Efficacy and safety of canakinumab in Schnitzler syndrome: A multicenter randomized placebo-controlled study

Journal of Allergy and Clinical Immunology

Volumn 139, Issue 4, 2017, Pages 1311-1320

  Krause, Karoline ^a   Tsianakas, Athanasios ^b   Wagner, Nicola ^c   Fischer, Jörg ^d   Weller, Karsten ^a   Metz, Martin ^a   Church, Martin K ^a   Maurer, Marcus ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^c KLINIKUM DARMSTADT   (Germany)

^d UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

Author keywords

Autoinflammatory; canakinumab; IL 1; Schnitzler syndrome; urticaria

Indexed keywords

C REACTIVE PROTEIN; CALGRANULIN C; CANAKINUMAB; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; IMMUNOGLOBULIN KAPPA CHAIN; IMMUNOGLOBULIN LAMBDA CHAIN; IMMUNOGLOBULIN M; INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; SERUM AMYLOID A; MONOCLONAL ANTIBODY;

ADULT; AGED; ARTHRALGIA; ARTICLE; ASTHMA; BODY WEIGHT DISORDER; BONE PAIN; CHILL; CLINICAL ARTICLE; CONTROLLED STUDY; DERMATOLOGY LIFE QUALITY INDEX; DISEASE ACTIVITY; DISEASE DURATION; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERTENSION; INJECTION SITE REACTION; MALE; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS INFECTION; MULTICENTER STUDY; MYALGIA; OPEN STUDY; OSTEOCHONDROSIS; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; QUALITY OF LIFE ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; SCHNITZLER SYNDROME; SHORT FORM 36; TREATMENT RESPONSE; URINARY TRACT INFECTION; URTICARIA; WEIGHT GAIN; CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; MIDDLE AGED; QUALITY OF LIFE; TREATMENT OUTCOME;

ADULT; AGED; ANTIBODIES, MONOCLONAL; C-REACTIVE PROTEIN; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; QUALITY OF LIFE; SCHNITZLER SYNDROME; SERUM AMYLOID A PROTEIN; TREATMENT OUTCOME;

EID: 85002849162     PISSN: 00916749     EISSN: 10976825     Source Type: Journal    
DOI: 10.1016/j.jaci.2016.07.041     Document Type: Article

References (32)

