PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept (NCT00527072), a non-randomized phase 3 study. The primary outcome is Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0).

2. Clinical Question

3. Trial Design

This was a phase 3, multicenter, open-label study of infliximab for plaque psoriasis in patients described as having an inadequate response to etanercept. The registry identifies the allocation as non-randomized and the model as single group. These features mean that the study was not organized as a randomized comparison between infliximab and a concurrent control treatment. Participants and study staff were not masked.

The listed intervention was infliximab. The arm description specifies open-label infusions of 5 mg/kg at Weeks 0, 2, 6, 14, and 22. The registry lists enrollment of 217 and a completed status. The recorded start was 2007-07 and the primary completion was 2009-05.

The primary outcome was the number of patients achieving a PGA score of Minimal (1) or Clear (0) at Week 10. The registry also lists secondary outcomes for the number of patients achieving a PASI 50 response at Week 10 and Week 26. It reports three outcome measures and three analyses, but the outcome estimates and analysis details are not reported in the registry record.

In a single-group study, changes observed after treatment cannot be separated as readily from other influences as they can in a well-conducted randomized comparison. General statistical context: a concurrent control group helps distinguish treatment-period changes from background variation, changes over time, and other factors that may affect outcomes. This design can describe what was recorded among participants receiving the study intervention, but it does not by itself establish what would have happened to comparable participants under an alternative condition.

The record describes the study’s purpose as testing infliximab safety and effectiveness among patients with an inadequate response to etanercept. It does not report the detailed protocol, the rationale for the enrollment target, or the statistical analysis plan. Those details should not be inferred from the phase designation or the general study description.

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: This analysis is based on the evaluable population that includes the all enrolled patients who received at least one infliximab infusion, and had a baseline PGA score greater than 1.

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 Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0), measured over Week 10.

The primary endpoint is a count: the number of patients who achieved a PGA score of Minimal (1) or Clear (0) at Week 10. PGA is a physician’s global assessment of psoriasis severity. In this endpoint, the two specified score categories define the response threshold; the outcome does not describe the full range of possible PGA scores or the magnitude of change for each patient.

A categorical endpoint can make a clinical assessment easier to summarize as a clearly defined response status. It also discards some detail: patients with different scores outside the response categories are grouped together as not achieving the endpoint, even if their scores or symptoms differ. General statistical context: this kind of threshold outcome is useful for answering whether participants reached a specified state, but it should not be mistaken for a complete account of symptom change or disease severity.

The registry specifies that patients without a Week 10 PGA score count as not having achieved Minimal or Clear. It also explicitly classifies treatment failures before Week 10 as non-achievers. The endpoint analysis population comprises enrolled patients who received at least one infliximab infusion and had a baseline PGA score greater than 1.

The registry record does not report the primary endpoint count, the proportion of the analysis population achieving the endpoint, or an uncertainty interval. Therefore, the endpoint definition is available, but the magnitude and precision of the Week 10 result cannot be evaluated from the posted record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a count endpoint represent?

The primary outcome is recorded as a number of participants meeting a defined condition: a PGA score of Minimal (1) or Clear (0) at Week 10. A count gives the number of observed participants classified as responders under that rule. For interpretation, the count is ordinarily considered alongside the size and definition of the analysis population. Here, the registry defines the population but does not report the primary count or the population size for that analysis, so a response proportion cannot be assessed.

General statistical context: binary outcomes classify each person into one of two categories, such as meeting or not meeting a response definition. A count is a natural way to report such an outcome. A proportion can add context by relating that count to a denominator, while an uncertainty interval can express the precision of the estimate. The registry record does not report those primary outcome quantities.

How should the missing-score rule be understood?

The registry specifies that a patient without a Week 10 PGA score is treated as not having achieved the endpoint. It also classifies treatment failures before Week 10 as non-achievers. This is an outcome-handling rule, not a statement that every missing value reflects a known clinical outcome. It defines how those cases are counted for this endpoint.

General statistical context: missing outcome data can affect interpretation because the reason for a missing assessment may be related to a participant’s condition, treatment experience, or other factors. Treating missing assessments as failures is one way to produce a defined analysis, but its implications depend on the amount and pattern of missingness. The registry does not report the number of missing Week 10 PGA assessments or describe additional sensitivity analyses, so the impact of this rule cannot be evaluated from the record.

What can a single-group design estimate?

The study is identified as non-randomized and single group. In principle, a single-group analysis can summarize outcomes among participants treated in the study. However, a result in one group is not a direct estimate of the difference between infliximab and a concurrent alternative. Participants’ prior inadequate response to etanercept describes eligibility and treatment history; it does not create a randomized comparison between the two treatments.

General statistical context: random allocation helps balance measured and unmeasured characteristics between treatment groups on average. Without randomization and a concurrent comparator, differences between an observed outcome and what might have occurred otherwise can reflect multiple influences. For this reason, descriptive outcomes and comparative treatment effects are distinct statistical quantities.

What does statistical precision mean?

Precision concerns how much uncertainty surrounds an estimate. General statistical context: a confidence interval expresses uncertainty using the data and a specified statistical method; narrower intervals generally indicate greater precision than wider intervals. Precision depends on factors such as the amount of information and the variability of the outcome. No confidence interval or other uncertainty estimate for the primary endpoint is reported in the registry record, so its precision cannot be described.

The record lists a sample-size planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial itself used that design. The stated illustration is not observed power, and its assumptions do not turn a single-group trial into a randomized comparison. The record does not report the trial’s own sample-size justification.

What is not available about the analysis?

