Oral immunotherapy for milk allergy

Joanne P Yeung, Lorie A Kloda, Jason McDevitt, Moshe Ben-Shoshan, Reza Alizadehfar, Joanne P Yeung, Lorie A Kloda, Jason McDevitt, Moshe Ben-Shoshan, Reza Alizadehfar

Abstract

Background: The mainstay of treatment of IgE-mediated cow milk allergy (IMCMA) is an avoidance diet, which is especially difficult with a ubiquitous food like milk. Milk oral immunotherapy (MOIT) may be an alternative treatment, through desensitization or induction of tolerance.

Objectives: We aim to assess the clinical efficacy and safety of MOIT in children and adults with IMCMA as compared to a placebo treatment or avoidance strategy.

Search methods: We searched 13 databases for journal articles, conference proceedings, theses and unpublished trials, without language or date restrictions, using a combination of subject headings and text words. The search is up-to-date as of October 1, 2012.

Selection criteria: Only randomised controlled trials (RCT) were considered for inclusion. Blinded and open trial designs were included. Children and adults with IMCMA were included. MOIT administered by any protocol were included.

Data collection and analysis: A total of 2111 unique records were identified and screened for potential inclusion. Studies were selected, data extracted and methodological quality assessed independently by two reviewers. We attempted to contact the study investigators to inquire about data not published that was required for the analysis. Statistical heterogeneity was assessed using the I² test. We estimated a pooled risk ratio (RR) for each outcome using a Mantel-Haenzel fixed-effect model if statistical heterogeneity was low as evaluated by an I² value less than 50%.

Main results: Of 157 records reviewed, 16 were included, representing five trials. In general, the studies were small and had inconsistent methodological rigor. Overall, the quality of evidence was rated as low. Each study used a different MOIT protocol. A total of 196 patients were studied (106 MOIT, 90 control) and all were children. Three studies were blinded and two used an avoidance diet control. Sixty-six patients (62%) in the MOIT group were able to tolerate a full serving of milk (about 200 mL) compared to seven (8%) of the control group (RR 6.61, 95% CI 3.51 to 12.44). In addition, 27 (25%) in the MOIT group could ingest a partial serving of milk (10 to 184 mL) while none could in the control group (RR 9.34, 95% CI 2.72 to 32.09). None of the studies assessed the patients following a period off immunotherapy. Adverse reactions were common (97 of 106 MOIT patients had at least one symptom), although most were local and mild. Because of variability in reporting methods, adverse effects could not be combined quantitatively. For every 11 patients receiving MOIT, one required intramuscular epinephrine. One patient required it on two occasions.

Authors' conclusions: Studies to date have involved small numbers of patients and the quality of evidence is generally low. The current evidence shows that MOIT can lead to desensitization in the majority of individuals with IMCMA although the development of long-term tolerance has not been established. A major drawback of MOIT is the frequency of adverse effects, although most are mild and self-limited. The use of parenteral epinephrine is not infrequent. Because there are no standardized protocols, guidelines would be required prior to incorporating desensitization into clinical practice.

Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

1
1
Results from searching for studies for inclusion in the review
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
3
3
Forest plot of comparison: 1 MOIT versus control, outcome: 1.1 Full desensitization.
1.1. Analysis
1.1. Analysis
Comparison 1 MOIT versus control, Outcome 1 Full desensitization.
1.2. Analysis
1.2. Analysis
Comparison 1 MOIT versus control, Outcome 2 Full desensitization ‐ Subgroup analysis of patients 4 years and older.
1.3. Analysis
1.3. Analysis
Comparison 1 MOIT versus control, Outcome 3 Full desensitization ‐ Subgroup analysis of patients without a history of anaphylaxis.
1.4. Analysis
1.4. Analysis
Comparison 1 MOIT versus control, Outcome 4 Partial desensitization.

