This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis (NCT03010527), a non-randomized phase 2 study. The primary outcome is Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03010527 |
| Phase | Phase 2 |
| Condition | Chronic Plaque Psoriasis |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 217 |
| Arms in the primary outcome | n/a |
| Lead sponsor | UCB Biopharma SRL |
| Results posted | Yes |
2. Clinical Question
Population
Adults with moderate to severe chronic plaque psoriasis who entered the extension study are the population of interest. The safety analysis population included participants who received at least 1 dose of study medication in PS0011. The registry record lists enrollment of 217, but does not report the number in each analysis population beyond the safety-group counts.
Intervention
The study assessed continued treatment with bimekizumab in dosing regimens described as 64 mg Q4W, 160 mg Q4W, and 320 mg Q4W. For some participants, the regimen in PS0011 depended on their Week 12 PASI90 response and their previous study regimen. Participants who did not achieve PASI90 in some regimens were assigned to a higher dosing regimen.
Comparator
A placebo group was included. Its members were described as participants with a PASI90 response at Week 12 who had received placebo in PS0010 and entered PS0011. The registry identifies the extension study’s allocation as non-randomized, so the placebo and bimekizumab groups should not be treated as like-for-like randomized comparison groups.
Primary question
The primary endpoint concerns the incidence of treatment-emergent adverse events, adjusted for duration of exposure and expressed per 100 subject-years. It asks how often participants experienced these events relative to time at risk. The registry record does not report the numerical endpoint estimates or their confidence intervals, so the size and precision of the endpoint results cannot be described.
3. Trial Design
This was a Phase 2, multicenter, parallel-group extension study of bimekizumab in adults with moderate to severe chronic plaque psoriasis. The study was described as double-blind and placebo-controlled in its official title, and the registry lists quadruple masking. Its allocation is listed as non-randomized. These design features describe different aspects of the trial: masking concerns knowledge of assigned treatment, while allocation describes how participants entered treatment groups. The registry record does not say which roles were covered by the masking designation.
The extension followed PS0010, and treatment assignment in PS0011 was linked to prior treatment and Week 12 PASI90 response for some participants. Participants who had a PASI90 response and had received a particular bimekizumab regimen in PS0010 were to continue that regimen. Participants without that response in some regimens were assigned to a higher regimen. Participants initially randomized to bimekizumab regimens 3, 4, and 5 in PS0010 were to receive regimen 3 in PS0011. The placebo group consisted of participants with a Week 12 PASI90 response who had received placebo in PS0010.
This history matters when interpreting comparisons. The extension did not assign participants to bimekizumab or placebo through a new randomized allocation, and treatment groups were shaped by earlier treatment and response. The listed placebo group is therefore not a like-for-like control for the bimekizumab groups. A difference between groups, if reported, could not automatically be attributed to treatment alone.
The registry lists enrollment of 217 and a study duration of 48 weeks in the official title. The primary endpoint timeframe runs from baseline until the safety follow-up visit, up to Week 64. The study is marked completed. The registry record does not report the numerical primary endpoint results, the details of participant flow, or a statistical plan for comparing groups.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Participant Flow refers to the Full Analysis Set (FAS), which consisted of all enrolled participants who received at least 1 dose of the investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline of PS0011.
Overall Study
| Stage | Bimekizumab 64 mg Q4W | Bimekizumab 160 mg Q4W | Bimekizumab 320 mg Q4W |
|---|---|---|---|
| STARTED | 15 | 111 | 91 |
| COMPLETED | 15 | 92 | 75 |
| NOT COMPLETED | 0 | 19 | 16 |
Reasons for not completing this period:
| Reason | Bimekizumab 64 mg Q4W | Bimekizumab 160 mg Q4W | Bimekizumab 320 mg Q4W |
|---|---|---|---|
| Death | 0 | 0 | 1 |
| Adverse Event | 0 | 4 | 2 |
| Protocol Violation | 0 | 1 | 0 |
| Lost to Follow-up | 0 | 2 | 1 |
| Withdrawal by Subject | 0 | 3 | 4 |
| WITHDRAWAL CRITERIA #9 | 0 | 4 | 6 |
| WITHDRAWAL CRITERIA #12 | 0 | 4 | 2 |
| PDILI and WITHDRAWAL CRITERIA #9 | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication in PS0011.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Baseline characteristics refer to the Safety Set (SS) which consisted of all participants who received at least 1 dose of the investigational medicinal product (IMP) in PS0011.
