MIcrovascular dysfuNction In Moderate-severe Psoriasis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for MIcrovascular dysfuNction In Moderate-severe Psoriasis (NCT04271540), a na phase 4 study. The primary outcome is Change in Global Coronary Flow Reserve (CFR) After 6 Months of Therapy With Tildrakizumab.

2. Clinical Question

The study asks whether coronary flow reserve (CFR), measured with cardiac positron emission tomography (PET), changes from baseline after tildrakizumab therapy in people with moderate-severe psoriasis. The registry record frames the question around cardiovascular risk associated with psoriasis and whether reducing inflammation might affect coronary vascular function. That rationale is not itself evidence that the treatment changes CFR or cardiovascular outcomes.

3. Trial Design

This is a completed phase 4 study with a single-group model and allocation listed as not applicable. Tildrakizumab is the intervention. The registry record lists enrollment as 36 and describes the study population in its title as people with moderate-severe psoriasis. Detailed eligibility criteria and participant characteristics are not reported in the registry record.

The study description outlines a baseline rest/stress cardiac PET scan and a final PET scan at 6 months after the intervention. The primary endpoint is described as change in global CFR from baseline, measured at 24 weeks. The difference between these time descriptions is not explained in the registry record. It also does not report the exact timing of individual scans or the treatment schedule.

Masking is listed as none. With one group and no comparator, the main question is framed as within-group change over time, rather than a contrast between groups. A within-group change can describe how a measure differs between two assessments, but by itself it does not isolate the intervention’s effect from other explanations, such as changes over time or measurement variation.

The record lists three secondary outcomes: correlation between change in global CFR and psoriasis skin severity, change in peak-stress global myocardial blood flow, and change in peak-stress global coronary vascular resistance. It lists four outcome measures and one analysis. Further details of the statistical analysis plan, including any covariate adjustment or handling of repeated measurements, are not reported in the registry record.

The study is marked completed, with start listed as 2020-04-04 and primary completion listed as 2024-07-03. A rationale for the enrollment target, a formal sample-size justification, and details of any interim analyses are not reported in the registry record.

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.

Overall Study

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Change in Global Coronary Flow Reserve (CFR) After 6 Months of Therapy With Tildrakizumab, measured over 24 weeks.

The primary endpoint is change in global coronary flow reserve (CFR) after 6 months of tildrakizumab therapy, with the timeframe listed as 24 weeks. CFR is a ratio of peak vasodilator-stress myocardial blood flow to resting myocardial blood flow. The registry record describes both measurements as derived from cardiac PET imaging.

As a general statistical and physiological concept, a reserve measure expresses the capacity to increase flow under stress relative to flow at rest. It is used in this study as an indicator of coronary vascular function and myocardial perfusion. The registry description says impaired myocardial blood flow reserve is defined by a ratio below 2.0 and associates that definition with increased cardiovascular risk. That contextual threshold does not substitute for reporting the study’s actual endpoint result.

The endpoint is specified as a mean of a continuous measure, with standard deviation as the dispersion measure. In general, a mean describes the average observed value or change, while a standard deviation describes variability among observations. The registry record does not report the baseline or follow-up mean CFR, the mean change, its standard deviation, or a confidence interval. Consequently, the magnitude and precision of the primary endpoint cannot be assessed from the posted results described in the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a continuous measure: change in global CFR. The record identifies the summary parameter as a mean and the dispersion measure as standard deviation. These choices describe how a set of numerical changes may be summarized, but they do not reveal the result unless the estimate and its uncertainty are reported. The primary outcome estimate is not reported in the registry record.

What does a mean change describe?

In general, a mean change is the average of participant-level differences between follow-up and baseline measurements, under a specified calculation approach. It provides a measure of the central tendency of those changes. A mean can be informative, but it may conceal variation: participants can have changes in different directions or of different magnitudes while contributing to the same average. The registry record does not report individual data, the mean change, or details of how incomplete pairs of measurements were handled.

A standard deviation describes the spread of observations around a mean. It is not the same as the standard error, which describes the sampling uncertainty of an estimate. A confidence interval is a general way to express uncertainty around an estimate; its width reflects both the variability in the data and the amount of information available under the analysis. The registry record does not report a confidence interval for the primary change. Without an estimate and its uncertainty, neither the size nor the precision of the primary result can be evaluated.

What does the single-group design imply?

For a single-group before-and-after measure, the descriptive quantity of interest is change within the group. As a general statistical concept, a within-person comparison can account for stable characteristics of each person when assessing change, if the analysis uses paired measurements. However, it does not by itself control for influences that change over time. A control group can help estimate what might have happened without the intervention, but the registry record does not identify one for this study. The record also does not specify whether the primary analysis used a paired method or another approach.