References

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Crisafulli 2012 {published data only}
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de Boissieu 2006 {published data only}
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Dona Diaz 2007 {published data only}
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Dupont 2010 {published data only}
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Farmakas 2009 {published data only}
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Firszt 2011 {published data only}
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Fisher 2011 {published data only}
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Frutos 2012 {published data only}
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Hague 2012 {published data only}
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Kaneko 2010 {published data only}
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Katz 2011 {published data only}
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Keet 2010 {published data only}
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LeBovidge 2012 {published data only}
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Nadeau 2012 {published data only}
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Nieto 2010 {published data only}
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Niggemann 2006a {published data only}
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Noh 2009 {published data only}
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Nowak‐Wegrzyn 2008 {published data only}
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Nowak‐Wegrzyn 2010 {published data only}
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Nucera 2000 {published data only}
    1. Nucera E, Schiavino D, D'Ambrosio C, Stabile A, Rumi C, Gasbarrini G, et al. CASE REPORT: Immunological aspects of oral desensitization in food allergy. Digestive Diseases and Sciences 2000;45:637‐41.
Nucera 2008 {published data only}
    1. Nucera E, Schiavino D, Buonomo A, Pollastrini E, Altomonte G, Pecora V, et al. Sublingual‐oral rush desensitization to mixed cow and sheep milk: a case report. Journal of Investigational Allergology & Clinical Immunology 2008;18:219‐22.
Ojeda Fernandez 2007 {published data only}
    1. Ojeda Fernandez P, Ojeda Fernandez I, Garcia‐Cubillana A, Pineda F, Ojeda Casas J. Oral desensitisation with milk in pediatric patients allergic to cow's milk proteins. Abstract from 26th Congress of the European Academy of Allergology and Clinical Immunology, Goteborg, Sweden. Allergy 2007; Vol. 62:353.
Oppenheimer 2010 {published data only}
    1. Oppenheimer J, Bock SA. Cow's milk allergy: is there a cure?. Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma & Immunology 2010;105:326‐7.
Paiva 2009 {published data only}
    1. Paiva M, Gaspar A, Antunes J, Silva I, Pinto L. Successful oral rush desensitisation in two children with severe cow's milk allergy. Abstract from 28th Congress of the European Academy of Allergy and Clinical Immunology, Warsaw, Poland. Allergy 2009; Vol. 64.
Pajno 2011 {published data only}
    1. Pajno GB. Oral desensitization for milk allergy in children: State of the art. Current Opinion in Allergy & Clinical Immunology 2011;11(6):560‐4.
Pajno 2011a {published data only}
    1. Pajno Giovanni B, Finegold I. SIT beyond respiratory diseases. Annals of Allergy, Asthma, & Immunology 2011;107:395‐400.
Passalacqua 2012 {published data only}
    1. Passalacqua G, Landi M, Pajno GB. Oral immunotherapy for cow's milk allergy. Current Opinion in Allergy and Clinical Immunology 2012;12:271‐7.
Patriarca 2003 {published data only}
    1. Patriarca G, Buonomo A, Roncallo C, Ninno M, Pollastrini E, Milani A, et al. Oral desensitisation in cow milk allergy: Immunological findings. International Journal of Immunopathology & Pharmacology 2002;15:53‐8.
    1. Patriarca G, Nucera E, Roncallo C, Pollastrini E, Bartolozzi F, Pasquale T, et al. Oral desensitizing treatment in food allergy: clinical and immunological results. Alimentary pharmacology & therapeutics 2003;17:459‐65.
    1. Patriarca G, Schiavino D, Nucera E, Schinco G, Milani A, Gasbarrini GB. Food allergy in children: results of a standardized protocol for oral desensitization. Hepato‐Gastroenterology 1998;45:52‐8.
Patriarca 2007 {published data only}
    1. Patriarca G, Nucera E, Pollastrini E, Roncallo C, Pasquale T, Lombardo C, et al. Oral specific desensitization in food‐allergic children. Digestive Diseases & Sciences 2007;52:1662‐72.
Pecora 2009 {published data only}
    1. Pecora V, Aruanno A, Lombardo C, Nucera E, Schiavino D, Bardina L, et al. Peptide microarray immunoassay: evaluation of specific sequential IgE‐ and IgG4‐binding epitopes, recognised in patients allergic to cow's milk during specific oral desensitisation. Allergy 2009;64.
