Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis (NCT00936065), a randomized phase 4 study. The primary outcome is Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24.

2. Clinical Question

The study was a phase 4 pilot trial in Korean patients with moderate to severe psoriasis. Its primary question is descriptive as well as comparative: the observed percentages indicate how often the threshold was reached in each group, while the intervals show how uncertain those percentages are in the analyzed participants. The registry record does not report a formal hypothesis specifying which pairwise comparison was primary, nor does it report a planned sample-size justification. Therefore, the results should be read as findings from this trial rather than as a definitive ranking of the regimens.

3. Trial Design

This was a randomized, open-label, parallel-group, multicenter phase 4 trial. The registry lists an enrollment of 60 and marks the study completed. The recorded start was 2009-07, and primary completion was 2011-04. Masking was listed as none, meaning the study was open rather than blinded according to the registry record.

Three groups appear in the posted primary results: etanercept, etanercept and acitretin, and acitretin. The official title describes an etanercept schedule involving 50 mg twice weekly followed by 25 mg twice weekly, a combination of etanercept 25 mg twice weekly and acitretin, and acitretin alone. The brief summary specifies acitretin 10 mg BID in the combination. However, the registry’s descriptions for Group A, Group B, and Group C are blank. The record therefore does not establish the detailed regimen assigned to each group label beyond the overall intervention descriptions.

The primary endpoint was assessed at week 24. The primary analysis population was modified intent to treat: randomized participants who took at least one dose of test article and had both a baseline and an on-therapy PASI evaluation. The registry specifies Last Observation Carried Forward for this endpoint. The denominators in the posted primary results are 21 for etanercept, 19 for etanercept and acitretin, and 18 for acitretin. These are the analyzed group sizes for the posted outcome, not the enrollment count.

Other recorded outcomes include PASI 50, several Physician Global Assessment categories, and time-to-achievement outcomes. The record lists 33 outcome measures and 174 analyses. It does not report the randomization procedure, allocation concealment, intended allocation ratio, or a detailed statistical analysis plan. The trial’s original sample-size assumptions 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:

Analysis population for the primary outcome, as defined in the registry: Modified intent to treat (mITT) population: randomized participants who took at least 1 dose of test article and had both baseline and on-therapy PASI evaluations; Last Observation Carried Forward (LOCF)

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 Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24, measured over Week 24.

The primary endpoint is the percentage of participants achieving a 75% improvement in PASI at week 24. PASI combines the extent of skin involvement with clinical assessments of erythema, induration, and desquamation across body regions. Its score ranges from 0, indicating no disease, to 72, indicating maximal disease. For each body region, the area involved and the severity of the clinical signs contribute to the overall score.

PASI 75 is a responder threshold: a participant is counted as achieving the endpoint if their PASI improvement reaches the stated 75% level. The reported group percentage therefore describes the proportion meeting a defined response criterion, rather than the size of the average score change. This kind of endpoint can make results easier to interpret in terms of how many participants crossed a clinically specified improvement threshold, while still discarding information about the degree of improvement among participants who do not cross it.

The endpoint is assessed at week 24, and the primary population requires both baseline and on-therapy PASI evaluations, as well as at least one dose of test article. The registry specifies LOCF for the primary endpoint, which uses the last observed value carried forward for participants with missing later measurements. The registry record does not report the amount or pattern of missing PASI data, or further details of how the endpoint’s percentage improvement was implemented in the analysis.

7. Results Posted in the Registry

• Etanercept and Acitretin: 57.9% (11/19) versus 52.4% (11/21) on control; risk difference 5.5 percentage points (95% CI -25.3 to 36.3), risk ratio 1.11 (0.63–1.93); unadjusted two-proportion z-test p = 0.726.
• Acitretin: 22.2% (4/18) versus 52.4% (11/21) on control; risk difference -30.2 percentage points (95% CI -58.9 to -1.4), risk ratio 0.42 (0.16–1.10); unadjusted two-proportion z-test p = 0.054.

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is binary at the participant level: each participant either achieved PASI 75 by week 24 or did not. A group percentage is the number of participants meeting the threshold relative to the analyzed group denominator, expressed as a percentage. This describes the observed frequency of the endpoint in that group. It does not indicate the average PASI score, and it does not capture how far below or above the threshold each participant’s result fell.