1. 1 Schnitzler, L., Lesions urticariennes chroniques permanentes (erytheme petaloıde?). Cas cliniques no.46B [Abstract] Journee Dermatologique d'Angers, 1972.
2. 2 Schnitzler, L.S.B., Boasson, M., Gardais, J., Tourmen, A., Urticaire chronique, lésions osseuses, macroglobulinémie IgM: maladie de Waldenström?. Bull Soc Fr Dermatol Syphiligr, 81, 1974, 363.
3. 3 de Koning, H.D., Bodar, E.J., van der Meer, J.W., Simon, A., Schnitzler Syndrome Study Group. Schnitzler syndrome: beyond the case reports: review and follow-up of 94 patients with an emphasis on prognosis and treatment. Semin Arthritis Rheum 37 (2007), 137–148.
4. 4 Simon, A., Asli, B., Braun-Falco, M., De Koning, H., Fermand, J.P., Grattan, C., et al. Schnitzler's syndrome: diagnosis, treatment, and follow-up. Allergy 68 (2013), 562–568.
5. 5 Lipsker, D., Veran, Y., Grunenberger, F., Cribier, B., Heid, E., Grosshans, E., The Schnitzler syndrome: four new cases and review of the literature. Medicine (Baltimore) 80 (2001), 37–44.
6. 6 de Koning, H.D., Schnitzler's syndrome: lessons from 281 cases. Clin Transl Allergy, 4, 2014, 41.
7. 7 Rizzi, R., Curci, P., Rinaldi, E., Rinaldi, F., Cimmino, A., Ricco, R., et al. Schnitzler's syndrome: monoclonal gammopathy associated with chronic urticaria. Acta Haematol 120 (2008), 1–4.
8. 8 Pizzirani, C., Falzoni, S., Govoni, M., La Corte, R., Donadei, S., Di Virgilio, F., et al. Dysfunctional inflammasome in Schnitzler's syndrome. Rheumatology (Oxford) 48 (2009), 1304–1308.
9. 9 Ryan, J.G., de Koning, H.D., Beck, L.A., Booty, M.G., Kastner, D.L., Simon, A., IL-1 blockade in Schnitzler syndrome: ex vivo findings correlate with clinical remission. J Allergy Clin Immunol 121 (2008), 260–262.
10. 10 Krause, K., Weller, K., Stefaniak, R., Wittkowski, H., Altrichter, S., Siebenhaar, F., et al. Efficacy and safety of the interleukin-1 antagonist rilonacept in Schnitzler syndrome: an open-label study. Allergy 67 (2012), 943–950.
11. 11 de Koning, H.D., Schalkwijk, J., van der Ven-Jongekrijg, J., Stoffels, M., van der Meer, J.W., Simon, A., Sustained efficacy of the monoclonal anti-interleukin-1 beta antibody canakinumab in a 9-month trial in Schnitzler's syndrome. Ann Rheum Dis 72 (2013), 1634–1638.
12. 12 Martinez-Taboada, V.M., Fontalba, A., Blanco, R., Fernandez-Luna, J.L., Successful treatment of refractory Schnitzler syndrome with anakinra: comment on the article by Hawkins et al. Arthritis Rheum 52 (2005), 2226–2227.
13. 13 Besada, E., Nossent, H., Dramatic response to IL1-RA treatment in longstanding multidrug resistant Schnitzler's syndrome: a case report and literature review. Clin Rheumatol 29 (2010), 567–571.
14. 14 Lachmann, H.J., Kone-Paut, I., Kuemmerle-Deschner, J.B., Leslie, K.S., Hachulla, E., Quartier, P., et al. Use of canakinumab in the cryopyrin-associated periodic syndrome. N Engl J Med 360 (2009), 2416–2425.
15. 15 Ruperto, N., Brunner, H.I., Quartier, P., Constantin, T., Wulffraat, N., Horneff, G., et al. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med 367 (2012), 2396–2406.
16. 16 Schlesinger, N., Alten, R.E., Bardin, T., Schumacher, H.R., Bloch, M., Gimona, A., et al. Canakinumab for acute gouty arthritis in patients with limited treatment options: results from two randomised, multicentre, active-controlled, double-blind trials and their initial extensions. Ann Rheum Dis 71 (2012), 1839–1848.
17. 17 Hoffman, H.M., Gregory, S.G., Mueller, J.L., Tresierras, M., Broide, D.H., Wanderer, A.A., et al. Fine structure mapping of CIAS1: identification of an ancestral haplotype and a common FCAS mutation, L353P. Hum Genet 112 (2003), 209–216.
18. 18 Lachmann, H.J., Goodman, H.J., Gilbertson, J.A., Gallimore, J.R., Sabin, C.A., Gillmore, J.D., et al. Natural history and outcome in systemic AA amyloidosis. N Engl J Med 356 (2007), 2361–2371.
19. 19 Kuemmerle-Deschner, J.B., Hachulla, E., Cartwright, R., Hawkins, P.N., Tran, T.A., Bader-Meunier, B., et al. Two-year results from an open-label, multicentre, phase III study evaluating the safety and efficacy of canakinumab in patients with cryopyrin-associated periodic syndrome across different severity phenotypes. Ann Rheum Dis 70 (2011), 2095–2102.
20. 20 Wittkowski, H., Kuemmerle-Deschner, J.B., Austermann, J., Holzinger, D., Goldbach-Mansky, R., Gramlich, K., et al. MRP8 and MRP14, phagocyte-specific danger signals, are sensitive biomarkers of disease activity in cryopyrin-associated periodic syndromes. Ann Rheum Dis 70 (2011), 2075–2081.
21. 21 Kallinich, T., Wittkowski, H., Keitzer, R., Roth, J., Foell, D., Neutrophil-derived S100A12 as novel biomarker of inflammation in familial Mediterranean fever. Ann Rheum Dis 69 (2010), 677–682.
22. 22 de Koning, H.D., Schalkwijk, J., Stoffels, M., Jongekrijg, J., Jacobs, J.F., Verwiel, E., et al. The role of interleukin-1 beta in the pathophysiology of Schnitzler's syndrome. Arthritis Res Ther, 17, 2015, 187.
23. 23 Wittkowski, H., Frosch, M., Wulffraat, N., Goldbach-Mansky, R., Kallinich, T., Kuemmerle-Deschner, J., et al. S100A12 is a novel molecular marker differentiating systemic-onset juvenile idiopathic arthritis from other causes of fever of unknown origin. Arthritis Rheum 58 (2008), 3924–3931.
24. 24 Yang, Z., Yan, W.X., Cai, H., Tedla, N., Armishaw, C., Di Girolamo, N., et al. S100A12 provokes mast cell activation: a potential amplification pathway in asthma and innate immunity. J Allergy Clin Immunol 119 (2007), 106–114.
25. 25 Nakamura, Y., Kambe, N., Saito, M., Nishikomori, R., Kim, Y.G., Murakami, M., et al. Mast cells mediate neutrophil recruitment and vascular leakage through the NLRP3 inflammasome in histamine-independent urticaria. J Exp Med 206 (2009), 1037–1046.
26. 26 de Koning, H.D., van Vlijmen-Willems, I.M., Rodijk-Olthuis, D., van der Meer, J.W., Zeeuwen, P.L., Simon, A., et al. Mast-cell interleukin-1beta, neutrophil interleukin-17 and epidermal antimicrobial proteins in the neutrophilic urticarial dermatosis in Schnitzler's syndrome. Br J Dermatol 173 (2015), 448–456.
27. 27 Launay, D., Dutoit-Lefevre, V., Faure, E., Robineau, O., Hauspie, C., Sobanski, V., et al. Effect of in vitro and in vivo anakinra on cytokines production in Schnitzler syndrome. PLoS One, 8, 2013, e59327.
28. 28 Lachmann, H.J., Lowe, P., Felix, S.D., Rordorf, C., Leslie, K., Madhoo, S., et al. In vivo regulation of interleukin 1beta in patients with cryopyrin-associated periodic syndromes. J Exp Med 206 (2009), 1029–1036.
29. 29 Lewis, V., Finlay, A.Y., 10 years experience of the Dermatology Life Quality Index (DLQI). J Investig Dermatol Symp Proc 9 (2004), 169–180.
30. 30 Krause, K., Mahamed, A., Weller, K., Metz, M., Zuberbier, T., Maurer, M., Efficacy and safety of canakinumab in urticarial vasculitis: an open-label study. J Allergy Clin Immunol 132 (2013), 751–754.e5.
31. 31 Neel, A., Henry, B., Barbarot, S., Masseau, A., Perrin, F., Bernier, C., et al. Long-term effectiveness and safety of interleukin-1 receptor antagonist (anakinra) in Schnitzler's syndrome: a French multicenter study. Autoimmun Rev 13 (2014), 1035–1041.
32. 32 Dinarello, C.A., Simon, A., van der Meer, J.W., Treating inflammation by blocking interleukin-1 in a broad spectrum of diseases. Nat Rev Drug Discov 11 (2012), 633–652.