Comparison · NCT03331835-866554f8
Brodalumab vs Fumaric Acid Esters: PSI Total Score of 0 at Week 24
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Brodalumab vs Fumaric Acid Esters: PSI Total Score of 0 at Week 24. Trial comparisons, record NCT03331835-866554f8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03331835-866554f8
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.217 | 0.0966 | 0.419 | wilson | |
| Risk in group 2 | 0.2 | 0.0705 | 0.452 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0174 | -0.262 | 0.257 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.304 | 3.89 | log | |
| Odds ratio, group 1 over group 2 | 1.11 | 0.223 | 5.54 | log | |
| Number needed to treat, for one more participant with the outcome on Brodalumab than on Fumaric Acid Esters | 57.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Brodalumab | Subcutaneous (s.c.) brodalumab 210 mg once weekly at Weeks 0, 1, and 2, and 210 mg s.c. every 2 weeks. | 5 | 23 | OG000 |
| Group 2 | Fumaric Acid Esters | Oral fumaric acid esters up to 240 mg 3 times daily (TID). | 3 | 15 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- PSI Total Score of 0 at Week 24
- Description
The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score \>1. Symptom-free day is defined as having daily total PSI of 0 on that day.
- Time frame
- Week 24
- Population
- PSI data was missing for many participants at baseline and Week 24. For this reason, no statistical analysis was performed. The data shown is therefore descriptive data.
Source ClinicalTrials.gov
Trial
- Title
- A Trial Comparing the Efficacy of Subcutaneous Injections of Brodalumab to Oral Administrations of Fumaric Acid Esters in Adults With Moderate to Severe Plaque Psoriasis
- NCT number
- NCT03331835
- Phases
- PHASE4
- Conditions
- Psoriasis Vulgaris
- Interventions
- Brodalumab, Fumaric acid esters
- Lead sponsor
- LEO Pharma
- Results first posted
- 2020-02-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03331835?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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