INDICATION: QUZYTTIR is indicated for the treatment of acute urticaria in adults and children 6 months of age and older. Limitations of Use: QUZYTTIR is not recommended in pediatric patients <6 years of age with impaired renal or hepatic function.

The efficacy of QUZYTTIR was
demonstrated in a phase 3 clinical study1

Blue squiggly background

QUZYTTIR's efficacy in reducing pruritis was demonstrated in a phase 3, non-inferiority study comparing QUZYTTIR to intravenous diphenhydramine (IV DPH) as an active control1

Phase 3 study design1

Horizontal series of three consecutive colored boxes in which the study design is stated followed by the primary efficacy endpoints and key secondary endpoints. Vertical series of three consecutive colored boxes in which the study design is stated followed by the primary efficacy endpoints and key secondary endpoints.
Select inclusion and exclusion criteria for QUZYTTIR phase 3 study2
Inclusion criteria:
  • Patients with a diagnosis of acute urticaria, with or without angioedema, in need of an antihistamine to alleviate symptoms
  • Subjects with a patient-rated pruritus score of ≥1
  • In patients with anaphylaxis, presence of acute urticaria after anaphylaxis symptoms had been alleviated
Exclusion criteria:
  • Any antihistamine (H1 or H2 antagonist) within the past 2 hours
  • Steroids within the past 4 hours to manage an acute allergic reaction
  • Epinephrine within the past 20 minutes

Urticaria, or hives (sometimes referred to as welts or wheals)3,4

Image of a person’s arm with urticaria, or hives

Phase 3: Primary endpoint

QUZYTTIR demonstrated efficacy in reducing pruritus1 Patient-rated pruritus score change from baseline at 2 hours (primary endpoint)1
Bar graph of mean change in patient-rated pruritis score from baseline at 2 hours, showing in the QUZYTTIR 10 milligram injection group, n=127, a mean change of -1.61 from a baseline of 2.20, and showing in the diphenhydramine 50 milligram injection group, n=135, a mean change of -1.50 from a baseline of 2.19. Sixty-three precent of patients in the study were female, with a mean age of 39 years for both treatment arms. Bar graph of mean change in patient-rated pruritis score from baseline at 2 hours, showing in the QUZYTTIR 10 milligram injection group, n=127, a mean change of -1.61 from a baseline of 2.20, and showing in the diphenhydramine 50 milligram injection group, n=135, a mean change of -1.50 from a baseline of 2.19. Sixty-three precent of patients in the study were female, with a mean age of 39 years for both treatment arms.
The majority of patients were female (63%), with a mean age of 39 years for both treatment arms.1
  • Adjusted treatment difference (least squares estimated treatment difference [95% CI]) 0.06 (-0.28, 0.40).*†
  • Unadjusted treatment difference is 0.11.
  • Last observation carried forward; intent-to-treat population.
  • Pruritus was graded on a severity score of 0 to 3 with 0=no pruritus, 1=mild, 2=moderate, and 3=severe.
  • * Model included treatment as a fixed effect, site as a random effect, and baseline pruritus score as a covariate.
  • †Non-inferiority met statistically; lower bound of 95% CI > -0.50.
  • CI=confidence interval.
  • Rapid onset and 24-hour duration of action for QUZYTTIR1‡
  • Time to Cmax: 3.6 minutes with 5 mg and 1.8 minutes with 10 mg
  • Drug activity persists for at least 24 hours
  • ‡ Mean Cmax: 495 ng/mL with 5 mg and 1344 ng/mL with 10 mg.

Phase 3: Secondary endpoints

Fewer return visits and shorter stays in the ED/clinic1,2,5 Two key secondary endpoints:
Return visits The need to return to any ED or clinic after patient discharge:

In the phase 3 trial, the proportion of patients returning to any ED or clinic was lower in the QUZYTTIR treatment group (6%) compared to the DPH treatment group (14%). There were more than twice as many return visits with DPH than with QUZYTTIR.1

Time at ED/clinic Time spent in the treatment center (time from treatment administration to readiness for discharge):

In the phase 3 trial, the time spent in the treatment center was shorter in the QUZYTTIR treatment group (1.7 mean hours) compared to the DPH treatment group (2.1 mean hours).1

Patient-rated sedation1 Secondary endpoint:
Patient-rated sedation scores were collected for all study participants (N=262). Sedation was rated on a 0- to 3-point scale (0=none, 3=severe). Assessment of sedation was completed at baseline and time points of 1 hour, 2 hours, and readiness for discharge. Patients reported less sedation with QUZYTTIR (n=127) vs DPH (n=135) at all assessed time points.1
Icon of a handshake
Request a representative

Get more information about QUZYTTIR and resources available to support your patients.

Request a rep
×

Healthcare Professionals

The information contained in this section of the site is intended for US Healthcare Professionals only. Click Continue if you are a US Healthcare Professional.

Continue Cancel