What does a confidence interval describe?

A confidence interval describes uncertainty in an estimated quantity under the statistical method used. For a group percentage, it gives a range of values that are more or less compatible with the observed data and method. Wider intervals indicate less precision. The reported group intervals are broad, consistent with the relatively small analyzed groups. They should be read as uncertainty around each group’s percentage, not as a range containing a fixed proportion of individual participant outcomes.

For a comparison, the risk difference is the difference between the two group response proportions, expressed on the proportion scale. A value of zero represents equal observed proportions in the comparison. A confidence interval extending across zero includes values corresponding to differences in either direction. The recalculated interval for etanercept and acitretin compared with etanercept alone extends from -0.253 to 0.363. The recalculated interval for acitretin compared with etanercept extends from -0.589 to -0.014. These intervals belong to the recalculated, unadjusted pairwise comparisons, not to the sponsor-reported overall test.

What does the p-value answer?

A p-value describes how incompatible the observed data are with a specified null model, assuming that model and the test’s assumptions apply. It is not the probability that the null hypothesis is true, nor does it measure the size or practical importance of a difference. The sponsor reported a Fisher exact test across the three groups, with p = 0.067. The recalculated pairwise comparisons have unadjusted p-values of 0.726 and 0.054. These values come from different analyses and should not be treated as interchangeable. The record does not report an adjustment for multiple comparisons, so the pairwise p-values are described as unadjusted.

Fisher’s exact test is a method for comparing categorical outcomes in groups, using the observed counts and group sizes. It is often useful when group sizes or event counts are limited because it evaluates the distribution of counts without relying on the usual large-sample approximation used by some other tests. The sponsor’s reported test is an overall three-group analysis. It does not, on its own, identify which particular pair of groups accounts for any differences in the observed counts.

Why can over-dispersion matter?

For binary outcomes, a simple binomial model assumes that each participant’s outcome follows the same event probability within a group and that participant outcomes are independent, conditional on the model. Over-dispersion means the observed variation is greater than that model expects. General statistical practice treats over-dispersion as a concern because standard errors may be too small if extra variability is ignored, making intervals too narrow and tests too optimistic. The registry record does not report a model-based analysis of over-dispersion, and the posted primary analysis is a percentage endpoint with a reported Fisher exact test.

How should the analysis population be understood?

The primary population is modified intent to treat, defined in the registry as randomized participants who took at least one dose of test article and had both baseline and on-therapy PASI evaluations. This is not necessarily identical to every randomized participant. The group denominators in the primary results are 21, 19, and 18. The registry specifies Last Observation Carried Forward, or LOCF, for the endpoint. LOCF carries the last observed value forward when a later value is unavailable. It creates an analysis value but does not recover the unobserved measurement. Its implications depend on why the later data are missing and how participants’ outcomes would otherwise have changed; the missing-data amount and reasons are not reported in the registry record.

The recalculated comparisons are simple, unadjusted re-calculations from posted summary statistics. They are useful for understanding the observed pairwise contrasts, but they are not a substitute for the sponsor’s own analysis. The record flags a discrepancy, so the sponsor’s own analysis takes precedence. The registry’s reported result supplies an overall p-value but does not give a sponsor-reported effect estimate or confidence interval for each pairwise contrast. Consequently, the recalculated intervals and p-values should be interpreted as supplementary descriptive analyses, not as the definitive inferential results from the trial.

The record lists 33 outcome measures and 174 analyses, while 32 secondary outcomes are posted. Many outcomes and analyses can create multiplicity: the more statistical questions examined, the greater the chance that some results appear noteworthy by chance if each is interpreted without accounting for the full set. General approaches include defining a primary comparison in advance, adjusting for multiple testing, or treating secondary findings as exploratory. Which approach was specified for this trial is not reported in the registry record. The reported overall Fisher exact test and the recalculated pairwise tests must therefore be distinguished, and no claim about a prespecified multiplicity strategy is warranted.

