Chronic Urticaria
Conditions
Keywords
Chronic urticaria, omalizumab, thyroperoxidase, IgE
Brief summary
This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.
Interventions
DRUGOmalizumab 75-375 mg
Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection.
Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg placebo to omalizumab upon reconstitution with 1.4 ml sterile water for injection.
DRUGLoratadine
All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.
DRUGClemastine
All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Males or females from 18-70 years of age * Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700 IU/mL * Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to randomization or time of pre-screening * Diagnosis of moderate to severe chronic urticaria * Subject's current episode of chronic urticaria according to the European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum (EAACI/GA2LEN/EDF) guideline at the time of screening * Current episode of chronic urticaria has not responded to the approved marketed dose of antihistamine for 2 weeks or longer * Urticaria activity score (UAS) ≥ 0 at any of the 7 days of the first section of the screening period * UAS7 ≥ 10 at the time of randomization
Exclusion criteria
* Females of child-bearing potential or breast feeding * Present or past medical conditions that could have interfered with the study results * Randomized into any other omalizumab study or who had received omalizumab * Received investigational drugs within 30 days of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24) | Baseline to end of the study (Week 24) | The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24) | Baseline to the end of the study (Week 24) | The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. A higher score indicates worse disease. AUC was calculated from daily UASs where no urticaria medication was taken using the trapezoidal rule. The standardized AUC UAS was calculated as the sum of trapezoids divided by the length of time. |
| Use of Concomitant and Rescue Medications | At Weeks 4, 8, 12, 16, 20, and 24 | Data was collected from the patients' diaries about the number of clemastine and loratadine pills taken during the last 7 days of each month of the study. |
| Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24) | Baseline to the end of the study (Week 24) | The DLQI is a dermatology-specific quality of life (QoL) questionnaire designed for use in patients over 16 years of age. Patients are asked to respond to each of 10 questions on a 4-point Likert scale in regard to how much their skin problem has affected their life over the last week (0=not at all, 1=a little, 2=a lot, 3=very much). The overall (total) DLQI score (range=0 to 30) is calculated by summing the scores of all 10 questions. The higher the score, the more QoL is impaired. A negative change score (Week 24 score minus Baseline score) indicates improvement. |
| Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | At the end of the study (Week 24) | Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study. |
| Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline to the end of the study (Week 24) | The CU-Q2oL (German version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It has 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1=not at all to 5=very much). Each domain and the overall (total) scores are normalized to a scale of 1 to 100. A higher score indicates lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement. |
| Patient's Global Assessment of Their Chronic Urticaria Symptoms | At Baseline and at the end of the study (Week 24) | Patients made a global assessment of their chronic urticaria symptoms on a 4-point Likert scale (none, mild moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported. |
| Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | At Baseline and at the end of the study (Week 24) | The investigator made a global assessment of the patient's chronic urticaria symptoms on a 4-point Likert scale (none, mild, moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported. |
| Change in the Skindex Score From Baseline to the End of the Study (Week 24) | Baseline to the end of the study (Week 24) | Skindex is a 30-item questionnaire with 3 scores (functioning, emotions,symptoms) and a composite score (average scale score) that assesses the effects of skin disease on patients' quality of life (QoL). Item responses are standardized on a scale from 0 to 100. The mean of all 61 items was calculated. A higher score indicates a lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omalizumab 75-375 mg Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose. | 27 |
| Placebo to Omalizumab Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose. | 22 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative problem | 1 | 0 |
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Unsatisfactory therapeutic effect | 1 | 4 |
Baseline characteristics
| Characteristic | Omalizumab 75-375 mg | Placebo to Omalizumab | Total |
|---|---|---|---|
| Age Continuous | 39.1 years STANDARD_DEVIATION 9 | 42.3 years STANDARD_DEVIATION 15 | 40.5 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 27 | 12 / 22 |
| serious Total, serious adverse events | 0 / 27 | 2 / 22 |
Outcome results
Primary
Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement.
Time frame: Baseline to end of the study (Week 24)
Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omalizumab 75-375 mg | Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24) | -17.8 Units on a scale | Standard Deviation 10.52 |
| Placebo to Omalizumab | Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24) | -5.8 Units on a scale | Standard Deviation 11.52 |
Secondary
Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)
The CU-Q2oL (German version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It has 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1=not at all to 5=very much). Each domain and the overall (total) scores are normalized to a scale of 1 to 100. A higher score indicates lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.