| Characteristic | Unit | Bimekizumab 64 mg Q4W | Bimekizumab 160 mg Q4W | Bimekizumab 320 mg Q4W | Total Title |
|---|---|---|---|---|---|
| Participants analysed | 15 | 111 | 91 | 217 | |
| Age, Categorical: <=18 years | Participants | 0 | 1 | 2 | 3 |
| Age, Categorical: Between 18 and 65 years | Participants | 14 | 105 | 77 | 196 |
| Age, Categorical: >=65 years | Participants | 1 | 5 | 12 | 18 |
| Age, Continuous | years | 44.5 (SD 14.7) | 44.5 (SD 12.8) | 43.5 (SD 14.7) | 44.1 (SD 13.7) |
| Sex: Female, Male: Female | Participants | 6 | 40 | 31 | 77 |
| Sex: Female, Male: Male | Participants | 9 | 71 | 60 | 140 |
| Race/Ethnicity, Customized: American Indian /Alaskan native | Participants | 0 | 1 | 1 | 2 |
| Race/Ethnicity, Customized: Asian | Participants | 1 | 11 | 6 | 18 |
| Race/Ethnicity, Customized: Black | Participants | 1 | 0 | 1 | 2 |
| Race/Ethnicity, Customized: White | Participants | 13 | 99 | 83 | 195 |
6. Primary Endpoint
The registry lists the primary outcome as Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment, measured over From Baseline until Safety Follow-Up Visit (up to Week 64).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | no. of new events per 100 subject-years |
| Endpoint classification | Event-Rate Endpoint |
The primary endpoint is the incidence of treatment-emergent adverse events adjusted for the duration of participant exposure to treatment. The stated unit is the number of new events per 100 subject-years. The registry defines treatment-emergent events as events that began on or after the first dose of PS0011 study medication, or events whose severity worsened on or after that dose. This definition sets the period during which an event qualifies for the endpoint.
Exposure adjustment is used when participants contribute different amounts of time at risk. A rate based on subject-time relates event occurrence to the time participants were observed and at risk, rather than treating every participant as if they had the same follow-up. In general, this can make rates more informative than raw counts when observation time varies. It does not, by itself, make groups comparable or remove differences in their characteristics.
The registry describes an exposure-adjusted incidence rate based on the number of participants with a specific adverse event and their time at risk, scaled to 100 subject-years. It also specifies a 95% confidence interval as the measure of dispersion. However, the numerical rate and interval for the primary endpoint are not reported in the registry record. The endpoint definition therefore explains what was intended to be measured, but the posted information does not show the estimated rate or how precisely it was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical feature of this study is the combination of a time-adjusted safety endpoint and a non-randomized extension design. The primary endpoint was intended to account for duration of exposure when describing treatment-emergent adverse events. That is relevant because participants may contribute different periods of observation. Yet an exposure-adjusted rate is still descriptive of the observed groups; it does not make group assignment random or establish that any difference between groups was caused by treatment.
The treatment groups reflect the preceding study and, for some participants, their Week 12 PASI90 response. Bimekizumab regimens could continue or be increased, while the described placebo group included participants with a PASI90 response who had received placebo in PS0010. This means the groups may differ in prior treatment, response, and other characteristics. The registry record does not report adjustments for those differences, so an adjusted comparative interpretation cannot be assessed.
The registry describes the primary endpoint and its intended confidence interval but does not report a numerical rate or confidence interval. Consequently, the posted results available in this record do not establish the magnitude of the primary endpoint or its statistical precision. The presence of a confidence-interval specification is not itself a result. Without the estimate and interval, readers cannot assess the range of values compatible with the analysis.
The adverse-event summary lists counts of participants at risk and participants affected for three bimekizumab dose groups, along with deaths. These counts can describe what was recorded in those groups, but they are not the exposure-adjusted primary endpoint rate. The record does not report exposure time for those summaries, and the counts alone cannot be converted into subject-year rates without additional information. The listed serious-event terms and percentages likewise do not supply a full comparative analysis.
Secondary outcomes include PASI90 response over time and investigator global assessment response over time. The registry record lists these outcomes but does not provide numerical results for them. The number of analyses is recorded as zero, which does not explain whether analyses were performed or how outcomes were handled; the analysis details are not reported in the registry record. Overall, this record supports understanding the study’s intended safety measure and design, but not a conclusion about comparative efficacy or the magnitude of safety risks.
9. Statistical Methods Explained
The primary outcome is an exposure-adjusted incidence rate, a type of rate that relates event occurrence to time at risk. The registry states that the rate was scaled to 100 subject-years. In general, subject-years represent the sum of participants’ time under observation, expressed in years. A rate based on that accumulated time can account for differing follow-up durations more directly than a simple count. It is not the same as the proportion of participants who experienced an event, and it should not be read as an individual participant’s probability.
