C1 esterase inhibitor concentrate in 1085 Hereditary Angioedema attacks - Final results of the I.M.P.A.C.T.2 study

T. J. Craig, Againdra K. Bewtra, S. L. Bahna, D. Hurewitz, L. C. Schneider, R. J. Levy, J. N. Moy, J. Offenberger, K. W. Jacobson, W. H. Yang, F. Eidelman, G. Janss, F. R. Packer, M. A. Rojavin, T. Machnig, H. O. Keinecke, R. L. Wasserman

Research output: Contribution to journalArticle

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Abstract

Background: The placebo-controlled study International Multicentre Prospective Angioedema C1-INH Trial 1 (I.M.P.A.C.T.1) demonstrated that 20 U/kg C1 esterase inhibitor (C1-INH) concentrate (Berinert®; CSL Behring, Marburg, Germany) is effective in treating acute abdominal and facial Hereditary Angioedema (HAE) attacks. Methods: I.M.PA.CT.2 was an open-label extension study of I.M.P.A.C.T.1 to evaluate the safety and efficacy of long-term treatment with 20 U/kg C1-INH for successive HAE attacks at any body location. Efficacy outcomes included patient-reported time to onset of symptom relief (primary) and time to complete resolution of all symptoms (secondary), analysed on a per-patient and per-attack basis. Safety assessments included adverse events, vital signs, viral safety and anti-C1-INH antibodies. Results: During a median study duration of 24 months, 1085 attacks were treated in 57 patients (10-53 years of age). In the per-patient analysis, the median time to onset of symptom relief was 0.46 h and was similar for all types of attacks (0.39-0.48 h); the median time to complete resolution of symptoms was 15.5 h (shortest for laryngeal attacks: 5.8 h; 12.8-26.6 h for abdominal, peripheral and facial attacks). Demographic factors, type of HAE, intensity of attacks, time to treatment, use of androgens and presence of anti-C1-INH antibodies had no clinically relevant effect on the efficacy outcomes. There were no treatment-related safety concerns. No inhibitory anti-C1-INH antibodies were detected in any patient. Conclusions: A single dose of 20 U/kg C1-INH concentrate is safe and provides reliable efficacy in the long-term treatment of successive HAE attacks at any body location.

Original languageEnglish
Pages (from-to)1604-1611
Number of pages8
JournalAllergy: European Journal of Allergy and Clinical Immunology
Volume66
Issue number12
DOIs
StatePublished - Dec 2011

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Complement C1 Inhibitor Protein
Hereditary Angioedemas
Safety
Angioedema
Multicenter Studies
Antibodies
Vital Signs
Therapeutics
Androgens
Germany
Placebos
Demography

All Science Journal Classification (ASJC) codes

  • Immunology
  • Immunology and Allergy

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C1 esterase inhibitor concentrate in 1085 Hereditary Angioedema attacks - Final results of the I.M.P.A.C.T.2 study. / Craig, T. J.; Bewtra, Againdra K.; Bahna, S. L.; Hurewitz, D.; Schneider, L. C.; Levy, R. J.; Moy, J. N.; Offenberger, J.; Jacobson, K. W.; Yang, W. H.; Eidelman, F.; Janss, G.; Packer, F. R.; Rojavin, M. A.; Machnig, T.; Keinecke, H. O.; Wasserman, R. L.

In: Allergy: European Journal of Allergy and Clinical Immunology, Vol. 66, No. 12, 12.2011, p. 1604-1611.

