Association of Serum Calprotectin (S100A8/A9) Level With Disease Relapse in Proteinase 3-Antineutrophil Cytoplasmic Antibody-Associated Vasculitis
Pepper RJ, Draibe JB, Caplin B, Fervenza FC, Hoffman GS, Kallenberg CG, Langford CA, Monach PA, Seo P, Spiera R, William St Clair E, Tchao NK, Stone JH, Specks U, Merkel PA, Salama AD, RAVE-Immune Tolerance Network Research Group
Associated Clinical Trial(s):
Pepper RJ, Draibe JB, Caplin B, Fervenza FC, Hoffman GS, Kallenberg CG, Langford CA, Monach PA, Seo P, Spiera R, William St Clair E, Tchao NK, Stone JH, Specks U, Merkel PA, Salama AD, RAVE-Immune Tolerance Network Research Group (2017). Association of Serum Calprotectin (S100A8/A9) Level With Disease Relapse in Proteinase 3-Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Rheumatol, 69(1), 185-193. https://doi.org/10.1002/art.39814 PMID: 27428710. PMCID: PMC5839649.
The Pharmacogenomic Association of Fcγ Receptors and Cytochrome P450 Enzymes With Response to Rituximab or Cyclophosphamide Treatment in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis
Cartin-Ceba R, Indrakanti D, Specks U, Stone JH, Hoffman GS, Kallenberg CG, Langford CA, Merkel PA, Spiera RF, Monach PA, St Clair EW, Seo P, Tchao NK, Ytterberg SR, Brunetta PG, Song H, Birmingham D, Rovin BH, RAVE-Immune Tolerance Network Research Group
Associated Clinical Trial(s):
Cartin-Ceba R, Indrakanti D, Specks U, Stone JH, Hoffman GS, Kallenberg CG, Langford CA, Merkel PA, Spiera RF, Monach PA, St Clair EW, Seo P, Tchao NK, Ytterberg SR, Brunetta PG, Song H, Birmingham D, Rovin BH, RAVE-Immune Tolerance Network Research Group (2017). The Pharmacogenomic Association of Fcγ Receptors and Cytochrome P450 Enzymes With Response to Rituximab or Cyclophosphamide Treatment in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Rheumatol, 69(1), 169-175. https://doi.org/10.1002/art.39822 PMID: 27482943.
Effect of Disease Activity, Glucocorticoid Exposure, and Rituximab on Body Composition During Induction Treatment of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis
Wallace ZS, Miloslavsky EM, Cascino M, Unizony SH, Lu N, Hoffman GS, Kallenberg CGM, Langford CA, Merkel PA, Monach PA, Seo P, Spiera R, St Clair EW, Specks U, Brunetta P, Choi HK, Stone JH
Associated Clinical Trial(s):
Wallace ZS, Miloslavsky EM, Cascino M, Unizony SH, Lu N, Hoffman GS, Kallenberg CGM, Langford CA, Merkel PA, Monach PA, Seo P, Spiera R, St Clair EW, Specks U, Brunetta P, Choi HK, Stone JH (2017). Effect of Disease Activity, Glucocorticoid Exposure, and Rituximab on Body Composition During Induction Treatment of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Care Res (Hoboken), 69(7), 1004-1010. https://doi.org/10.1002/acr.23099 PMID: 27696762. PMCID: PMC5611860.
ACCLAIM: A randomized trial of abatacept (CTLA4-Ig) for relapsing-remitting multiple sclerosis
Khoury SJ, Rochon J, Ding L, Byron M, Ryker K, Tosta P, Gao W, Freedman MS, Arnold DL, Sayre PH, Smilek DE, ACCLAIM Study Group
Associated Clinical Trial(s):
Khoury SJ, Rochon J, Ding L, Byron M, Ryker K, Tosta P, Gao W, Freedman MS, Arnold DL, Sayre PH, Smilek DE, ACCLAIM Study Group (2017). ACCLAIM: A randomized trial of abatacept (CTLA4-Ig) for relapsing-remitting multiple sclerosis. Mult Scler, 23(5), 686-695. https://doi.org/10.1177/1352458516662727 PMID: 27481207. PMCID: PMC5288398.