Time frame: Baseline to the end of the study (Week 24)
Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Itching/embarrassment (N=27,22) | 58.1 Units on a scale | Standard Deviation 18.97 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Functioning (N=27,21) | 11.9 Units on a scale | Standard Deviation 22.43 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Swelling/eating (N=27,22) | 21.8 Units on a scale | Standard Deviation 20.17 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Itching/embarrassment (N=27,21) | 22.9 Units on a scale | Standard Deviation 29.42 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Total score (N=27,22) | 39.5 Units on a scale | Standard Deviation 16.34 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Total score (N=27,21) | 18.5 Units on a scale | Standard Deviation 22.66 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Mental status (N=27,22) | 42.6 Units on a scale | Standard Deviation 21.72 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: Limits looks (N=27,20) | -14.4 Units on a scale | Standard Deviation 24.69 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Limits looks (N=27,21) | 17.1 Units on a scale | Standard Deviation 20.26 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: Swelling/eating (N=27,21) | -11.3 Units on a scale | Standard Deviation 22.4 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Limits Looks (N=27,21) | 31.5 Units on a scale | Standard Deviation 23.86 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: Sleep (N=27,21) | -18.5 Units on a scale | Standard Deviation 27.05 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Functioning (N=27,22) | 36.0 Units on a scale | Standard Deviation 22.47 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: Mental status (N=27,21) | -16.7 Units on a scale | Standard Deviation 27.35 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Sleep (N=27,21) | 27.3 Units on a scale | Standard Deviation 29.73 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: Functioning (N=27,21) | -24.1 Units on a scale | Standard Deviation 23.94 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Sleep (N=27,22) | 45.8 Units on a scale | Standard Deviation 24.02 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: itching/embarrassmen (N=27,21) | -35.2 Units on a scale | Standard Deviation 32.71 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Mental status (N=27,21) | 25.9 Units on a scale | Standard Deviation 27.77 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: Total score (N=27,21) | -21.0 Units on a scale | Standard Deviation 21.97 |
| Omalizumab 75-375 mg | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Swelling/eating (N=27,21) | 10.4 Units on a scale | Standard Deviation 23.58 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: Total score (N=27,21) | -2.3 Units on a scale | Standard Deviation 14.14 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Limits Looks (N=27,21) | 34.5 Units on a scale | Standard Deviation 24.97 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Swelling/eating (N=27,22) | 26.7 Units on a scale | Standard Deviation 19.97 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Sleep (N=27,22) | 46.6 Units on a scale | Standard Deviation 23.91 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Mental status (N=27,22) | 42.4 Units on a scale | Standard Deviation 18.71 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Functioning (N=27,22) | 30.7 Units on a scale | Standard Deviation 15.88 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Itching/embarrassment (N=27,22) | 56.8 Units on a scale | Standard Deviation 14.8 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Baseline : Total score (N=27,22) | 38.9 Units on a scale | Standard Deviation 8.87 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Limits looks (N=27,21) | 23.2 Units on a scale | Standard Deviation 20.27 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Swelling/eating (N=27,21) | 27.4 Units on a scale | Standard Deviation 23.92 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Sleep (N=27,21) | 47.3 Units on a scale | Standard Deviation 27.36 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Mental status (N=27,21) | 40.1 Units on a scale | Standard Deviation 25.22 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Functioning (N=27,21) | 27.0 Units on a scale | Standard Deviation 20.73 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Itching/embarrassment (N=27,21) | 57.4 Units on a scale | Standard Deviation 22.41 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 : Total score (N=27,21) | 37.3 Units on a scale | Standard Deviation 16.22 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: Limits looks (N=27,20) | -9.4 Units on a scale | Standard Deviation 18.08 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: Swelling/eating (N=27,21) | -0.6 Units on a scale | Standard Deviation 18.74 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: Sleep (N=27,21) | -0.6 Units on a scale | Standard Deviation 23.13 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: Mental status (N=27,21) | -2.4 Units on a scale | Standard Deviation 19.57 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: Functioning (N=27,21) | -3.8 Units on a scale | Standard Deviation 21.08 |
| Placebo to Omalizumab | Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) | Week 24 - Baseline: itching/embarrassmen (N=27,21) | -0.9 Units on a scale | Standard Deviation 20.76 |
Secondary
Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)
The DLQI is a dermatology-specific quality of life (QoL) questionnaire designed for use in patients over 16 years of age. Patients are asked to respond to each of 10 questions on a 4-point Likert scale in regard to how much their skin problem has affected their life over the last week (0=not at all, 1=a little, 2=a lot, 3=very much). The overall (total) DLQI score (range=0 to 30) is calculated by summing the scores of all 10 questions. The higher the score, the more QoL is impaired. A negative change score (Week 24 score minus Baseline score) indicates improvement.
