Use of case reports and the Adverse Event Reporting System in systematic reviews: overcoming barriers to assess the link between Crohn’s disease medications and hepatosplenic T-cell lymphoma
Tóm tắt
To identify demographic and clinical characteristics associated with cases of hepatosplenic T-cell lymphoma (HSTCL) in patients with Crohn’s disease, and to assess strength of evidence for a causal relationship between medications and HSTCL in Crohn’s disease. We identified cases of HSTCL in Crohn’s disease in studies included in a comparative effectiveness review of Crohn’s disease medications, through a separate search of PubMed and Embase for published case reports, and from the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS). We used three causality assessment tools to evaluate the relationship between medication exposure and HSTCL. We found 37 unique cases of HSTCL in patients with Crohn’s disease. Six cases were unique to the published literature and nine were unique to AERS. Cases were typically young (<40 years of age) and male (86%). The most commonly reported medications were anti-metabolites (97%) and anti-tumor necrosis factor alpha (anti-TNFa) medications (76%). Dose and duration of therapy were not consistently reported. Use of aminosalicylates and corticosteroids were rarely reported, despite the high prevalence of these medications in routine treatment. Using the causality assessment tools, it could only be determined that anti-metabolite and anti-TNFa therapies were possible causes of HSTCL in Crohn’s disease based on the data contained in the case reports. Systematic reviews that incorporate case reports of rare lethal events should search both published literature and AERS, but consideration should be given to the limitations of case reports. In this study, establishing a causative effect other than ‘possible’ between anti-metabolite or anti-TNFa therapies and HSTCL was not feasible because case reports lacked data required by the causality assessments, and because of the limited applicability of causality assessment tools for rare irreversible events. We recommend minimum reporting requirements for case reports to improve causality assessment and routine reporting of rare life-threatening events, including their absence, in clinical trials to help clinicians determine whether rare adverse events are causally related to a medication.
Tài liệu tham khảo
Talley NJ, Abreu MT, Achkar JP, Bernstein CN, Dubinsky MC, Hanauer SB, Kane SV, Sandborn WJ, Ullman TA, Moayyedi P: An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011, 106 (Suppl 1): 2-25. quiz S26
Korelitz BI, Present DH: A history of immunosuppressive drugs in the treatment of inflammatory bowel disease: origins at the Mount Sinai Hospital. Mt Sinai J Med. 1996, 63: 191-201.
Janssen Biotech, Inc: Highlights of prescribing information: Remicade (infliximab). 2011, Horsham, PA: Janssen Biotech, Inc,http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5295lbl.pdf,
Armitage JO: The aggressive peripheral T-cell lymphomas: 2012 update on diagnosis, risk stratification, and management. Am J Hematol. 2012, 87: 511-519. 10.1002/ajh.23144.
Falchook GS, Vega F, Dang NH, Samaniego F, Rodriguez MA, Champlin RE, Hosing C, Verstovsek S, Pro B: Hepatosplenic gamma-delta T-cell lymphoma: clinicopathological features and treatment. Ann Oncol. 2009, 20: 1080-1085. 10.1093/annonc/mdn751.
Effective Health Care Program: Comparative effectiveness of pharmacologic therapies for the management of Crohn's disease. 2010, Rockville, MD: Agency for Healthcare Research and Quality,http://effectivehealthcare.ahrq.gov/ehc/products/192/515/Crohns%20Protocol%2081%2026%2010.pdf,
Poluzzi E, Raschi E, Moretti U, De Ponti F: Drug-induced torsades de pointes: data mining of the public version of the FDA Adverse Event Reporting System (AERS). Pharmacoepidemiol Drug Saf. 2009, 18: 512-518. 10.1002/pds.1746.
Uppsala Monitoring Centre: The use of the WHO-UMC system for standardised case causality assessment. Uppsala: Uppsala Monitoring Centre,http://who-umc.org/Graphics/24734.pdf,
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ: A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981, 30: 239-245. 10.1038/clpt.1981.154.
