Abstract
Background The For Angioedema Subcutaneous Treatment (FAST)-2, a phase III, double-blind, randomized, multicenter, placebo-controlled study (ClinicalTrials.gov identifier: NCT00500656), established the efficacy and safety of single injections of icatibant, a bradykinin B2 receptor antagonist, in the treatment of hereditary angioedema (HAE) attacks. Here, we evaluate the efficacy and safety of repeated treatment with icatibant in adult patients experiencing HAE attacks during the FAST-2 open-label extension (OLE) phase. Methods Patients completing the controlled phase were eligible to participate in the OLE phase and receive open-label icatibant (30 mg subcutaneously) for the treatment of cutaneous, abdominal, and/or laryngeal HAE attack(s) severe enough to warrant treatment. Time to onset of symptom relief was calculated for each attack. Descriptive analyses (median, 95% CIs) were performed for all attacks; post hoc analyses were conducted in patients with at least five icatibant-treated attacks throughout the FAST-2 OLE phase. Safety was also monitored. Results Fifty-four patients received icatibant for 374 attacks (176 cutaneous, 168 abdominal, and 30 laryngeal). For cutaneous and/or abdominal attacks (attacks 2-5), the median times to onset of symptom relief ranged between 2.0 and 2.5 h. For all laryngeal attacks, the median times to regression (start of improvement) of symptoms ranged between 0.3 and 4.0 h. Post hoc analyses showed that the overall median time to onset of symptom relief was 2.0 h. Overall, 89.8% of attacks resolved with a single icatibant injection. No drug-related serious adverse events were reported. Conclusions These findings have demonstrated the efficacy and safety of repeated icatibant treatment for HAE attacks.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1452-1459 |
| Number of pages | 8 |
| Journal | Allergy: European Journal of Allergy and Clinical Immunology |
| Volume | 68 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 2013 |
| Externally published | Yes |
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Keywords
- bradykinin B receptor antagonist
- For Angioedema Subcutaneous Treatment-2 (FAST-2)
- hereditary angioedema
- icatibant
- open-label extension phase
ASJC Scopus subject areas
- Immunology
- Immunology and Allergy
Cite this
Repeat treatment with icatibant for multiple hereditary angioedema attacks : FAST-2 open-label study. / Baş, M.; Greve, J.; Hoffmann, T. K.; Reshef, A.; Aberer, W.; Maurer, M.; Kivity, S.; Farkas, H.; Floccard, B.; Arcoleo, F.; Martin, L.; Sitkauskiene, B.; Bouillet, L.; Schmid-Grendelmeier, P.; Li, Huamin; Zanichelli, A.
In: Allergy: European Journal of Allergy and Clinical Immunology, Vol. 68, No. 11, 11.2013, p. 1452-1459.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Repeat treatment with icatibant for multiple hereditary angioedema attacks
T2 - FAST-2 open-label study
AU - Baş, M.
AU - Greve, J.
AU - Hoffmann, T. K.
AU - Reshef, A.
AU - Aberer, W.
AU - Maurer, M.
AU - Kivity, S.
AU - Farkas, H.
AU - Floccard, B.
AU - Arcoleo, F.
AU - Martin, L.
AU - Sitkauskiene, B.
AU - Bouillet, L.
AU - Schmid-Grendelmeier, P.
AU - Li, Huamin
AU - Zanichelli, A.
PY - 2013/11
Y1 - 2013/11
N2 - Background The For Angioedema Subcutaneous Treatment (FAST)-2, a phase III, double-blind, randomized, multicenter, placebo-controlled study (ClinicalTrials.gov identifier: NCT00500656), established the efficacy and safety of single injections of icatibant, a bradykinin B2 receptor antagonist, in the treatment of hereditary angioedema (HAE) attacks. Here, we evaluate the efficacy and safety of repeated treatment with icatibant in adult patients experiencing HAE attacks during the FAST-2 open-label extension (OLE) phase. Methods Patients completing the controlled phase were eligible to participate in the OLE phase and receive open-label icatibant (30 mg subcutaneously) for the treatment of cutaneous, abdominal, and/or laryngeal HAE attack(s) severe enough to warrant treatment. Time to onset of symptom relief was calculated for each attack. Descriptive analyses (median, 95% CIs) were performed for all attacks; post hoc analyses were conducted in patients with at least five icatibant-treated attacks throughout the FAST-2 OLE phase. Safety was also monitored. Results Fifty-four patients received icatibant for 374 attacks (176 cutaneous, 168 abdominal, and 30 laryngeal). For cutaneous and/or abdominal attacks (attacks 2-5), the median times to onset of symptom relief ranged between 2.0 and 2.5 h. For all laryngeal attacks, the median times to regression (start of improvement) of symptoms ranged between 0.3 and 4.0 h. Post hoc analyses showed that the overall median time to onset of symptom relief was 2.0 h. Overall, 89.8% of attacks resolved with a single icatibant injection. No drug-related serious adverse events were reported. Conclusions These findings have demonstrated the efficacy and safety of repeated icatibant treatment for HAE attacks.
AB - Background The For Angioedema Subcutaneous Treatment (FAST)-2, a phase III, double-blind, randomized, multicenter, placebo-controlled study (ClinicalTrials.gov identifier: NCT00500656), established the efficacy and safety of single injections of icatibant, a bradykinin B2 receptor antagonist, in the treatment of hereditary angioedema (HAE) attacks. Here, we evaluate the efficacy and safety of repeated treatment with icatibant in adult patients experiencing HAE attacks during the FAST-2 open-label extension (OLE) phase. Methods Patients completing the controlled phase were eligible to participate in the OLE phase and receive open-label icatibant (30 mg subcutaneously) for the treatment of cutaneous, abdominal, and/or laryngeal HAE attack(s) severe enough to warrant treatment. Time to onset of symptom relief was calculated for each attack. Descriptive analyses (median, 95% CIs) were performed for all attacks; post hoc analyses were conducted in patients with at least five icatibant-treated attacks throughout the FAST-2 OLE phase. Safety was also monitored. Results Fifty-four patients received icatibant for 374 attacks (176 cutaneous, 168 abdominal, and 30 laryngeal). For cutaneous and/or abdominal attacks (attacks 2-5), the median times to onset of symptom relief ranged between 2.0 and 2.5 h. For all laryngeal attacks, the median times to regression (start of improvement) of symptoms ranged between 0.3 and 4.0 h. Post hoc analyses showed that the overall median time to onset of symptom relief was 2.0 h. Overall, 89.8% of attacks resolved with a single icatibant injection. No drug-related serious adverse events were reported. Conclusions These findings have demonstrated the efficacy and safety of repeated icatibant treatment for HAE attacks.
KW - bradykinin B receptor antagonist
KW - For Angioedema Subcutaneous Treatment-2 (FAST-2)
KW - hereditary angioedema
KW - icatibant
KW - open-label extension phase
UR - http://www.scopus.com/inward/record.url?scp=84887440357&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84887440357&partnerID=8YFLogxK
U2 - 10.1111/all.12244
DO - 10.1111/all.12244
M3 - Article
C2 - 24111645
AN - SCOPUS:84887440357
VL - 68
SP - 1452
EP - 1459
JO - Allergy: European Journal of Allergy and Clinical Immunology
JF - Allergy: European Journal of Allergy and Clinical Immunology
SN - 0105-4538
IS - 11
ER -