Letter of response to Greenhawt et al. 'LEAPing Through the Looking Glass: Secondary Analysis of the Effect of Skin Test Size and Age of Introduction on Peanut Tolerance after Early Peanut Introduction'
Lawson K, Bahnson HT, Brittain E, Sever M, Du Toit G, Lack G, Keet C, Greenhawt M, Fleischer D, Chan ES, Venter C, Stukus D, Gupta R, Spergel J
Associated Clinical Trial(s):
Lawson K, Bahnson HT, Brittain E, Sever M, Du Toit G, Lack G, Keet C, Greenhawt M, Fleischer D, Chan ES, Venter C, Stukus D, Gupta R, Spergel J (2017). Letter of response to Greenhawt et al. 'LEAPing Through the Looking Glass: Secondary Analysis of the Effect of Skin Test Size and Age of Introduction on Peanut Tolerance after Early Peanut Introduction'. Allergy, 72(8), 1267-1271. https://doi.org/10.1111/all.13127 PMID: 28691223. PMCID: PMC5796413.
Statistical Considerations of Food Allergy Prevention Studies
Bahnson HT, du Toit G, Lack G
Associated Clinical Trial(s):
Bahnson HT, du Toit G, Lack G (2017). Statistical Considerations of Food Allergy Prevention Studies. J Allergy Clin Immunol Pract, 5(2), 274-282. https://doi.org/10.1016/j.jaip.2016.12.007 PMID: 28283152. PMCID: PMC5683073.
Food Allergy: Unmet Needs and New Perspectives
Wang J, Lack G
Associated Clinical Trial(s):
Wang J, Lack G (2017). Food Allergy: Unmet Needs and New Perspectives. J Allergy Clin Immunol Pract, 5(2), 295. https://doi.org/10.1016/j.jaip.2017.01.002 PMID: 28283155.
LEAPing through the looking glass: secondary analysis of the effect of skin test size and age of introduction on peanut tolerance after early peanut introduction
Greenhawt M, Fleischer DM, Chan ES, Venter C, Stukus D, Gupta R, Spergel JM
Associated Clinical Trial(s):
Greenhawt M, Fleischer DM, Chan ES, Venter C, Stukus D, Gupta R, Spergel JM (2017). LEAPing through the looking glass: secondary analysis of the effect of skin test size and age of introduction on peanut tolerance after early peanut introduction. Allergy, 72(8), 1254-1260. https://doi.org/10.1111/all.13100 PMID: 27896827. PMCID: PMC5447487.
Effect of 2 Years of Treatment With Sublingual Grass Pollen Immunotherapy on Nasal Response to Allergen Challenge at 3 Years Among Patients With Moderate to Severe Seasonal Allergic Rhinitis: The GRASS Randomized Clinical Trial
Scadding GW, Calderon MA, Shamji MH, Eifan AO, Penagos M, Dumitru F, Sever ML, Bahnson HT, Lawson K, Harris KM, Plough AG, Panza JL, Qin T, Lim N, Tchao NK, Togias A, Durham SR, Immune Tolerance Network GRASS Study Team
Associated Clinical Trial(s):
Scadding GW, Calderon MA, Shamji MH, Eifan AO, Penagos M, Dumitru F, Sever ML, Bahnson HT, Lawson K, Harris KM, Plough AG, Panza JL, Qin T, Lim N, Tchao NK, Togias A, Durham SR, Immune Tolerance Network GRASS Study Team (2017). Effect of 2 Years of Treatment With Sublingual Grass Pollen Immunotherapy on Nasal Response to Allergen Challenge at 3 Years Among Patients With Moderate to Severe Seasonal Allergic Rhinitis: The GRASS Randomized Clinical Trial. JAMA, 317(6), 615-625. https://doi.org/10.1001/jama.2016.21040 PMID: 28196255. PMCID: PMC5479315.
Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants
Perkin MR, Logan K, Tseng A, Raji B, Ayis S, Peacock J, Brough H, Marrs T, Radulovic S, Craven J, Flohr C, Lack G, EAT Study Team
Associated Clinical Trial(s):
Perkin MR, Logan K, Tseng A, Raji B, Ayis S, Peacock J, Brough H, Marrs T, Radulovic S, Craven J, Flohr C, Lack G, EAT Study Team (2016). Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants. N Engl J Med, 374(18), 1733-43. https://doi.org/10.1056/NEJMoa1514210 PMID: 26943128.
Features of patients screened for calibrate (rituximab plus cyclophosphamide followed by belimumab for the treatment of lupus nephritis); hypogammaglobulinemia is frequent in patients with marked elevation of urinary protein
Associated Clinical Trial(s):
Aranow, C, Diamond, B, Wofsy, D, Byron, M, Smilek, D, Ding, L, Tosta, P, Ryker, K, Gao, W, Dall’Era, M, Features of patients screened for calibrate (rituximab plus cyclophosphamide followed by belimumab for the treatment of lupus nephritis); hypogammaglobulinemia is frequent in patients with marked elevation of urinary protein. https://doi.org/10.1136/lupus-2016-000179.74
International Consensus on Allergen Immunotherapy II: Mechanisms, standardization, and pharmacoeconomics
Jutel M, Agache I, Bonini S, Burks AW, Calderon M, Canonica W, Cox L, Demoly P, Frew AJ, O'Hehir R, Kleine-Tebbe J, Muraro A, Lack G, Larenas D, Levin M, Martin BL, Nelson H, Pawankar R, Pfaar O, van Ree R, Sampson H, Sublett JL, Sugita K, Du Toit G, Werfel T, Gerth van Wijk R, Zhang L, Akdis M, Akdis CA
Associated Clinical Trial(s):
Jutel M, Agache I, Bonini S, Burks AW, Calderon M, Canonica W, Cox L, Demoly P, Frew AJ, O'Hehir R, Kleine-Tebbe J, Muraro A, Lack G, Larenas D, Levin M, Martin BL, Nelson H, Pawankar R, Pfaar O, van Ree R, Sampson H, Sublett JL, Sugita K, Du Toit G, Werfel T, Gerth van Wijk R, Zhang L, Akdis M, Akdis CA (2016). International Consensus on Allergen Immunotherapy II: Mechanisms, standardization, and pharmacoeconomics. J Allergy Clin Immunol, 137(2), 358-68. https://doi.org/10.1016/j.jaci.2015.12.1300 PMID: 26853128.
Clinical trial data access: Opening doors with TrialShare
Asare AL, Carey VJ, Rotrosen D, Nepom GT
Associated Clinical Trial(s):
Asare AL, Carey VJ, Rotrosen D, Nepom GT (2016). Clinical trial data access: Opening doors with TrialShare. J Allergy Clin Immunol, 138(3), 724-726. https://doi.org/10.1016/j.jaci.2016.05.034 PMID: 27474121.
Obstacles and opportunities for targeting the effector T cell response in type 1 diabetes
Buckner JH, Nepom GT
Associated Clinical Trial(s):
Buckner JH, Nepom GT (2016). Obstacles and opportunities for targeting the effector T cell response in type 1 diabetes. J Autoimmun, 71, 44-50. https://doi.org/10.1016/j.jaut.2016.02.009 PMID: 26948997. PMCID: PMC4903876.
Strategies for clinical trials in type 1 diabetes
Ehlers MR
Associated Clinical Trial(s):
Ehlers MR (2016). Strategies for clinical trials in type 1 diabetes. J Autoimmun, 71, 88-96. https://doi.org/10.1016/j.jaut.2016.03.008 PMID: 27068279. PMCID: PMC4903883.
Immune interventions to preserve β cell function in type 1 diabetes
Ehlers MR
Associated Clinical Trial(s):
Ehlers MR (2016). Immune interventions to preserve β cell function in type 1 diabetes. J Investig Med, 64(1), 7-13. https://doi.org/10.1097/JIM.0000000000000227 PMID: 26225763. PMCID: PMC4732932.
