Rituximab as second-line treatment for adult immune thrombocytopenia (the RITP trial): A multicentre, randomised, double-blind, placebo-controlled trial

The Lancet

Volumn 385, Issue 9978, 2015, Pages 1653-1661

  Ghanima, Waleed ^a,f   Khelif, Abderrahim ^b   Waage, Anders ^c   Michel, Marc ^d   Tjønnford, Geir E ^f   Romdhan, Neila Ben ^e   Kahrs, Johannes ^a   Darne, Bernadette ^g   Holme, Pål Andrè ^f  

^a Ostfold Hospital Trust   (Norway)

^b FARHAT HACHED HOSPITAL   (Tunisia)

^c TRONDHEIM UNIVERSITY HOSPITAL   (Norway)

^d HENRI MONDOR HOSPITAL   (France)

^e LA RABTA HOSPITAL   (Tunisia)

^f OSLO UNIVERSITY HOSPITAL   (Norway)

^g Monitoring Force Group   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; IMMUNOGLOBULIN; PLACEBO; RITUXIMAB; IMMUNOLOGIC FACTOR; MONOCLONAL ANTIBODY;

ABDOMINAL PAIN; ADULT; ADULT DISEASE; ADULT IMMUNE THROMBOCYTOPENIA; ANEMIA; APPENDICITIS; ARTICLE; BACKACHE; BLEEDING; BRONCHITIS; CONTROLLED STUDY; COUGHING; DEEP VEIN THROMBOSIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; FEMALE; FEVER; HUMAN; INCIDENCE; INFLUENZA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OVARY CYST; PELVIC PAIN; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RECURRENCE RISK; RELAPSE; SPLENECTOMY; THROAT IRRITATION; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TREATMENT FAILURE; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VENOUS THROMBOEMBOLISM; CLINICAL TRIAL; MIDDLE AGED; OFF LABEL DRUG USE; PURPURA, THROMBOCYTOPENIC, IDIOPATHIC; RECURRENT DISEASE;

ADRENAL CORTEX HORMONES; ADULT; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; HUMANS; IMMUNOLOGIC FACTORS; MIDDLE AGED; OFF-LABEL USE; PURPURA, THROMBOCYTOPENIC, IDIOPATHIC; RECURRENCE; TREATMENT FAILURE;

EID: 84933279873     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(14)61495-1     Document Type: Article

References (24)

1. Cines DB, Bussel JB, Liebman HA, Luning Prak ET. The ITP syndrome: pathogenic and clinical diversity. Blood 2009; 113: 6511-21.
2. Provan D, Stasi R, Newland AC, et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood 2010; 115: 168-86.
3. Neunert C, Lim W, Crowther M, and the American Society of Hematology. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood 2011; 117: 4190-207.
4. Cheng Y, Wong RS, Soo YO, et al. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med 2003; 349: 831-36.
5. Sailer T, Lechner K, Panzer S, Kyrle PA, Pabinger I. The course of severe autoimmune thrombocytopenia in patients not undergoing splenectomy. Haematologica 2006; 91: 1041-45.
6. Portielje JE, Westendorp RG, Kluin-Nelemans HC, Brand A. Morbidity and mortality in adults with idiopathic thrombocytopenic purpura. Blood 2001; 97: 2549-54.
7. Kojouri K, Vesely SK, Terrell DR, George JN. Splenectomy for adult patients with idiopathic thrombocytopenic purpura: a systematic review to assess long-term platelet count responses, prediction of response, and surgical complications. Blood 2004; 104: 2623-34.
8. Kristinsson SY, Gridley G, Hoover RN, Check D, Landgren O. Long-term risks after splenectomy among 8 149 cancer-free American veterans: a cohort study with up to 27 years follow-up. Haematologica 2014; 99: 392-98.
9. Ghanima W, Godeau B, Cines DB, Bussel JB. How I treat immune thrombocytopenia: the choice between splenectomy or a medical therapy as a second-line treatment. Blood 2012; 120: 960-69.
10. George JN, Woolf SH, Raskob GE, et al. Idiopathic thrombocytopenic purpura: a practice guideline developed by explicit methods for the American Society of Hematology. Blood 1996; 88: 3-40.
11. Rodeghiero F, Ruggeri M. Is splenectomy still the gold standard for the treatment of chronic ITP? Am J Hematol 2008; 83: 91.
12. Arnold DM, Dentali F, Crowther MA, et al. Systematic review: efficacy and safety of rituximab for adults with idiopathic thrombocytopenic purpura. Ann Intern Med 2007; 146: 25-33.
13. Patel VL, Mahévas M, Lee SY, et al. Outcomes 5 years after response to rituximab therapy in children and adults with immune thrombocytopenia. Blood 2012; 119: 5989-95.
14. Cooper N, Stasi R, Cunningham-Rundles S, et al. The efficacy and safety of B-cell depletion with anti-CD20 monoclonal antibody in adults with chronic immune thrombocytopenic purpura. Br J Haematol 2004; 125: 232-39.
15. Health UNCIo. Common Terminology Criteria for Adverse Events v3.0 2006. http://ctep.cancer.gov/protocoldevelopment/electronic-applications/docs/ctcaev3.pdf2006 (accessed Feb 20, 2014).
16. Khellaf M, Michel M, Schaeffer A, Bierling P, Godeau B. Assessment of a therapeutic strategy for adults with severe autoimmune thrombocytopenic purpura based on a bleeding score rather than platelet count. Haematologica 2005; 90: 829-32.
17. Zaja F, Baccarani M, Mazza P, et al. Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia. Blood 2010; 115: 2755-62.
18. Gudbrandsdottir S, Birgens HS, Frederiksen H, et al. Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia. Blood 2013; 121: 1976-81.
19. Arnold DM, Heddle NM, Carruthers J, et al. A pilot randomized trial of adjuvant rituximab or placebo for nonsplenectomized patients with immune thrombocytopenia. Blood 2012; 119: 1356-62.
20. Li Z, Mou W, Lu G, et al. Low-dose rituximab combined with short-term glucocorticoids up-regulates Treg cell levels in patients with immune thrombocytopenia. Int J Hematol 2011; 93: 91-98.
21. Neylon AJ, Saunders PW, Howard MR, Proctor SJ, Taylor PR, and the Northern Region Haematology Group. Clinically significant newly presenting autoimmune thrombocytopenic purpura in adults: a prospective study of a population-based cohort of 245 patients. Br J Haematol 2003; 122: 966-74.
22. Mazzucconi MG, Fazi P, Bernasconi S, et al, and the Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Thrombocytopenia Working Party. Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood 2007; 109: 1401-07.
23. Bussel JB, Lee CS, Seery C, et al. Rituximab and 3 dexamethasone cycles provide responses similar to splenectomy in women and those with immune thrombocytopenia less than 2 years duration. Haematologica 2014; 99: 1264-71.
24. Zaja F, Vianelli N, Battista M, et al. Earlier administration of rituximab allows higher rate of long-lasting response in adult patients with autoimmune thrombocytopenia. Exp Hematol 2006; 34: 571-72.