Time frame: Baseline to the end of the study (Week 24)
Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omalizumab 75-375 mg | Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24) | Baseline (N=27, 22) | 10.1 Units on a scale | Standard Deviation 6.04 |
| Omalizumab 75-375 mg | Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24) | Week 24 (N=27,21) | 3.7 Units on a scale | Standard Deviation 7.12 |
| Omalizumab 75-375 mg | Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24) | Week 24 minus Baseline (N=27,21) | -6.3 Units on a scale | Standard Deviation 8.36 |
| Placebo to Omalizumab | Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24) | Baseline (N=27, 22) | 9.8 Units on a scale | Standard Deviation 5.29 |
| Placebo to Omalizumab | Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24) | Week 24 (N=27,21) | 8.1 Units on a scale | Standard Deviation 6.11 |
| Placebo to Omalizumab | Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24) | Week 24 minus Baseline (N=27,21) | -1.5 Units on a scale | Standard Deviation 5.83 |
Secondary
Change in the Skindex Score From Baseline to the End of the Study (Week 24)
Skindex is a 30-item questionnaire with 3 scores (functioning, emotions,symptoms) and a composite score (average scale score) that assesses the effects of skin disease on patients' quality of life (QoL). Item responses are standardized on a scale from 0 to 100. The mean of all 61 items was calculated. A higher score indicates a lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.
Time frame: Baseline to the end of the study (Week 24)
Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omalizumab 75-375 mg | Change in the Skindex Score From Baseline to the End of the Study (Week 24) | Baseline (N=27,22) | 1.8 Units on a scale | Standard Deviation 0.69 |
| Omalizumab 75-375 mg | Change in the Skindex Score From Baseline to the End of the Study (Week 24) | Week 24 (N=27,21) | 0.9 Units on a scale | Standard Deviation 1 |
| Omalizumab 75-375 mg | Change in the Skindex Score From Baseline to the End of the Study (Week 24) | Week 24 minus Baseline (N=27,21) | -0.9 Units on a scale | Standard Deviation 0.89 |
| Placebo to Omalizumab | Change in the Skindex Score From Baseline to the End of the Study (Week 24) | Baseline (N=27,22) | 1.6 Units on a scale | Standard Deviation 0.53 |
| Placebo to Omalizumab | Change in the Skindex Score From Baseline to the End of the Study (Week 24) | Week 24 (N=27,21) | 1.5 Units on a scale | Standard Deviation 0.79 |
| Placebo to Omalizumab | Change in the Skindex Score From Baseline to the End of the Study (Week 24) | Week 24 minus Baseline (N=27,21) | -0.1 Units on a scale | Standard Deviation 0.61 |
Secondary
Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms
The investigator made a global assessment of the patient's chronic urticaria symptoms on a 4-point Likert scale (none, mild, moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.
Time frame: At Baseline and at the end of the study (Week 24)
Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab 75-375 mg | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Week 24: None | 18 Participants |
| Omalizumab 75-375 mg | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Baseline: Missing | 1 Participants |
| Omalizumab 75-375 mg | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Baseline: None | 1 Participants |
| Omalizumab 75-375 mg | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Baseline: Mild | 7 Participants |
| Omalizumab 75-375 mg | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Baseline: Moderate | 13 Participants |
| Omalizumab 75-375 mg | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Baseline: Severe | 5 Participants |
| Omalizumab 75-375 mg | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Week 24: Missing | 0 Participants |
| Omalizumab 75-375 mg | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Week 24: Mild | 6 Participants |
| Omalizumab 75-375 mg | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Week 24: Moderate | 1 Participants |
| Omalizumab 75-375 mg | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Week 24: Severe | 2 Participants |
| Placebo to Omalizumab | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Week 24: Mild | 9 Participants |
| Placebo to Omalizumab | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Week 24: None | 1 Participants |
| Placebo to Omalizumab | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Baseline: Severe | 7 Participants |
| Placebo to Omalizumab | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Baseline: Missing | 0 Participants |
| Placebo to Omalizumab | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Week 24: Severe | 7 Participants |
| Placebo to Omalizumab | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Baseline: None | 0 Participants |
| Placebo to Omalizumab | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Week 24: Missing | 1 Participants |
| Placebo to Omalizumab | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Baseline: Mild | 9 Participants |
| Placebo to Omalizumab | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Week 24: Moderate | 4 Participants |
| Placebo to Omalizumab | Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms | Baseline: Moderate | 6 Participants |
Secondary
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study
Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.