Partial exhaustion of CD8 T cells and clinical response to teplizumab in new-onset type 1 diabetes
Long SA, Thorpe J, DeBerg HA, Gersuk V, Eddy J, Harris KM, Ehlers M, Herold KC, Nepom GT, Linsley PS
Associated Clinical Trial(s):
Long SA, Thorpe J, DeBerg HA, Gersuk V, Eddy J, Harris KM, Ehlers M, Herold KC, Nepom GT, Linsley PS (2016). Partial exhaustion of CD8 T cells and clinical response to teplizumab in new-onset type 1 diabetes. Sci Immunol, 1(5). https://doi.org/10.1126/sciimmunol.aai7793 PMID: 28664195. PMCID: PMC5486405.
Correlation Among Hypoglycemia, Glycemic Variability, and C-Peptide Preservation After Alefacept Therapy in Patients with Type 1 Diabetes Mellitus: Analysis of Data from the Immune Tolerance Network T1DAL Trial
Pinckney A, Rigby MR, Keyes-Elstein L, Soppe CL, Nepom GT, Ehlers MR
Associated Clinical Trial(s):
Pinckney A, Rigby MR, Keyes-Elstein L, Soppe CL, Nepom GT, Ehlers MR (2016). Correlation Among Hypoglycemia, Glycemic Variability, and C-Peptide Preservation After Alefacept Therapy in Patients with Type 1 Diabetes Mellitus: Analysis of Data from the Immune Tolerance Network T1DAL Trial. Clin Ther, 38(6), 1327-1339. https://doi.org/10.1016/j.clinthera.2016.04.032 PMID: 27209482. PMCID: PMC4916002.
Antithymocyte globulin therapy for patients with recent-onset type 1 diabetes: 2 year results of a randomised trial
Gitelman SE, Gottlieb PA, Felner EI, Willi SM, Fisher LK, Moran A, Gottschalk M, Moore WV, Pinckney A, Keyes-Elstein L, Harris KM, Kanaparthi S, Phippard D, Ding L, Bluestone JA, Ehlers MR, ITN START Study Team
Associated Clinical Trial(s):
Gitelman SE, Gottlieb PA, Felner EI, Willi SM, Fisher LK, Moran A, Gottschalk M, Moore WV, Pinckney A, Keyes-Elstein L, Harris KM, Kanaparthi S, Phippard D, Ding L, Bluestone JA, Ehlers MR, ITN START Study Team (2016). Antithymocyte globulin therapy for patients with recent-onset type 1 diabetes: 2 year results of a randomised trial. Diabetologia, 59(6), 1153-61. https://doi.org/10.1007/s00125-016-3917-4 PMID: 27053235. PMCID: PMC4869699.
Two- and Four-Hour Tests Differ in Capture of C-Peptide Responses to a Mixed Meal in Type 1 Diabetes
Boyle KD, Keyes-Elstein L, Ehlers MR, McNamara J, Rigby MR, Gitelman SE, Weiner LJ, Much KL, Herold KC
Associated Clinical Trial(s):
Boyle KD, Keyes-Elstein L, Ehlers MR, McNamara J, Rigby MR, Gitelman SE, Weiner LJ, Much KL, Herold KC (2016). Two- and Four-Hour Tests Differ in Capture of C-Peptide Responses to a Mixed Meal in Type 1 Diabetes. Diabetes Care, 39(6), e76-8. https://doi.org/10.2337/dc15-2077 PMID: 27208317. PMCID: PMC4878222.