What does exposure adjustment mean?
Participants can have unequal opportunities for an event to be observed if their follow-up differs. An unadjusted count does not reflect how long each person was observed. An exposure-adjusted rate uses time at risk in its denominator, so the amount of observation contributes to the rate. The registry’s description defines the numerator around participants experiencing a specific adverse event and describes the denominator as the total time at risk, scaled to 100 subject-years. It specifies that participants with an event contribute time until their first occurrence, while those without the event contribute their time at risk.
In general, time-adjusted rates are useful for summarizing event occurrence when exposure time varies. They do not remove all limitations. A rate can be affected by how event onset is defined, how follow-up ends, and whether participants with different characteristics contribute different amounts of time. Exposure adjustment does not itself control confounding, account for non-random treatment assignment, or show that an observed difference is caused by treatment.
What does the confidence interval add?
The registry specifies a 95% confidence interval for the primary rate. In general, a confidence interval expresses statistical uncertainty around an estimate under the analysis assumptions. A narrower interval indicates greater precision than a wider interval, while the interval’s location describes the range of values compatible with the data and method. It does not capture every source of uncertainty, including possible bias from the study design or incomplete reporting.
The registry record does not report the primary rate or its confidence interval. Therefore, neither the estimated event rate nor its precision can be assessed from the recorded endpoint information. The adverse-event counts elsewhere in the record cannot stand in for the missing rate and interval, because the primary endpoint is exposure-adjusted and the counts do not include the required time-at-risk information.
Why does the allocation matter?
Random allocation, in general, is intended to make treatment groups comparable on average at the point of assignment. This study’s extension allocation is listed as non-randomized. The descriptions also show that some treatment decisions depended on prior regimen and Week 12 response in PS0010. As a result, the groups have a treatment history that is relevant to interpretation. The placebo group is not a like-for-like randomized control group for the extension’s bimekizumab groups.
Masking and allocation address different potential sources of bias. Masking can reduce the influence of knowledge of treatment on participant or investigator behavior and on outcome assessment. The registry lists quadruple masking, but does not identify which roles were masked. Masking does not create randomization, balance baseline characteristics, or eliminate other sources of bias.
How should the safety counts be distinguished from rates?
The safety summary reports participants at risk and affected for the three listed bimekizumab dose groups. Such counts describe the recorded number of affected participants in those groups. A count does not indicate how long participants were observed, and it does not provide the rate per 100 subject-years. In general, interpreting counts as rates requires exposure-time information and a clearly defined event measure. No such numerical exposure-adjusted endpoint estimates are reported in the registry record.
Likewise, a percentage attached to a serious-event term is a descriptive figure whose denominator and calculation details need to be understood before it is compared with another percentage. The record lists the term and percentage but does not report a comparative model or the detailed analysis population for each term. These entries should not be treated as evidence of a statistically tested difference between treatment groups.
What cannot be inferred about the analysis?
The registry record does not report the statistical model used for the primary endpoint, any adjustment variables, the handling of recurrent events, or the method used to construct the confidence interval. It also does not report a sample-size justification, interim analyses, or a statistical analysis plan. General methods for event-rate analysis can help explain the endpoint’s purpose, but they should not be mistaken for methods confirmed to have been used in this study.
The record lists zero analyses. That entry does not establish that no analyses were conducted; the analyses themselves and their status are not reported in the registry record. Nor can an unreported estimate be reconstructed from the group counts alone. A complete interpretation would require the numerical endpoint results and the relevant analytic details, particularly exposure time and the method used to account for the non-randomized group structure.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures, including the primary adverse-event endpoint and secondary response outcomes over time. It does not report how multiplicity across outcomes or repeated assessments was handled. In general, testing multiple outcomes or time points can increase the chance of at least one apparently notable result, so a prespecified testing strategy can matter. The registry record does not describe such a strategy, and no multiplicity adjustment should be assumed.
Missing-data methods are not reported in the registry record. The information available does not say how missing outcome assessments, withdrawals, incomplete follow-up, or missing adverse-event information were handled. The record also does not give participant flow or explain whether outcome analyses used all eligible participants or subsets. The safety population is defined as participants who received at least 1 dose of PS0011 study medication; the detailed analysis populations for the secondary outcomes are not reported.
The registry lists zero analyses, but this does not establish that analyses were not performed. The statistical analysis plan, model specifications, and handling of missing data are not reported in the registry record. Accordingly, the listed endpoints and populations describe intended or defined measures, not a complete account of how the posted results were analyzed.