10. Confidence Intervals and Precision

Precision is limited for the primary endpoint. The 95% confidence interval for the etanercept group percentage is 29.78 to 74.29; for etanercept and acitretin it is 33.5 to 79.75; and for acitretin it is 6.41 to 47.64. Each interval covers a broad range of plausible response percentages under the analysis method. The point estimates alone therefore do not give a precise description of the underlying response frequency.

The pairwise recalculated risk-difference interval for etanercept and acitretin versus etanercept is -0.253 to 0.363. It includes zero and values in both directions, so the estimate is imprecise about the direction and size of the contrast. For acitretin versus etanercept, the recalculated interval is -0.589 to -0.014. This interval is also broad, although its endpoints are below zero. These are unadjusted recalculations, and the discrepancy flag means the sponsor’s own analysis takes precedence.

Confidence intervals are not guarantees that the true value falls within the displayed range. They reflect uncertainty under a statistical method and its assumptions. For proportions and differences estimated from small groups, a limited number of participant outcomes can materially affect the result. The group denominators and broad intervals should be considered together rather than focusing only on the percentage estimates.

The sponsor-reported Fisher exact test gives an overall p-value of 0.067, but the registry record does not provide a confidence interval for that overall analysis. The lack of a reported sponsor estimate and interval for each pairwise contrast limits direct comparison between the overall test and the recalculations. The trial’s original precision targets and sample-size rationale are not reported in the registry record.

11. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size illustrations estimate participants per arm for 80% power and participants per arm for 90% power under stated planning assumptions. They are planning illustrations based on the observed effect, not the trial’s original design calculation. The assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is the stated fraction of the observed effect. The registry record does not report the trial’s own original sample-size assumptions.

For the comparison of etanercept and acitretin with etanercept, planning for 100% of the observed effect gives 1,277 participants per arm for 80% power and 1,708 participants per arm for 90% power. Planning for 75% of the observed effect gives 2,276 and 3,046 participants per arm, respectively. Planning for 50% of the observed effect gives 5,134 and 6,872 participants per arm, respectively.

For acitretin compared with etanercept, planning for 100% of the observed effect gives 40 participants per arm for 80% power and 52 participants per arm for 90% power. Planning for 75% of the observed effect gives 74 and 98 participants per arm, respectively. Planning for 50% of the observed effect gives 170 and 227 participants per arm, respectively.

The 80% power column represents the planned chance of detecting the assumed effect under the calculation’s conditions if that effect is present; the 90% column uses a higher target chance of detection and therefore requires more participants in these illustrations. Smaller effects require more participants because they are harder to distinguish from random variation. The curve can be read as a visual version of this relationship between the effect size used for planning and the required group size. These figures are not observed power, and they do not describe what the completed trial was powered to detect.

12. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.524; treatment proportion p₁ = 0.579; average p̄ = 0.551.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.7034 = 1.3786.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.7023 = 0.5911.
4. n = (1.3786 + 0.5911)² / (0.0551)² = 1,276.0, rounded up to 1,277 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.523809523809524                          # control proportion
p1 <- 0.578947368421053                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(936065)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 1,277 (80% power), 1,708 (90% power)
 75% of observed effect: n per arm = 2,276 (80% power), 3,046 (90% power)
 50% of observed effect: n per arm = 5,134 (80% power), 6,872 (90% power)
power.prop.test: 1276 
Simulated power at n = 1,277 per arm: 0.798 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

13. Analyses Reported by the Sponsor

The registry reports the sponsor’s primary-result analysis as a Fisher exact test across the three groups, with p = 0.067. That overall test evaluates the distribution of PASI 75 responses across all three groups together. The registry record does not provide a sponsor-reported risk difference, confidence interval, or separate p-value for each pairwise comparison in the posted primary result.

The pairwise risk differences, intervals, and p-values are recalculated from posted summary statistics without adjustment. The recalculated comparison of etanercept and acitretin with etanercept has a risk difference of 0.055, a 95% confidence interval of -0.253 to 0.363, and an unadjusted p-value of 0.726. The recalculated comparison of acitretin with etanercept has a risk difference of -0.302, a 95% confidence interval of -0.589 to -0.014, and an unadjusted p-value of 0.054.