Kramer MS, Leventhal JM, Hutchinson TA, Feinstein AR: An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use. JAMA. 1979, 242: 623-632. 10.1001/jama.1979.03300070019017.
Navarro JT, Ribera JM, Mate JL, Granada I, Junca J, Batlle M, Milla F, Feliu E: Hepatosplenic T-gammadelta lymphoma in a patient with Crohn's disease treated with azathioprine. Leuk Lymphoma. 2003, 44: 531-533. 10.1080/1042819021000035662.
Thayu M, Markowitz JE, Mamula P, Russo PA, Muinos WI, Baldassano RN: Hepatosplenic T-cell lymphoma in an adolescent patient after immunomodulator and biologic therapy for Crohn disease. J Pediatr Gastroenterol Nutr. 2005, 40: 220-222. 10.1097/00005176-200502000-00026.
Kotlyar DS, Blonski W, Diamond RH, Wasik M, Lichtenstein GR: Hepatosplenic T-cell lymphoma in inflammatory bowel disease: a possible thiopurine-induced chromosomal abnormality. Am J Gastroenterol. 2010, 105: 2299-2301. 10.1038/ajg.2010.213.
Beigel F, Jurgens M, Tillack C, Subklewe M, Mayr D, Goke B, Brand S, Ochsenkuhn T: Hepatosplenic T-cell lymphoma in a patient with Crohn's disease. Nat Rev Gastroenterol Hepatol. 2009, 6: 433-436. 10.1038/nrgastro.2009.87.
Drini M, Prichard PJ, Brown GJ, Macrae FA: Hepatosplenic T-cell lymphoma following infliximab therapy for Crohn's disease. Med J Aust. 2008, 189: 464-465.
He S, Roberts A, Ritchie D, Grigg A: Graft-versus-lymphoma effect in progressive hepatosplenic gamma/delta T-cell lymphoma. Leuk Lymphoma. 2007, 48: 1448-1450. 10.1080/10428190701400071.
Humphreys MR, Cino M, Quirt I, Barth D, Kukreti V: Long-term survival in two patients with hepatosplenic T cell lymphoma treated with interferon-alpha. Leuk Lymphoma. 2008, 49: 1420-1423. 10.1080/10428190802087488.
Mackey AC, Green L, Leptak C, Avigan M: Hepatosplenic T cell lymphoma associated with infliximab use in young patients treated for inflammatory bowel disease: update. J Pediatr Gastroenterol Nutr. 2009, 48: 386-388. 10.1097/MPG.0b013e3181957a11.
Mackey AC, Green L, Liang LC, Dinndorf P, Avigan M: Hepatosplenic T cell lymphoma associated with infliximab use in young patients treated for inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2007, 44: 265-267. 10.1097/MPG.0b013e31802f6424.
Mittal S, Milner BJ, Johnston PW, Culligan DJ: A case of hepatosplenic gamma-delta T-cell lymphoma with a transient response to fludarabine and alemtuzumab. Eur J Haematol. 2006, 76: 531-534. 10.1111/j.1600-0609.2006.00646.x.
Moran G, Dillon J, Green J: Crohn's disease, hepatosplenic T-cell lymphoma and no biological therapy: are we barking up the wrong tree?. Inflamm Bowel Dis. 2009, 15: 1281-1282. 10.1002/ibd.20802.
Ochenrider MG, Patterson DJ, Aboulafia DM: Hepatosplenic T-cell lymphoma in a young man with Crohn's disease: case report and literature review. Clin Lymphoma Myeloma Leuk. 2010, 10: 144-148. 10.3816/CLML.2010.n.021.
Rosh JR, Gross T, Mamula P, Griffiths A, Hyams J: Hepatosplenic T-cell lymphoma in adolescents and young adults with Crohn's disease: a cautionary tale?. Inflamm Bowel Dis. 2007, 13: 1024-1030. 10.1002/ibd.20169.