    1. Pecora V, Nucera E, et al. Evaluation of specific sequential IgE‐ and IgG4‐binding epitopes, recognized in cow's milk allergic patients during specific oral desensitization, using peptide microarray immunoassay. Journal of Allergy & Clinical Immunology 2009;123(2 Suppl S):S178.
Poisson 1988 {published data only}
    1. Poisson A, Thomas G, Jean‐Landais N, Giaufre E. Rapid Oral Tolerance to Cow‐Milk in a Case of Severe Food Allergy in a Child. Allergie et Immunologie 1988;20:67‐8.
Rancitelli 2011 {published data only}
    1. Rancitelli P, Hofmann A, Wesley BA. Vaccine approaches for food allergy. Vaccines against Allergies, Current Topics in Microbiology and Immunology. Springer Verlag, 2011:55‐69.
Rapp 1978 {published data only}
    1. Rapp DJ. Double‐blind confirmation and treatment of milk sensitivity. Medical Journal of Australia 1978;1:571‐2.
Reche 2009 {published data only}
    1. Reche M, Valbuena T, Fiandorz A, Padial MA, Martin‐Esteban M, Pascual C. Specific Oral Tolerance Induction In Children With Systemic Cow Milk Allergy. Journal of Allergy & Clinical Immunology 2009;123:S210.
Reche 2011 {published data only}
    1. Reche M, Valbuena T, Fiandor A, Padial A, Caete A, Pascual C. Early induction of oral tolerance protocol (OTI) in children with cow's milk allergy [Abstract]. Journal of Allergy and Clinical Immunology 2011:Ab24.
Rodriguez‐Alvarez 2007 {published data only}
    1. Rodriguez‐Alvarez M, Fernandez Rivas M, Rincon de Arellano I, Vazquez Cortes S, Santos Magadan S, Robledo Echarren T, et al. Oral desensitisation in persistent cow's milk allergy. Abstract from 26th Congress of the European Academy of Allergology and Clinical Immunology, Goteborg, Sweden. Allergy 2007; Vol. 62:55.
    1. Rodriguez‐Alvarez M, Fernandez Rivas M, Vazquez‐Cortes S, Rodriguez del Rio P, Zayas L, Robledo Echarren T, et al. Follow up of desensitised patients and immunological changes after specific oral tolerance induction to milk. Abstract from 28th Congress of the European Academy of Allergy and Clinical Immunology, Warsaw, Poland. Allergy 2009; Vol. 64:481‐2.
    1. Rodriguez‐Alvarez M, Fernandez‐Rivas M, Robledo Echarren T, Martinez‐Cocera C. Persistence of Tolerance After Specific Oral Tolerance Induction. Journal of Allergy & Clinical Immunology 2010;125:AB22.
    1. Rodriguez‐Alvarez M, Rivas M Fernandez, Echarren T Robledo, Cortes S Vazquez, Martinez‐Cocera C. Prognostic markers for specific oral tolerance induction (SOTI) to milk. Journal of Allergy & Clinical Immunology 2009;123:S25.
Rolinck‐Werninghaus 2005a {published data only}
    1. Rolinck‐Werninghaus C, Staden U, Mehl A, Hamelmann E, Beyer K, Niggemann B. Specific oral tolerance induction with food in children: transient or persistent effect on food allergy?. Allergy 2005;60:1320‐2.
Rosenwasser 2011 {published data only}
    1. Rosenwasser LJ. Critical documents on cow's milk allergy and anaphylaxis: Two recent WAO position papers. World Allergy Organization Journal 2011;4:76.
Saltzman 2012 {published data only}
    1. Saltzman RW, Kelleher M, Brown‐Whitehorn T, Fiedler J, Corry J, Gober L, et al. Milk oral immunotherapy: a single‐center pilot study of safety and efficacy. Journal of Allergy & Clinical Immunology 2012;129(2, Suppl. S):AB25.
Sampson 1997 {published data only}
    1. Sampson HA. Food allergy. JAMA: The Journal of the American Medical Association 1997;278:1888.
Sampson 2003 {published data only}
    1. Sampson HA. Food allergy. Journal of Allergy & Clinical Immunology 2003;111:S540‐7.
Sampson 2010 {published data only}
    1. Sampson H. OIT and Xolair® (Omalizumab) in Cow's Milk Allergy. .
Sanchez‐Garcia 2011 {published data only}
    1. Sanchez‐Garcia S, Escudero C, Rio PR, Garcia‐Fernandez C, Ortega‐Casanueva C, Lopez‐Torrijos A, et al. Adverse Reactions (AR) during milk Oral Immunotherapy (mOIT) and its Relationship with specific IgE (sIgE) in 105 Milk‐allergic Patients. Journal of Allergy and Clinical Immunology 2011;127:AB29.
Saretta 2012 {published data only}
    1. Saretta F, Saltzman R W, Abraham V, Dudek E, Spergel J, Cianferoni A. Milk oral desensitization: role of invariant natural killer T cells (iNKTs). Journal of Allergy & Clinical Immunology 2012;129(2, Suppl. S):AB26.
Schiavino 2001 {published data only}
    1. Schiavino D, Buonomo A, Ninno M, Roncallo C, Pollastrini E, Camerini A, et al. Oral specific desensitization and immunologic modifications in 4 children with milk allergy. Abstract from XXth Congress of the European Academy of Allergology and Clinical Immunology, Berlin, Germany. Allergy 2001; Vol. 56:95‐6.
Schmidt 2007 {published data only}
    1. Schmidt I, Hipler UC, Kaatz M, Elsner P, Bauer A. Oral rush desensitization in a boy with severe IgE mediated cow's milk allergy. [German]. Allergologie 2007;30:372‐7.