The registry flags a discrepancy between the sponsor analysis and the recalculations. Under that circumstance, the sponsor’s own analysis takes precedence. The recalculated estimates can still help describe the posted group counts and pairwise contrasts, but they should not be presented as the sponsor’s reported conclusions or as a replacement for the overall Fisher exact result. The record does not explain the source of the discrepancy, so its cause is not reported in the registry record.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists 33 outcome measures and 174 analyses, and 32 secondary outcomes are posted. These counts indicate a broad set of recorded outcomes and analyses, but the registry record does not explain the difference between the number of listed outcome measures and posted secondary outcomes. It also does not provide a complete statistical analysis plan specifying how the many analyses were intended to be interpreted.

Multiplicity is relevant when several outcomes, comparisons, or analyses are considered. If each is tested separately without adjustment, the chance of at least one apparently unusual result can rise across the set of tests. Common general strategies include defining a primary hypothesis in advance, adjusting significance criteria across multiple tests, or treating additional outcomes as exploratory. The strategy used for this trial is not reported in the registry record. The overall Fisher exact test and the pairwise recalculations should therefore be kept distinct; the recalculated pairwise p-values are unadjusted.

The primary analysis population is the modified intent-to-treat population: randomized participants who took at least one dose and had both baseline and on-therapy PASI evaluations. The primary endpoint uses LOCF. The registry record does not report how many participants had missing assessments, the reasons for missingness, or the sensitivity analyses, if any, used to evaluate the LOCF assumption. LOCF is a stated handling method, but its use does not demonstrate that missingness had no effect on the findings.

The registry record does not report the randomization sequence method, allocation concealment, a detailed analysis plan, or the trial’s original sample-size justification. It also does not identify a prespecified primary pairwise comparison among the three groups. These omissions limit assessment of how the analysis decisions were planned before the results were known. They do not establish that the analyses were inappropriate; they mean that these details cannot be assessed from the registry record.

15. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: back pain (5.6%).

The posted serious adverse event figures are counts of affected participants and participants at risk. In the etanercept group, 0 of 21 participants were reported with a serious adverse event. In the etanercept-and-acitretin group, 0 of 20 were reported with a serious adverse event. In the acitretin group, 1 of 18 was reported with a serious adverse event. The at-risk denominators for these safety figures are not the same as all the primary endpoint denominators, so the safety and efficacy counts should not be conflated.

Back pain is listed among the serious adverse event terms at 5.6%. The registry record does not identify which group this term belongs to in the posted summary, so it cannot be attributed to a particular treatment group from this information. Death counts are not reported in the registry record; a missing count should not be interpreted as confirmation that no deaths occurred.

These figures describe reported events in the recorded safety groups. They do not establish comparative safety, and the small group sizes limit how precisely event rates can be characterized. The record also reports other adverse events, but the serious-event counts should be read separately from those other-event totals.

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

The primary endpoint reports the percentage of participants reaching PASI 75 at week 24 in each analyzed group. The observed percentages were 52.38% for etanercept, 57.89% for etanercept and acitretin, and 22.22% for acitretin. These results describe the participants included in the modified intent-to-treat analysis, with LOCF applied as specified in the registry.

The group percentages have broad confidence intervals, and the recalculated pairwise comparisons are imprecise. The comparison of etanercept and acitretin with etanercept alone has a recalculated interval that spans zero. The comparison of acitretin with etanercept has a recalculated interval from -0.589 to -0.014, but this is an unadjusted calculation and the registry flags a discrepancy. The sponsor’s own analysis takes precedence; its reported overall Fisher exact test has p = 0.067.

These findings do not establish that one treatment works or does not work, and they do not establish equivalence or superiority. A difference in observed percentages is not by itself proof of a true difference. Conversely, an imprecise estimate or an overall test does not prove that groups are the same. The uncertainty intervals, analysis population, design, and distinction between the sponsor’s overall analysis and recalculated pairwise estimates all matter to interpretation.

The primary endpoint is one threshold at one assessment time. It does not provide a complete account of changes in PASI, the timing of response, results on Physician Global Assessment outcomes, or longer-term outcomes. The registry lists secondary outcomes related to PASI 50, Physician Global Assessment categories, and time to achievement, but their results are not described in these primary estimates. The safety figures are also limited event counts and should not be treated as a complete comparative safety assessment.