These omissions limit assessment of precision and robustness. In particular, the primary endpoint’s numerical estimate and confidence interval are not reported, and the record does not describe whether incomplete exposure or follow-up affected the rate calculation. Conclusions about analysis choices or sensitivity to missingness cannot be drawn from the available registry information.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Bimekizumab 64 mg Q4W (SS) | 1 | 15 | 6.7% |
| Bimekizumab 160 mg Q4W (SS) | 7 | 111 | 6.3% |
| Bimekizumab 320 mg Q4W (SS) | 7 | 91 | 7.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Bimekizumab 64 mg Q4W (SS) | 0 of 15 |
| Bimekizumab 160 mg Q4W (SS) | 0 of 111 |
| Bimekizumab 320 mg Q4W (SS) | 2 of 91 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Bimekizumab 64 mg Q4W (SS) | 10 of 15 |
| Bimekizumab 160 mg Q4W (SS) | 56 of 111 |
| Bimekizumab 320 mg Q4W (SS) | 51 of 91 |
Most frequent serious adverse event terms
| Event term | Organ system | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 320 mg Q4W (SS) |
|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | 0 of 15 | 1 of 111 | 0 of 91 |
| Cataract | Eye disorders | 0 of 15 | 0 of 111 | 1 of 91 |
| Non-cardiac chest pain | General disorders | 1 of 15 | 0 of 111 | 0 of 91 |
| Otitis externa bacterial | Infections and infestations | 0 of 15 | 0 of 111 | 1 of 91 |
| Staphylococcal abscess | Infections and infestations | 0 of 15 | 1 of 111 | 0 of 91 |
| Humerus fracture | Injury, poisoning and procedural complications | 0 of 15 | 0 of 111 | 1 of 91 |
| Tibia fracture | Injury, poisoning and procedural complications | 0 of 15 | 0 of 111 | 1 of 91 |
| Hepatic enzyme increased | Investigations | 0 of 15 | 1 of 111 | 0 of 91 |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 15 | 1 of 111 | 0 of 91 |
| Carpal tunnel syndrome | Nervous system disorders | 0 of 15 | 0 of 111 | 1 of 91 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bimekizumab 64 mg Q4W (SS) | Bimekizumab 160 mg Q4W (SS) | Bimekizumab 320 mg Q4W (SS) |
|---|---|---|---|---|
| Oral candidiasis | Infections and infestations | 1 of 15 | 13 of 111 | 15 of 91 |
| Nasopharyngitis | Infections and infestations | 2 of 15 | 15 of 111 | 11 of 91 |
| Upper respiratory tract infection | Infections and infestations | 1 of 15 | 10 of 111 | 9 of 91 |
| Hypertension | Vascular disorders | 2 of 15 | 8 of 111 | 4 of 91 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 0 of 15 | 6 of 111 | 6 of 91 |
| Psoriasis | Skin and subcutaneous tissue disorders | 2 of 15 | 5 of 111 | 5 of 91 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 0 of 15 | 3 of 111 | 6 of 91 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | 1 of 15 | 5 of 111 | 3 of 91 |
| Gamma-glutamyl-transferase increased | Investigations | 1 of 15 | 4 of 111 | 3 of 91 |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | 1 of 15 | 3 of 111 | 2 of 91 |
Serious events with the highest arm-level rate: non-cardiac chest pain (6.7%), cataract (1.1%), otitis externa bacterial (1.1%), humerus fracture (1.1%), tibia fracture (1.1%).
The safety summary gives, for each listed bimekizumab dose group, the number of participants at risk and the number affected by serious or other adverse events, as well as deaths. For serious events, the entries are 1 affected among 15 at risk in the 64 mg Q4W group, 7 among 111 in the 160 mg Q4W group, and 7 among 91 in the 320 mg Q4W group. Deaths are recorded as 0, 0, and 2 for those groups, respectively. These are descriptive group counts, not exposure-adjusted rates or comparative effect estimates.
The registry also lists serious-event terms, including non-cardiac chest pain at 6.7%, and cataract, bacterial otitis externa, humerus fracture, tibia fracture, and carpal tunnel syndrome at 1.1% each. The record does not provide detailed denominators or a comparative statistical analysis for these terms. The percentages should therefore be read as recorded descriptive figures, not as evidence of differences between dose groups.
Because follow-up time is not reported alongside these counts, the figures do not show the event rate per 100 subject-years specified for the primary endpoint. The non-randomized extension design also means the dose groups are not like-for-like randomized comparison groups. These summaries describe recorded safety events; they do not establish that a regimen caused or prevented an event.