Time frame: At the end of the study (Week 24)
Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Erythemas - 10-50 | 1 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Erythemas - > 50 | 1 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Wheals - None | 19 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Wheals - < 10 | 3 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Wheals - 10-50 | 1 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Wheals - > 50 | 1 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Erythemas - None | 18 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Erythemas - < 10 | 4 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Pruritus - None | 16 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Pruritus - Mild | 4 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Pruritus - Moderate | 3 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Pruritus - Severe | 1 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Angioedema - None | 21 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Angioedema - Mild | 1 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Angioedema - Moderate | 0 Participants |
| Omalizumab 75-375 mg | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Angioedema - Severe | 2 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Angioedema - Severe | 1 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Erythemas - 10-50 | 4 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Pruritus - None | 2 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Angioedema - None | 8 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Wheals - None | 1 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Pruritus - Mild | 8 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Wheals - < 10 | 11 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Angioedema - Moderate | 1 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Wheals - 10-50 | 3 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Pruritus - Moderate | 3 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Wheals - > 50 | 1 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Angioedema - Mild | 6 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Erythemas - None | 4 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Pruritus - Severe | 3 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Erythemas - < 10 | 7 Participants |
| Placebo to Omalizumab | Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study | Erythemas - > 50 | 1 Participants |
Secondary
Patient's Global Assessment of Their Chronic Urticaria Symptoms
Patients made a global assessment of their chronic urticaria symptoms on a 4-point Likert scale (none, mild moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.
Time frame: At Baseline and at the end of the study (Week 24)
Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab 75-375 mg | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Baseline: No complaints | 3 Participants |
| Omalizumab 75-375 mg | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Week 24: Missing | 1 Participants |
| Omalizumab 75-375 mg | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Baseline: Moderate complaints | 13 Participants |
| Omalizumab 75-375 mg | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Week 24: No complaints | 16 Participants |
| Omalizumab 75-375 mg | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Week 24: Moderate complaints | 6 Participants |
| Omalizumab 75-375 mg | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Baseline: Maximum complaints | 0 Participants |
| Omalizumab 75-375 mg | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Week 24: Severe complaints | 3 Participants |
| Omalizumab 75-375 mg | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Baseline: Missing | 0 Participants |
| Omalizumab 75-375 mg | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Week 24: Maximum complaints | 1 Participants |
| Omalizumab 75-375 mg | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Baseline: Severe complaints | 11 Participants |
| Placebo to Omalizumab | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Week 24: Maximum complaints | 2 Participants |
| Placebo to Omalizumab | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Baseline: Severe complaints | 8 Participants |
| Placebo to Omalizumab | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Baseline: Maximum complaints | 1 Participants |
| Placebo to Omalizumab | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Week 24: No complaints | 3 Participants |
| Placebo to Omalizumab | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Baseline: Missing | 0 Participants |
| Placebo to Omalizumab | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Baseline: No complaints | 0 Participants |
| Placebo to Omalizumab | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Week 24: Missing | 1 Participants |
| Placebo to Omalizumab | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Week 24: Moderate complaints | 7 Participants |
| Placebo to Omalizumab | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Week 24: Severe complaints | 9 Participants |
| Placebo to Omalizumab | Patient's Global Assessment of Their Chronic Urticaria Symptoms | Baseline: Moderate complaints | 13 Participants |
Secondary
Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24)
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. A higher score indicates worse disease. AUC was calculated from daily UASs where no urticaria medication was taken using the trapezoidal rule. The standardized AUC UAS was calculated as the sum of trapezoids divided by the length of time.
Time frame: Baseline to the end of the study (Week 24)
Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omalizumab 75-375 mg | Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24) | 1.0 Units on a scale | Standard Deviation 1.28 |
| Placebo to Omalizumab | Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24) | 2.5 Units on a scale | Standard Deviation 1.23 |
Secondary
Use of Concomitant and Rescue Medications
Data was collected from the patients' diaries about the number of clemastine and loratadine pills taken during the last 7 days of each month of the study.