Overall, the posted primary data give a preliminary picture of response proportions in a randomized, open pilot study. The small analyzed groups and broad intervals make precision limited. Further interpretation is constrained by the missing original sample-size justification, the absence of a detailed analysis plan, the unspecified reason for the discrepancy, and incomplete reporting of missing-data details.

17. Why This Trial Matters Statistically

This trial illustrates why a point estimate and its uncertainty should be read together. The observed PASI 75 percentages differ across groups, but the confidence intervals around those percentages are broad. A ranking based on the point estimates alone would hide the amount of uncertainty in the underlying group proportions.

It also illustrates that an overall three-group test and pairwise comparisons answer different questions. The sponsor-reported Fisher exact test evaluates the distribution across all three groups together. The recalculated risk differences compare two groups at a time and are unadjusted. Because the registry flags a discrepancy, the sponsor analysis takes precedence, and the recalculations should be treated as supplementary rather than as the definitive analysis.

The pilot setting is important statistically. The analyzed groups are small, so estimates can be sensitive to individual outcomes and confidence intervals can remain wide. Planning illustrations based on the observed effects also show how the assumed effect size changes the participant requirements: planning for a smaller fraction of an observed effect requires more participants. Those illustrations are not the original trial design rationale and are not observed power.

The record also shows why analysis-population and missing-data definitions matter. The primary endpoint uses a modified intent-to-treat population and LOCF, but the amount and reasons for missing data are not reported. A result is interpretable only in relation to who contributed data and how unavailable measurements were handled.

Finally, the registry lists many outcomes and analyses but does not report a detailed multiplicity plan. This makes it important to distinguish the primary endpoint and sponsor-reported overall test from additional analyses. The example highlights that statistical interpretation depends not only on the displayed estimates but also on the structure, reporting, and limitations of the analysis.

18. 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.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

This trial has several limitations specific to its design and registry reporting. It was a pilot study with an enrollment of 60, while the primary endpoint was analyzed in groups of 21, 19, and 18 participants. The study was open label, with no masking listed. The registry record does not report the randomization procedure, allocation concealment, or intended allocation ratio.

The arm descriptions are blank, although the official title and brief summary describe the treatment regimens. The detailed regimen-to-group mapping is therefore not reported in the registry record. This limits the ability to connect every group label to the full treatment schedule using the arm descriptions alone.

The primary endpoint uses a modified intent-to-treat population and LOCF. The record does not report the number or pattern of missing assessments, the reasons for missingness, or sensitivity analyses for the LOCF approach. It also does not report the trial’s original sample-size justification or a full statistical analysis plan. The sample-size illustrations are based on the observed effects and stated planning assumptions, not on the trial’s original design.

The record lists 33 outcome measures and 174 analyses, while 32 secondary outcomes are posted. The reason for this difference is not reported in the registry record. A multiplicity strategy and a prespecified primary pairwise comparison are also not reported. The sponsor’s reported result is an overall Fisher exact test, whereas pairwise risk differences are recalculated and unadjusted. Because the record flags a discrepancy, the sponsor’s own analysis takes precedence; the cause of the discrepancy is not reported.

Finally, the group confidence intervals are broad, and serious adverse events are sparse in the recorded safety groups. The death counts are not reported in the registry record. These constraints limit precision and the amount that can be concluded from the posted results.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis — NCT00936065.
• Registry record last updated 2012-04-09; status last verified 2012-03.
• Results first posted 2012-04-09.
• 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.

22. Record Summary

NCT00936065 is a completed, randomized, open-label, parallel-group phase 4 pilot trial in moderate to severe psoriasis. The registry lists 60 enrolled participants and three intervention groups: etanercept, etanercept and acitretin, and acitretin. The primary endpoint was PASI 75 at week 24 in a modified intent-to-treat population, using LOCF.

The observed PASI 75 percentages were 52.38%, 57.89%, and 22.22%, respectively. The sponsor-reported analysis was a Fisher exact test across the three groups, with p = 0.067. Pairwise comparisons are also available as unadjusted recalculations, but the record flags a discrepancy, so the sponsor’s own analysis takes precedence. Broad confidence intervals, small analyzed groups, open-label design, and incomplete reporting of the analysis plan and missing-data details limit interpretation.