Subcutaneous Icatibant for the Treatment of Hereditary Angioedema Attacks: Comparison of Home Self-Administration with Administration at a Medical Facility.
BACKGROUND
Hereditary angioedema (HAE) is a life-threatening disorder characterized by recurrent angioedema. Icatibant, a subcutaneous bradykinin-B2-receptor antagonist, is an effective on-demand therapy. Data outside the United States suggest that self-administration is tolerated and patient-preferred compared with administration by health care professionals at medical facilities (HCP-administration).


OBJECTIVE
A prospective, multicenter study was conducted in the United States to compare icatibant self-administration and HCP-administration.


METHODS
Subjects 18 years or older with type I or II HAE were recruited. The first 2 HAE attacks after enrollment were treated at medical facilities. Subjects were instructed by a health care professional on self-administration during icatibant treatment for the second HAE attack. Icatibant was self-administered for all subsequent attacks. For each treated HAE attack, efficacy, safety, and tolerability data were recorded.


RESULTS
Nineteen patients with HAE received icatibant for 79 distinct HAE attacks. Mean attack duration was significantly shorter with self-administration (n = 50; 547 ± 510 minutes) than with HCP-administration (n = 29; 968 ± 717 minutes; P = .006). Mean time to treatment was significantly shorter with self-administration (143 ± 226 minutes) than with HCP-administration (361 ± 503 minutes; P < .0001). Shorter times to treatment were associated with shorter time from treatment to symptom resolution (r = 0.35; P = .02). Improvements in visual analog scale score and patient symptom score from pretreatment to 4 hours postinjection were comparable between self-administration and HCP-administration. There were no serious adverse events or discontinuations due to adverse events with self-administration or HCP-administration.


CONCLUSIONS
Icatibant self-administration shortened attack duration and time to treatment, with no difference in safety or local tolerability compared with HCP-administration. These findings support icatibant as an effective on-demand option for home-based treatment.
Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Mass. Electronic address: iris.m.otani@gmail.com.
Iris M
IM
Otani
Allergy Asthma Research Associates Research Center, Dallas, Texas; Allergy and Asthma Specialists, Dallas, Texas.
William R
WR
Lumry
Biostatistics Core, Center for Clinical Investigation, Department of Medicine, Brigham and Women's Hospital, Boston, Mass.
Shelley
S
Hurwitz
Institute for Asthma and Allergy, Chevy Chase, Md.
Huamin Henry
HH
Li
Division of Pulmonary, Allergy and Critical Care, Department of Medicine and Pediatrics, Penn State University, Hershey, Pa.
Timothy J
TJ
Craig
Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Mass.
Niki S
NS
Holtzman
Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Mass.
Matthew I
MI
Iandoli
Allergy Asthma Research Associates Research Center, Dallas, Texas; Allergy and Asthma Specialists, Dallas, Texas.
Julie
J
Tucker
Division of Rheumatology, Allergy, and Immunology, Department of Medicine, University of California, San Diego, La Jolla, Calif.
Marc A
MA
Riedl
Division of Rheumatology, Allergy, and Immunology, Department of Medicine, University of California, San Diego, La Jolla, Calif.
Bruce L
BL
Zuraw
Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Mass.
Aleena
A
Banerji
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D054179:Angioedemas, Hereditary / Q000188:drug therapy* / Q000453:epidemiology; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D001920:Bradykinin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D065094:Bradykinin B2 Receptor Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006282:Health Personnel; D006699:Home Care Services; D006801:Humans; D007279:Injections, Subcutaneous; D008875:Middle Aged; D057240:Patient Preference; D011446:Prospective Studies; D012646:Self Administration; D061665:Time-to-Treatment / Q000706:statistics & numerical data; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D064232:Visual Analog Scale; D055815:Young Adult
D000894:Anti-Inflammatory Agents, Non-Steroidal; D065094:Bradykinin B2 Receptor Antagonists; C065679:icatibant; D001920:Bradykinin
Bradykinin-receptor antagonist; Hereditary angioedema; Home-based treatment; Icatibant