Shale M, Kanfer E, Panaccione R, Ghosh S: Hepatosplenic T cell lymphoma in inflammatory bowel disease. Gut. 2008, 57: 1639-1641. 10.1136/gut.2008.163279.
Zeidan A, Sham R, Shapiro J, Baratta A, Kouides P: Hepatosplenic T-cell lymphoma in a patient with Crohn's disease who received infliximab therapy. Leuk Lymphoma. 2007, 48: 1410-1413. 10.1080/10428190701345433.
Kotlyar DS, Osterman MT, Diamond RH, Porter D, Blonski WC, Wasik M, Sampat S, Mendizabal M, Lin MV, Lichtenstein GR: A systematic review of factors that contribute to hepatosplenic T-cell lymphoma in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2011, 9: 36-41. 10.1016/j.cgh.2010.09.016. e31
Thai A, Prindiville T: Hepatosplenic T-cell lymphoma and inflammatory bowel disease. J Crohns Colitis. 2010, 4: 511-522. 10.1016/j.crohns.2010.05.006.
Pozadzides JV, Pro B: Hepatosplenic T-cell lymphoma and TNF-alpha inhibitors. Expert Rev Hematol. 2009, 2: 611-614. 10.1586/ehm.09.62.
Grimpen F, Yeung D, Joseph J, Fay K, Buckland M, Talaulikar D, Elijah J, Clarke AC, Pavli P, Moore J: Hepatosplenic T cell lymphoma, immunosuppressive agents and biologicals: What are the risks?. J Gastroenterol Hepatol. 2009, 24: A314-
Kotlyar D, Blonski W, Mendizabal M, Lin MV, Lichtenstein GR: Case report of trisomy 13 in bone marrow in a case of hepatosplenic T-cell lymphoma (HSTCL) and inflammatory bowel disease (IBD). Gastroenterology. 2009, 136: A146-
Kotlyar D, Blonski W, Porter DL, Mendizabal M, Lin MV, Lichtenstein GR: Hepatosplenic T-cell lymphoma (HSTCL) and inflammatory bowel disease (IBD): A rare complication after long-term thiopurine exposure: Case report and systematic review of the literature. Gastroenterology. 2009, 136: A196-A197. 10.1053/j.gastro.2008.09.019.
Lémann M, Gérard de La Valussière F, Carbonnel F, Bouhnik Y, Bonnet J, Allez M, Matuchansky C, Cosnes J, Jian R, Rambaud JC, Gendre JP, Modigliani R: Intravenous cyclosporine for perianal Crohn's disease (CD). Gastroenterology. 1998, 114: A1020-
Falchook GS, Champlin R, Hagemeister FB, Hosing C, Kwak LW, O'Brien S, Rodriguez MA, Verstovsek S, Pro B: Hepatosplenic T-cell lymphoma: clinical characteristics and treatment outcome. ASH Annual, Meeting Abstracts. 2006, 108: 2460-
Fowler S, Beyak M, Depew WT, Justinich C, Ropeleski MJ: W1212 hepatosplenic T-cell lymphoma in Crohn's disease. Where does the risk lie?. Gastroenterology. 2010, 138: 675-
Beaugerie L, Brousse N, Bouvier AM, Colombel JF, Lémann M, Cosnes J, Hébuterne X, Cortot A, Bouhnik Y, Gendre JP, Simon T, Maynadié M, Hermine O, Faivre J, Carrat F, CESAME Study Group: Lymphoproliferative disorders in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study. Lancet. 2009, 374: 1617-1625. 10.1016/S0140-6736(09)61302-7.
Chou R, Aronson N, Atkins D, Ismaila AS, Santaguida P, Smith DH, Whitlock E, Wilt TJ, Moher D: AHRQ series paper 4: assessing harms when comparing medical interventions: AHRQ and the effective health-care program. J Clin Epidemiol. 2010, 63: 502-512. 10.1016/j.jclinepi.2008.06.007.