Scurlock 2009 {published data only}
    1. Scurlock AM, Burks AW, Jones, SM. Oral immunotherapy for food allergy. Current Allergy and Asthma Reports 2009;9(3):186‐193.
Seopaul 2012 {published data only}
    1. Seopaul S, Keet CA, Frischmeyer‐Guerrerio PA, Thyagarajan A, Schroeder JT, Hamilton R, et al. Prolonged exposure to sublingual immunotherapy improves safety of oral immunotherapy. Journal of Allergy and Clinical Immunology 2012;1:AB126.
Sicherer 2003 {published data only}
    1. Sicherer SH. Advances in anaphylaxis and hypersensitivity reactions to foods, drugs, and insect venom. Journal of Allergy and Clinical Immunology 2003;111:S829‐34.
Sicherer 2009 {published data only}
    1. Sicherer SH, Sampson HA. Food allergy: recent advances in pathophysiology and treatment. Annual review of medicine 2009;60:261‐77.
Simons 2010 {published data only}
    1. Simons E, Moretti M. Optimizing oral immunotherapy to cow milk protein: a decision analysis. Allergy, Asthma & Clinical Immunology 2010;6:P7.
Skripak 2009 {published data only}
    1. Skripak JM, Wood RA. Mammalian milk allergy: avoidance strategies and oral desensitization. Current Opinion in Allergy and Clinical Immunology 2009;9:259.
Staden 2007 {published data only}
    1. Staden U, Rolinck‐Werninghaus C, Brewe F, Wahn U, Niggemann B, Beyer K. Specific oral tolerance induction in food allergy in children: efficacy and clinical patterns of reaction. Allergy 2007;62:1261‐9.
Staden 2008 {published data only}
    1. Staden U, Bluemchen K, Dannenberg N, Staab D, Wahn U, Niggemann B, et al. Oral tolerance induction with a rush protocol in children with persistent cow's milk allergy. 26th Congress of the European Academy of Allergology and Clinical Immunology, Goteborg, Sweden. Allergy 2007; Vol. 62:353.
    1. Staden U, Blumchen K, Blankenstein N, Dannenberg N, Ulbricht H, Dobberstein K, et al. Rush oral immunotherapy in children with persistent cow's milk allergy. Journal of Allergy & Clinical Immunology 2008;122:418‐9.
Stein 2011 {published data only}
    1. Stein ML, Goldberg MR, Levy MB, Herman G, Broide E, Elizur A, et al. Non‐IgE Mediated Reactions to Milk Oral Immunotherapy (MOI). Journal of Allergy & Clinical Immunology 2011;127:AB30.
Steinman 2008 {published data only}
    1. Steinman HH. Oral rush desensitisation to cow's milk in a severely cow's milk‐allergic adult. Allergy 2008;63(Suppl):88.
Strobel 2006 {published data only}
    1. Strobel S, Mowat AMI. Oral tolerance and allergic responses to food proteins. Current Opinion in Allergy and Clinical Immunology 2006;6:207.
Tunis 2010 {published data only}
    1. Tunis M, Marshall JS. Does IgE‐mediated mast cell activation reduce oral tolerance to food antigens?. Allergy, Asthma & Clinical Immunology 2010;6:P18.
Vickery 2010 {published data only}
    1. Vickery BP, Burks W. Oral immunotherapy for food allergy. Current Opinion in Pediatrics 2010;22:765‐70.
Wasserman 2010 {published data only}
    1. Wasserman RL, Mansfield LE, Gallucci AR, Hutteman HR, Ruvalcaba AM, Long NA, et al. Office based oral desensitization of patients with anaphylactic sensitivity to foods is safe and effective. Journal of Allergy & Clinical Immunology 2010;125:AB59.
Wuethrich 1996 {published data only}
    1. Wuethrich B. Oral desensitization with cow's milk in cow's milk allergy: Pro. In: Wuethrich B, Ortolani C editor(s). Highlights in Food Allergy: 6th International Symposium on Immunological and Clinical Problems of Food Allergy, Lugano, September, 1995. Basel, Switzerland: S. Karger AG, 1996:236‐40.
Yanagida 2010 {published data only}
    1. Yanagida N, Utsunomiya T, Sato S, Iguchi M, Komata T, Imai T, et al. Treatment of Hen's Egg‐ and Cow's Milk‐induced Anaphylaxis by Rash Oral Immunotherapy. 2010 Annual Meeting of the American Academy of Allergy Asthma and Immunology (AAAAI 2010) 2010.
Zapatero 2008 {published data only}
    1. Zapatero L, Alonso E, Fuentes V, Martínez MI. Oral desensitization in children with cow's milk allergy. Journal of Investigational Allergology and Clinical Immunology 2008;18:389‐96.
Zein 2011 {published data only}
    1. Zein F, Kim H. Skin prick testing with extensively heated milk or egg products helps predict the outcome of an oral food challenge: A retrospective analysis. Allergy, Asthma & Clinical Immunology 2011;7(Suppl 2):A9.
References to ongoing studies Katsunuma 2012 {published data only}
    1. Katsunuma T. Effect of oral immunotherapy in preschool children with milk allergy; Trial for the detection of prospective markers for the effectiveness. .
Additional references Allen 2009
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Bishop 1990
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Bock 2007
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