The absence of masking is listed in the design. In general, masking can reduce some forms of influence on care, assessment, or reporting, depending on who is masked and how outcomes are measured. The registry record lists masking as none, but does not describe assessor procedures or other safeguards. PET-derived measurements are quantitative, yet their acquisition and processing can still depend on study procedures; further quality-control details are not reported in the registry record.

How should planning illustrations be read?

Sample-size illustrations are planning calculations, not observed power. The stated assumptions describe two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. The illustrations are not a description of the actual single-group design, which has no two-arm allocation. Their assumptions should therefore be distinguished from the trial’s design and from any analysis of its observed data. The registry record does not report the trial’s own sample-size justification or design assumptions.

In general, a planning calculation estimates the amount of information needed for a future study under chosen assumptions. It does not show that a completed study had a particular probability of detecting its result, and it is not a substitute for a confidence interval or an outcome estimate. The observed primary effect used as the basis for the stated illustrations is not numerically reported in the registry record. No illustration value is described.

What can be inferred from the listed analyses?

The registry record lists one analysis and four outcome measures. It names one primary outcome and three secondary outcomes. The record does not report the statistical test or model used, a prespecified analysis population, covariates, treatment of outliers, or a method for calculating uncertainty. A test result alone, even if reported, would not convey the size or practical importance of an effect; estimates and uncertainty are also needed for interpretation.

For the secondary outcome concerning correlation between change in global CFR and psoriasis skin severity, a correlation would describe the degree to which the two measured changes vary together under a specified method. It would not by itself show that one change causes the other. The methods and numerical result for that correlation are not reported in the registry record. Numerical results for the other secondary outcomes are also not reported in the registry record.

These general principles help distinguish a measurement plan from an analysis result. The registry record specifies the primary measure, its unit as a CFR ratio, and a mean with standard deviation as the intended summary. It does not provide the numerical estimate or enough methodological detail to reconstruct an analysis. Thus, no recalculated result or assessment of the primary estimate’s precision can be made from the registry information.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Subjects treated with Tildrakizumab")
n   <- c(30)
m   <- c(-0.03)
sp  <- c(0.83)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Subjects treated with Tildrakizumab  30  -0.030  0.830  -0.340  0.280

11. Multiplicity, Missing Data and Analysis Populations

The registry record identifies one primary outcome and three secondary outcomes, and lists four outcome measures. When several outcomes are examined, multiplicity is a general statistical concern: the chance of at least one apparently notable result can increase when many statistical tests are conducted. Studies may address this through a prespecified hierarchy, adjustment, or by treating secondary findings as exploratory. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or the statistical tests used. The number of listed analyses alone does not establish how testing was handled.

Missing data can also affect interpretation of a change-from-baseline endpoint. In general, a participant without both a baseline and follow-up measurement may not contribute to a paired change estimate, depending on the chosen analysis. Different approaches to incomplete observations rely on different assumptions and can yield different estimates. The registry record does not report the amount or pattern of missing endpoint data, reasons for missingness, imputation, or sensitivity analyses.

The analysis population is not reported in the registry record. It is therefore unclear which participants, among those enrolled, were included in the primary endpoint analysis or what rules governed inclusion. The enrollment entry lists 36, while the safety group’s at-risk denominators are 31; the record does not explain that difference. These entries should be read in their respective contexts rather than treated as a common analysis denominator.

Further details about protocol deviations, exclusions, and handling of incomplete scans are not reported in the registry record. Without these details and the primary outcome estimate, the completeness and robustness of the primary analysis cannot be assessed.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry record lists one group, Subjects treated with Tildrakizumab. For serious adverse events, 31 participants are listed as at risk and 0 as affected; deaths are listed as 0. For the registry’s other adverse-event category, 31 participants are listed as at risk and 3 as affected. These are recorded counts, not estimates of comparative risk, because the study has no like-for-like control group.

The at-risk denominator is the group size associated with each safety entry in the registry. It is not the same entry as the overall enrollment of 36, and the record does not explain why the safety denominator differs. No total or percentage should be inferred from these entries. The registry record also lists no top serious-event terms; this does not supply additional detail about the nature of events outside the counts.

In general, safety counts depend on the event definitions, observation period, and completeness of reporting. Those details are not reported in the registry record. The figures therefore describe the recorded safety entries for this group, but do not establish comparative safety or explain the cause of any event.

13. What the Result Does, and Does Not, Mean

The study addresses a question about a measurable aspect of coronary vascular function: whether global CFR changes from baseline after tildrakizumab therapy in people with moderate-severe psoriasis. The registry record describes PET measurement at baseline and follow-up and identifies change in global CFR as the primary endpoint. Its rationale links psoriasis-related inflammation with cardiovascular risk and proposes measuring coronary function. This is a study rationale, not a reported finding.

The key limit is that the registry record does not report the primary endpoint result. It therefore does not show the direction or size of any change, nor how precisely a change was estimated. The outcome’s definition and the study’s completed status cannot be used to fill in that missing result. A result not reported in the registry record is not the same as a result of no change.