Agency for Healthcare Research and Quality: Methods guide for medical test reviews. 2010, Rockville, MD: Agency for Healthcare Research and Quality,http://effectivehealthcare.ahrq.gov,
Cochrane handbook for systematic reviews of interventions. Version 5.1.0 (updated March 2011). Edited by: Higgins JPT, Green S. 2011, Oxford: The Cochrane Collaboration,http://www.cochrane-handbook.org,
Jefferson T, Jones M, Doshi P, Del Mar C: Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis. BMJ. 2009, 339: 5106-10.1136/bmj.b5106.
Bybee KA, Kara T, Prasad A, Lerman A, Barsness GW, Wright RS, Rihal CS: Systematic review: transient left ventricular apical ballooning: a syndrome that mimics ST-segment elevation myocardial infarction. Ann Intern Med. 2004, 141: 858-865. 10.7326/0003-4819-141-11-200412070-00010.
Effective Health Care Program: Evidence-based practice center systematic review protocol pressure ulcer treatment strategies: A comparative effectiveness review. 2011, Rockville, MD: Agency for Healthcare Research and Quality,http://effectivehealthcare.ahrq.gov/ehc/products/308/838/Pressure-Ulcer-Treatment_%20Protocol_20111108.pdf,
Reeves BC, Vardulaki KA, Tsang VTC, Bennett-Lloyd BD, O’Riordan PA: A systematic review of case series of paediatric cardiac surgery [abstract]. 2000, Cape Town: 8th Annual Cochrane Colloquium,http://cmr.cochrane.org/?CRGReportID=2998,
Gartlehner G, Hansen RA, Jonas BL, Thieda P, Lohr KN: The comparative efficacy and safety of biologics for the treatment of rheumatoid arthritis: a systematic review and metaanalysis. J Rheumatol. 2006, 33: 2398-2408.
US Food and Drug Administration: The FDA Safety Information and Adverse Event Reporting Program. MedWatch 3500 form. 2013, Silver Spring, MD: US Food and Drug Administration,http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf,
Aronson JK: Anecdotes as evidence. BMJ. 2003, 326: 1346-10.1136/bmj.326.7403.1346.
National Institute of Diabetes and Digestive and Kidney Diseases: Important elements to include in reporting cases of drug-induced liver injury. 2013, Bethesda, MD: National Institute of Diabetes and Digestive and Kidney Diseases,http://livertox.niddk.nih.gov/ImportantElements.aspx,
Sorinola O, Olufowobi O, Coomarasamy A, Khan KS: Instructions to authors for case reporting are limited: a review of a core journal list. BMC Med Educ. 2004, 4: 4-10.1186/1472-6920-4-4.
Institute for Safe Medication Practices: QuarterWatch: Monitoring FDA MedWatch reports: Signals for dabigatran and metoclopramide. 2012, Horsham, PA: Institute for Safe Medication Practices,http://www.ismp.org/quarterwatch/pdfs/2011Q1.pdf,
Moore TJ, Singh S, Furberg CD: The FDA and new safety warnings. Arch Intern Med. 2012, 172: 78-80. 10.1001/archinternmed.2011.618.
Larvol L, Soule JC, Le Tourneau A: Reversible lymphoma in the setting of azathioprine therapy for Crohn's disease. N Engl J Med. 1994, 331: 883-884.
US Food and Drug Administration: FDA drug safety communication: Update on tumor necrosis factor (TNF) blockers and risk for pediatric malignancy. 2013, Silver Spring, MD: US Food and Drug Administration,http://www.fda.gov/Drugs/DrugSafety/ucm278267.htm,
Lichtenstein GR, Feagan BG, Cohen RD, Salzberg BA, Diamond RH, Chen DM, Pritchard ML, Sandborn WJ: Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. Clin Gastro and Hepatol. 2006, 4: 621-630. 10.1016/j.cgh.2006.03.002.
International Congress on Peer Review and Biomedical Publication: The Seventh International Congress on Peer Review and Biomedical Publication, September 8–10, 2013. 2013, Chicago, IL: JAMA and London: BMJ,http://www.peerreviewcongress.org/preliminary-program.html,