A Preclinical Consortium Approach for Assessing the Efficacy of Combined Anti-CD3 Plus IL-1 Blockade in Reversing New-Onset Autoimmune Diabetes in NOD Mice
Gill RG, Pagni PP, Kupfer T, Wasserfall CH, Deng S, Posgai A, Manenkova Y, Bel Hani A, Straub L, Bernstein P, Atkinson MA, Herold KC, von Herrath M, Staeva T, Ehlers MR, Nepom GT
Associated Clinical Trial(s):
Gill RG, Pagni PP, Kupfer T, Wasserfall CH, Deng S, Posgai A, Manenkova Y, Bel Hani A, Straub L, Bernstein P, Atkinson MA, Herold KC, von Herrath M, Staeva T, Ehlers MR, Nepom GT (2016). A Preclinical Consortium Approach for Assessing the Efficacy of Combined Anti-CD3 Plus IL-1 Blockade in Reversing New-Onset Autoimmune Diabetes in NOD Mice. Diabetes, 65(5), 1310-6. https://doi.org/10.2337/db15-0492 PMID: 26718498. PMCID: PMC5860426.
Changes in T-cell subsets identify responders to FcR-nonbinding anti-CD3 mAb (teplizumab) in patients with type 1 diabetes
Tooley JE, Vudattu N, Choi J, Cotsapas C, Devine L, Raddassi K, Ehlers MR, McNamara JG, Harris KM, Kanaparthi S, Phippard D, Herold KC
Associated Clinical Trial(s):
Tooley JE, Vudattu N, Choi J, Cotsapas C, Devine L, Raddassi K, Ehlers MR, McNamara JG, Harris KM, Kanaparthi S, Phippard D, Herold KC (2016). Changes in T-cell subsets identify responders to FcR-nonbinding anti-CD3 mAb (teplizumab) in patients with type 1 diabetes. Eur J Immunol, 46(1), 230-41. https://doi.org/10.1002/eji.201545708 PMID: 26518356. PMCID: PMC4882099.
Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States
Brennan DC, Kopetskie HA, Sayre PH, Alejandro R, Cagliero E, Shapiro AM, Goldstein JS, DesMarais MR, Booher S, Bianchine PJ
Associated Clinical Trial(s):
Brennan DC, Kopetskie HA, Sayre PH, Alejandro R, Cagliero E, Shapiro AM, Goldstein JS, DesMarais MR, Booher S, Bianchine PJ (2016). Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States. Am J Transplant, 16(2), 509-17. https://doi.org/10.1111/ajt.13458 PMID: 26433206.
Myeloperoxidase-Antineutrophil Cytoplasmic Antibody (ANCA)-Positive and ANCA-Negative Patients With Granulomatosis With Polyangiitis (Wegener's): Distinct Patient Subsets
Miloslavsky EM, Lu N, Unizony S, Choi HK, Merkel PA, Seo P, Spiera R, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Tchao NK, Fervenza F, Monach PA, Specks U, Stone JH
Associated Clinical Trial(s):
Miloslavsky EM, Lu N, Unizony S, Choi HK, Merkel PA, Seo P, Spiera R, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Tchao NK, Fervenza F, Monach PA, Specks U, Stone JH (2016). Myeloperoxidase-Antineutrophil Cytoplasmic Antibody (ANCA)-Positive and ANCA-Negative Patients With Granulomatosis With Polyangiitis (Wegener's): Distinct Patient Subsets. Arthritis Rheumatol, 68(12), 2945-2952. https://doi.org/10.1002/art.39812 PMID: 27428559. PMCID: PMC5541999.
A role for plasma cell targeting agents in immune tolerance induction in autoimmune disease and antibody responses to therapeutic proteins
Rosenberg AS, Pariser AR, Diamond B, Yao L, Turka LA, Lacana E, Kishnani PS
Associated Clinical Trial(s):
Rosenberg AS, Pariser AR, Diamond B, Yao L, Turka LA, Lacana E, Kishnani PS (2016). A role for plasma cell targeting agents in immune tolerance induction in autoimmune disease and antibody responses to therapeutic proteins. Clin Immunol, 165, 55-9. https://doi.org/10.1016/j.clim.2016.02.009 PMID: 26928739.