12. What the Result Does, and Does Not, Mean
The record documents a completed Phase 2 extension study of bimekizumab in adults with moderate to severe chronic plaque psoriasis. It specifies a primary safety endpoint based on treatment-emergent adverse events adjusted for duration of exposure, with a stated unit of events per 100 subject-years and a planned confidence-interval measure. It also records serious and other adverse-event counts for three bimekizumab dose groups and lists secondary response outcomes.
Those details establish what the study was designed to assess and provide some descriptive safety information. They do not establish the numerical value or precision of the primary endpoint: its rate and confidence interval are not reported in the registry record. The listed participant counts and event counts cannot substitute for that time-adjusted estimate. Secondary outcome names are recorded, but numerical results are not reported in the registry record.
The extension’s non-randomized allocation is central to what can be concluded from group comparisons. Treatment paths were linked to prior treatment and, for some participants, Week 12 response. Thus, any apparent contrast between the placebo and bimekizumab groups would not be a like-for-like randomized comparison. The registry record does not report an analysis that adjusts for those differences, and it does not provide the statistical plan needed to evaluate such an analysis.
In general, a study can describe adverse events observed during treatment without proving that treatment caused them. Equally, a lack of a reported numerical estimate is not evidence that an event did not occur or that groups were the same. The record supports a careful description of the design, endpoint definition, and recorded safety counts, but it does not support a quantitative conclusion about comparative safety or efficacy.
13. Why This Trial Matters Statistically
This trial illustrates why endpoint definitions and study design need to be read together. Its primary endpoint adjusts adverse-event incidence for time at risk, which is a useful distinction when participants can contribute different follow-up durations. A raw count and an exposure-adjusted rate answer different descriptive questions. The registry specifies the rate’s intended unit and provides a definition, but does not report the numerical estimate or confidence interval needed to judge its magnitude and precision.
The extension structure also shows why an apparent treatment contrast may not have a straightforward causal interpretation. Treatment assignment was non-randomized in PS0011, and the regimen descriptions depend partly on earlier treatment and Week 12 response. The listed placebo group therefore does not function as a like-for-like randomized comparator. Masking may affect some sources of bias, but it does not replace random allocation or resolve differences arising from treatment history.
Finally, the record demonstrates the difference between a study’s stated outcomes and its reported results. The primary safety measure and secondary response outcomes are defined, and safety counts are listed, but the numerical primary rate, confidence interval, and secondary outcome results are not reported in the registry record. Statistical interpretation depends not only on an endpoint’s name or definition, but also on transparent estimates, uncertainty measures, analysis details, and an understanding of how groups were formed.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation is incomplete reporting of the main endpoint. Although the registry defines an exposure-adjusted adverse-event rate and specifies a 95% confidence interval, neither the numerical rate nor its interval is reported in the registry record. The event counts do not include the exposure time needed to assess that rate. The listed secondary outcomes also lack numerical results in this record.
Group comparisons are limited by the non-randomized allocation in the extension. The treatment descriptions depend on previous treatment and, for some groups, Week 12 PASI90 response. The placebo group is drawn from participants with a particular prior treatment and response history, so it is not a like-for-like randomized comparator. The registry record does not report adjustment methods that might address these differences.
Further details needed to evaluate the estimates are not reported in the registry record. These include participant flow, exposure duration by group, the statistical model and confidence-interval method, missing-data handling, and the approach to repeated events. The record also does not report the statistical analysis plan, sample-size justification, or interim analyses. The listed counts and serious-event percentages therefore provide only a limited descriptive view and cannot establish comparative effects or explain the precision of the primary endpoint.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis — NCT03010527.
- Registry record last updated 2022-10-18; status last verified 2022-09.
- Results first posted 2021-10-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
This completed Phase 2 extension study assessed long-term safety, tolerability, and efficacy of bimekizumab in adults with moderate to severe chronic plaque psoriasis. The registry lists a parallel-group, placebo-controlled design with quadruple masking and non-randomized allocation. Treatment paths in the extension were linked in part to prior regimen and Week 12 PASI90 response.
The primary endpoint was treatment-emergent adverse events adjusted for duration of exposure, expressed per 100 subject-years, with a 95% confidence interval specified. Its numerical rate and interval are not reported in the registry record. Serious and other adverse-event counts and deaths are listed for three bimekizumab dose groups, but these counts are not exposure-adjusted rates. Secondary response outcomes are named, while their numerical results and detailed analysis methods are not reported in the registry record.