Research output: Contribution to journalArticle

Craig, TJ, Bewtra, AK, Bahna, SL, Hurewitz, D, Schneider, LC, Levy, RJ, Moy, JN, Offenberger, J, Jacobson, KW, Yang, WH, Eidelman, F, Janss, G, Packer, FR, Rojavin, MA, Machnig, T, Keinecke, HO & Wasserman, RL 2011, 'C1 esterase inhibitor concentrate in 1085 Hereditary Angioedema attacks - Final results of the I.M.P.A.C.T.2 study', Allergy: European Journal of Allergy and Clinical Immunology, vol. 66, no. 12, pp. 1604-1611. https://doi.org/10.1111/j.1398-9995.2011.02702.x
Craig, T. J. ; Bewtra, Againdra K. ; Bahna, S. L. ; Hurewitz, D. ; Schneider, L. C. ; Levy, R. J. ; Moy, J. N. ; Offenberger, J. ; Jacobson, K. W. ; Yang, W. H. ; Eidelman, F. ; Janss, G. ; Packer, F. R. ; Rojavin, M. A. ; Machnig, T. ; Keinecke, H. O. ; Wasserman, R. L. / C1 esterase inhibitor concentrate in 1085 Hereditary Angioedema attacks - Final results of the I.M.P.A.C.T.2 study. In: Allergy: European Journal of Allergy and Clinical Immunology. 2011 ; Vol. 66, No. 12. pp. 1604-1611.
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abstract = "Background: The placebo-controlled study International Multicentre Prospective Angioedema C1-INH Trial 1 (I.M.P.A.C.T.1) demonstrated that 20 U/kg C1 esterase inhibitor (C1-INH) concentrate (Berinert{\circledR}; CSL Behring, Marburg, Germany) is effective in treating acute abdominal and facial Hereditary Angioedema (HAE) attacks. Methods: I.M.PA.CT.2 was an open-label extension study of I.M.P.A.C.T.1 to evaluate the safety and efficacy of long-term treatment with 20 U/kg C1-INH for successive HAE attacks at any body location. Efficacy outcomes included patient-reported time to onset of symptom relief (primary) and time to complete resolution of all symptoms (secondary), analysed on a per-patient and per-attack basis. Safety assessments included adverse events, vital signs, viral safety and anti-C1-INH antibodies. Results: During a median study duration of 24 months, 1085 attacks were treated in 57 patients (10-53 years of age). In the per-patient analysis, the median time to onset of symptom relief was 0.46 h and was similar for all types of attacks (0.39-0.48 h); the median time to complete resolution of symptoms was 15.5 h (shortest for laryngeal attacks: 5.8 h; 12.8-26.6 h for abdominal, peripheral and facial attacks). Demographic factors, type of HAE, intensity of attacks, time to treatment, use of androgens and presence of anti-C1-INH antibodies had no clinically relevant effect on the efficacy outcomes. There were no treatment-related safety concerns. No inhibitory anti-C1-INH antibodies were detected in any patient. Conclusions: A single dose of 20 U/kg C1-INH concentrate is safe and provides reliable efficacy in the long-term treatment of successive HAE attacks at any body location.",
author = "Craig, {T. J.} and Bewtra, {Againdra K.} and Bahna, {S. L.} and D. Hurewitz and Schneider, {L. C.} and Levy, {R. J.} and Moy, {J. N.} and J. Offenberger and Jacobson, {K. W.} and Yang, {W. H.} and F. Eidelman and G. Janss and Packer, {F. R.} and Rojavin, {M. A.} and T. Machnig and Keinecke, {H. O.} and Wasserman, {R. L.}",
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T1 - C1 esterase inhibitor concentrate in 1085 Hereditary Angioedema attacks - Final results of the I.M.P.A.C.T.2 study

AU - Craig, T. J.

AU - Bewtra, Againdra K.

AU - Bahna, S. L.

AU - Hurewitz, D.

AU - Schneider, L. C.

AU - Levy, R. J.

AU - Moy, J. N.

AU - Offenberger, J.

AU - Jacobson, K. W.

AU - Yang, W. H.

AU - Eidelman, F.

AU - Janss, G.

AU - Packer, F. R.

AU - Rojavin, M. A.

AU - Machnig, T.

AU - Keinecke, H. O.

AU - Wasserman, R. L.

PY - 2011/12

Y1 - 2011/12

N2 - Background: The placebo-controlled study International Multicentre Prospective Angioedema C1-INH Trial 1 (I.M.P.A.C.T.1) demonstrated that 20 U/kg C1 esterase inhibitor (C1-INH) concentrate (Berinert®; CSL Behring, Marburg, Germany) is effective in treating acute abdominal and facial Hereditary Angioedema (HAE) attacks. Methods: I.M.PA.CT.2 was an open-label extension study of I.M.P.A.C.T.1 to evaluate the safety and efficacy of long-term treatment with 20 U/kg C1-INH for successive HAE attacks at any body location. Efficacy outcomes included patient-reported time to onset of symptom relief (primary) and time to complete resolution of all symptoms (secondary), analysed on a per-patient and per-attack basis. Safety assessments included adverse events, vital signs, viral safety and anti-C1-INH antibodies. Results: During a median study duration of 24 months, 1085 attacks were treated in 57 patients (10-53 years of age). In the per-patient analysis, the median time to onset of symptom relief was 0.46 h and was similar for all types of attacks (0.39-0.48 h); the median time to complete resolution of symptoms was 15.5 h (shortest for laryngeal attacks: 5.8 h; 12.8-26.6 h for abdominal, peripheral and facial attacks). Demographic factors, type of HAE, intensity of attacks, time to treatment, use of androgens and presence of anti-C1-INH antibodies had no clinically relevant effect on the efficacy outcomes. There were no treatment-related safety concerns. No inhibitory anti-C1-INH antibodies were detected in any patient. Conclusions: A single dose of 20 U/kg C1-INH concentrate is safe and provides reliable efficacy in the long-term treatment of successive HAE attacks at any body location.

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