International Society for Cellular Therapy perspective on immune functional assays for mesenchymal stromal cells as potency release criterion for advanced phase clinical trials
Galipeau J, Krampera M, Barrett J, Dazzi F, Deans RJ, DeBruijn J, Dominici M, Fibbe WE, Gee AP, Gimble JM, Hematti P, Koh MB, LeBlanc K, Martin I, McNiece IK, Mendicino M, Oh S, Ortiz L, Phinney DG, Planat V, Shi Y, Stroncek DF, Viswanathan S, Weiss DJ, Sensebe L
Associated Clinical Trial(s):
Galipeau J, Krampera M, Barrett J, Dazzi F, Deans RJ, DeBruijn J, Dominici M, Fibbe WE, Gee AP, Gimble JM, Hematti P, Koh MB, LeBlanc K, Martin I, McNiece IK, Mendicino M, Oh S, Ortiz L, Phinney DG, Planat V, Shi Y, Stroncek DF, Viswanathan S, Weiss DJ, Sensebe L (2016). International Society for Cellular Therapy perspective on immune functional assays for mesenchymal stromal cells as potency release criterion for advanced phase clinical trials. Cytotherapy, 18(2), 151-9. https://doi.org/10.1016/j.jcyt.2015.11.008 PMID: 26724220. PMCID: PMC4745114.
Factors Determining the Clinical Utility of Serial Measurements of Antineutrophil Cytoplasmic Antibodies Targeting Proteinase 3
Fussner LA, Hummel AM, Schroeder DR, Silva F, Cartin-Ceba R, Snyder MR, Hoffman GS, Kallenberg CG, Langford CA, Merkel PA, Monach PA, Seo P, Spiera RF, William St Clair E, Tchao NK, Stone JH, Specks U, Rituximab in ANCA-Associated Vasculitis-Immune Tolerance Network Research Group
Associated Clinical Trial(s):
Fussner LA, Hummel AM, Schroeder DR, Silva F, Cartin-Ceba R, Snyder MR, Hoffman GS, Kallenberg CG, Langford CA, Merkel PA, Monach PA, Seo P, Spiera RF, William St Clair E, Tchao NK, Stone JH, Specks U, Rituximab in ANCA-Associated Vasculitis-Immune Tolerance Network Research Group (2016). Factors Determining the Clinical Utility of Serial Measurements of Antineutrophil Cytoplasmic Antibodies Targeting Proteinase 3. Arthritis Rheumatol, 68(7), 1700-10. https://doi.org/10.1002/art.39637 PMID: 26882078. PMCID: PMC7137903.
Vitamin D in clinically isolated syndrome: evidence for possible neuroprotection
Mowry EM, Pelletier D, Gao Z, Howell MD, Zamvil SS, Waubant E
Associated Clinical Trial(s):
Mowry EM, Pelletier D, Gao Z, Howell MD, Zamvil SS, Waubant E (2016). Vitamin D in clinically isolated syndrome: evidence for possible neuroprotection. Eur J Neurol, 23(2), 327-32. https://doi.org/10.1111/ene.12844 PMID: 26518224.
Clinical outcomes of treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis based on ANCA type
Unizony S, Villarreal M, Miloslavsky EM, Lu N, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CM, St Clair EW, Ikle D, Tchao NK, Ding L, Brunetta P, Choi HK, Monach PA, Fervenza F, Stone JH, Specks U, RAVE-ITN Research Group
Associated Clinical Trial(s):
Unizony S, Villarreal M, Miloslavsky EM, Lu N, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CM, St Clair EW, Ikle D, Tchao NK, Ding L, Brunetta P, Choi HK, Monach PA, Fervenza F, Stone JH, Specks U, RAVE-ITN Research Group (2016). Clinical outcomes of treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis based on ANCA type. Ann Rheum Dis, 75(6), 1166-9. https://doi.org/10.1136/annrheumdis-2015-208073 PMID: 26621483. PMCID: PMC4908815.
Prevention of food allergy
du Toit G, Tsakok T, Lack S, Lack G
Associated Clinical Trial(s):
du Toit G, Tsakok T, Lack S, Lack G (2016). Prevention of food allergy. J Allergy Clin Immunol, 137(4), 998-1010. https://doi.org/10.1016/j.jaci.2016.02.005 PMID: 27059727.