Even if a within-group change were reported, a single-group design would support a descriptive account of change over time, not a controlled comparison against no treatment or another treatment. As a general principle, causal interpretation requires considering what would have happened to the same population over that period in the absence of the intervention. This study’s registry record does not identify a comparison group.

The endpoint is a physiological measure, not a direct report of cardiovascular events, symptoms, or prognosis. The registry record’s rationale mentions possible downstream relevance, but the primary endpoint alone cannot establish those outcomes. The record lists secondary measures related to myocardial blood flow, vascular resistance, and psoriasis severity; their numerical results are not reported in the registry record.

Thus, the record supports describing the question and design, but it does not support a conclusion about whether CFR changed or whether any change was attributable to tildrakizumab. The safety entries are likewise descriptive counts from a single group and do not provide a controlled comparison.

14. Why This Trial Matters Statistically

This study is statistically interesting because it links an inflammatory disease context to a quantitative measure of coronary function. CFR is defined in the registry record through the relationship between stress and resting myocardial blood flow, and PET is the stated measurement approach. This makes the primary question more specific than a broad question about cardiovascular risk: it concerns change in a particular physiological measure over time.

The design also illustrates the distinction between measuring change and estimating an intervention effect. A baseline and follow-up measure can characterize within-group change, while a control group would help interpret how much of that change is attributable to the intervention rather than time or other influences. This trial is listed as single-group, with no like-for-like control. The limitation is especially relevant when interpreting a result, though the primary result itself is not reported in the registry record.

Another statistical issue is the connection between the planned endpoint and the result needed for interpretation. A mean and standard deviation are identified as the summary approach, but the registry record does not report the estimate or its precision. Readers therefore cannot assess whether any observed change was small or large, or whether the data were precise or uncertain. A complete account of results needs more than an endpoint definition and study status.

The record also lists related secondary outcomes, including measures of myocardial blood flow and coronary vascular resistance. These may provide complementary descriptions of coronary function, while the listed correlation outcome addresses whether changes in CFR and psoriasis skin severity vary together. Without methods and numerical results, these outcomes cannot be evaluated or used to corroborate the primary finding.

Finally, the enrollment and safety entries illustrate why denominators should be tied to the specific outcome being read. The record lists enrollment as 36 and a safety at-risk group of 31, without explaining the difference. Keeping those entries distinct avoids implying that every participant contributed to every analysis.

15. 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 principal limitation for interpreting this registry record is that it does not report the primary outcome estimate. The record names change in global CFR as the primary endpoint, but gives no baseline or follow-up mean, mean change, standard deviation, confidence interval, or p-value. The primary result’s direction, magnitude, and precision are therefore unavailable in the registry record.

The single-group design provides no like-for-like control comparison. Any within-group change, if reported, would not by itself separate an intervention-related change from time-related or measurement-related variation. Masking is listed as none. The registry record does not describe additional procedures intended to reduce assessment or measurement bias.

The record’s timing descriptions are not identical: the primary endpoint timeframe is 24 weeks, while the study description says the final PET scan would occur at 6 months after the intervention. The record does not explain this wording or provide individual measurement dates. It also does not report detailed eligibility criteria, participant characteristics, treatment schedule, or analysis methods.

The analysis population and missing-data approach are not reported in the registry record. Nor are there details on outcome definitions beyond the primary endpoint description, multiplicity handling, or sensitivity analyses. These omissions limit assessment of how results would be analyzed and how robust they might be.

For safety, enrollment is listed as 36 while the group at risk is listed as 31 for both serious and other adverse-event reporting. The record does not explain the different denominators. Safety counts are also from a single group, so they do not support a comparative safety estimate. These limitations are specific to the information recorded and do not establish what methods or results may exist outside the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: MIcrovascular dysfuNction In Moderate-severe Psoriasis — NCT04271540.
• Registry record last updated 2025-11-25; status last verified 2025-11.
• Results first posted 2025-11-25.
• 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.

19. Record Summary

The registry record describes NCT04271540, a completed phase 4, single-group study of tildrakizumab in moderate-severe psoriasis. Enrollment is listed as 36, allocation as not applicable, and masking as none. The study’s primary endpoint is change in global CFR, measured by PET, with a timeframe of 24 weeks. The record defines CFR as the ratio of peak vasodilator-stress to resting myocardial blood flow and specifies a mean with standard deviation as the summary approach.

Three secondary outcomes are listed: correlation between change in global CFR and psoriasis skin severity, change in peak-stress global myocardial blood flow, and change in peak-stress global coronary vascular resistance. The registry record does not report the numerical primary or secondary outcome results, the analysis population, missing-data methods, or a detailed statistical analysis plan.

The safety group lists 31 participants at risk, 0 affected by serious adverse events, 3 affected in the other adverse-event category, and 0 deaths. The record does not explain the safety denominator relative to enrollment.