Time frame: At Weeks 4, 8, 12, 16, 20, and 24
Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omalizumab 75-375 mg | Use of Concomitant and Rescue Medications | Week 4 - clemastine (N=27,21) | 0.7 Pills | Standard Deviation 3.1 |
| Omalizumab 75-375 mg | Use of Concomitant and Rescue Medications | Week 4 - loratadine (N=27,22) | 1.3 Pills | Standard Deviation 2.51 |
| Omalizumab 75-375 mg | Use of Concomitant and Rescue Medications | Week 8 - clemastine (N=26,20) | 1.3 Pills | Standard Deviation 4.05 |
| Omalizumab 75-375 mg | Use of Concomitant and Rescue Medications | Week 8 - loratadine (N=26,21) | 1.2 Pills | Standard Deviation 2.45 |
| Omalizumab 75-375 mg | Use of Concomitant and Rescue Medications | Week 12 - clemastine (N=25,17) | 1.1 Pills | Standard Deviation 3.81 |
| Omalizumab 75-375 mg | Use of Concomitant and Rescue Medications | Week 12 - loratadine (N=25,19) | 1.2 Pills | Standard Deviation 2.33 |
| Omalizumab 75-375 mg | Use of Concomitant and Rescue Medications | Week 16 - clemastine (N=24,16) | 0.2 Pills | Standard Deviation 0.72 |
| Omalizumab 75-375 mg | Use of Concomitant and Rescue Medications | Week 16 - loratadine (N=24,17) | 0.6 Pills | Standard Deviation 1.56 |
| Omalizumab 75-375 mg | Use of Concomitant and Rescue Medications | Week 20 - clemastine (N=24,16) | 0.9 Pills | Standard Deviation 3.88 |
| Omalizumab 75-375 mg | Use of Concomitant and Rescue Medications | Week 20 - loratadine (N=24,17) | 0.5 Pills | Standard Deviation 1.47 |
| Omalizumab 75-375 mg | Use of Concomitant and Rescue Medications | Week 24 - clemastine (N=23,14) | 0.7 Pills | Standard Deviation 2.72 |
| Omalizumab 75-375 mg | Use of Concomitant and Rescue Medications | Week 24 - clemastine (N=23,16) | 0.3 Pills | Standard Deviation 1.11 |
| Placebo to Omalizumab | Use of Concomitant and Rescue Medications | Week 24 - clemastine (N=23,14) | 1.4 Pills | Standard Deviation 2.13 |
| Placebo to Omalizumab | Use of Concomitant and Rescue Medications | Week 4 - clemastine (N=27,21) | 3.7 Pills | Standard Deviation 5.3 |
| Placebo to Omalizumab | Use of Concomitant and Rescue Medications | Week 16 - clemastine (N=24,16) | 1.4 Pills | Standard Deviation 2.13 |
| Placebo to Omalizumab | Use of Concomitant and Rescue Medications | Week 4 - loratadine (N=27,22) | 4.2 Pills | Standard Deviation 2.61 |
| Placebo to Omalizumab | Use of Concomitant and Rescue Medications | Week 20 - loratadine (N=24,17) | 4.6 Pills | Standard Deviation 3.48 |
| Placebo to Omalizumab | Use of Concomitant and Rescue Medications | Week 8 - clemastine (N=26,20) | 2.4 Pills | Standard Deviation 3.69 |
| Placebo to Omalizumab | Use of Concomitant and Rescue Medications | Week 16 - loratadine (N=24,17) | 3.6 Pills | Standard Deviation 3 |
| Placebo to Omalizumab | Use of Concomitant and Rescue Medications | Week 8 - loratadine (N=26,21) | 4.2 Pills | Standard Deviation 2.62 |
| Placebo to Omalizumab | Use of Concomitant and Rescue Medications | Week 24 - clemastine (N=23,16) | 3.3 Pills | Standard Deviation 2.5 |
| Placebo to Omalizumab | Use of Concomitant and Rescue Medications | Week 12 - clemastine (N=25,17) | 1.8 Pills | Standard Deviation 3.8 |
| Placebo to Omalizumab | Use of Concomitant and Rescue Medications | Week 20 - clemastine (N=24,16) | 2.2 Pills | Standard Deviation 2.88 |
| Placebo to Omalizumab | Use of Concomitant and Rescue Medications | Week 12 - loratadine (N=25,19) | 3.3 Pills | Standard Deviation 2.64 |