent leur estime si je suis fidèle à mes promesses