The registry records three outcome measures and three analyses, but does not report the analysis methods or numerical efficacy results. The statistical analysis plan, any prespecified adjustment strategy, and the handling of multiple outcome tests are not reported in the registry record. General statistical context: an analysis plan clarifies how outcomes, populations, missing data, and uncertainty are handled before results are interpreted. Without those details, readers cannot determine whether the posted analyses followed a prespecified approach or how multiple outcomes were addressed.

The record also does not report whether interim analyses were conducted. Such procedures should not be assumed from the phase or the study dates. Likewise, no adjustment for baseline characteristics, subgroup analysis, or model-based estimate should be inferred unless it is described in the registry.

Finally, the listed safety counts are descriptive. General statistical context: adverse event counts can be useful for characterizing what was recorded during a study, but interpretation depends on consistent definitions, follow-up, and exposure information. A count alone does not establish causality or provide a comparative risk estimate. The registry does not report a control group against which these safety counts could be compared.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Infliximab")
n      <- c(211)
events <- c(138)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Infliximab  211  138  65.4  58.6  71.8  58.8  71.5  58.8  71.5

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary Week 10 PGA endpoint and secondary PASI 50 outcomes at Week 10 and Week 26. It also reports three outcome measures and three analyses. The numerical results and detailed analysis methods are not reported in the registry record. The record does not state how the analyses were organized, whether any formal adjustment was planned for multiple outcomes, or how any such adjustment would affect interpretation.

General statistical context: when several outcomes or analyses are examined, the chance of finding an apparently notable result can change, depending on the analysis strategy. Prespecifying a primary outcome and explaining how other outcomes will be handled helps readers distinguish confirmatory questions from additional analyses. The registry identifies a primary endpoint, but the complete multiplicity approach is not reported in the registry record.

The Week 10 endpoint definition assigns patients without a Week 10 PGA score, including treatment failures before that time, to the non-achiever category. This gives a stated rule for the primary outcome, but the number of affected patients is not reported. The registry also does not report further sensitivity analyses or detail how missing values were handled for the PASI outcomes.

The primary analysis population is described as enrolled patients who received at least one infliximab infusion and had a baseline PGA score greater than 1. The registry does not provide the number of patients in that population or report how many enrolled patients were excluded from it. The extent to which the evaluable population differed from total enrollment therefore cannot be assessed from the record.

In general, analysis populations and missing-data rules affect which participants contribute to an estimate and how the result should be understood. The record’s definition is useful, but it is not a substitute for the missing analysis counts, results, and supporting methodological details.

12. 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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: myocardial ischaemia (0.5%), gastritis (0.5%), bursitis infective (0.5%), cellulitis (0.5%), squamous cell carcinoma (0.5%).

The registry reports 8 patients affected by serious adverse events among 215 at risk in the infliximab group. It reports 63 patients affected by other adverse events among 215 at risk. These are descriptive figures for the study group. The registry does not provide a concurrent control group for comparison, and the counts do not by themselves establish that an event was caused by infliximab.

The listed serious adverse event terms are myocardial ischaemia, gastritis, infective bursitis, cellulitis, squamous cell carcinoma, and squamous cell carcinoma of the cervix. Each term is accompanied by a reported value of 0.5%. These entries indicate the terms and values recorded; they do not provide a complete account of event timing, clinical course, or individual participant circumstances.

The deaths field is not reported in the registry record. The posted safety information also does not, by itself, establish how risks compare with another treatment or with no treatment. General statistical context: safety counts are interpreted in light of event definitions, follow-up, exposure, and the population under observation. A count among participants at risk is a descriptive result, not a causal comparison.

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

The registry record identifies a completed phase 3 study of open-label infliximab in patients with plaque psoriasis who had an inadequate response to etanercept. It describes the treatment schedule and defines a Week 10 PGA response as a score of Minimal (1) or Clear (0). It also specifies that missing Week 10 assessments and treatment failures before that time count as non-achievement for this endpoint.

Those details explain the question the study set out to address, but the record does not report the primary endpoint count or a corresponding estimate of uncertainty. The listed PASI 50 secondary outcomes also have no numerical results in the registry record. Therefore, the posted information does not establish how often the defined responses occurred or how precisely they were estimated.

The study’s single-group, non-randomized design is also important. Even if outcome counts were available, they would describe participants treated in this study rather than provide a randomized comparison with a concurrent alternative. Prior inadequate response to etanercept gives context for the enrolled population; it does not allow the study to estimate a comparative treatment effect against etanercept.

The safety counts describe adverse events recorded in the infliximab group. They do not establish that infliximab caused a particular event, nor do they show how the figures compare with another treatment group. The serious adverse event term values should be read as registry entries, not as a complete characterization of overall safety.

General statistical context: a treatment effect is a comparison between outcomes under different conditions, while a single-group outcome is a description of what happened among participants in one condition. Neither the study’s phase nor its stated purpose supplies missing numerical results or a control-group comparison. The conclusions should therefore remain limited to the study design, endpoint definitions, and safety information actually reported.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of the distinction between a clearly stated research question and a result that can be quantitatively interpreted. The registry defines a patient population, an intervention schedule, and a primary response threshold. It also sets out how missing Week 10 PGA values and early treatment failures are classified. These elements are necessary to understand what the endpoint was intended to count.

At the same time, the numerical primary and secondary outcomes are not reported in the registry record. Without those results, readers cannot assess the observed response counts, their uncertainty, or the degree to which the results might be compatible with different underlying outcomes. A defined endpoint is not itself evidence about its frequency.

The design makes a separate statistical point. A non-randomized single-group study can summarize the experience of participants receiving the intervention, but it does not supply the same comparative evidence as a randomized study with a concurrent control group. The history of inadequate response to etanercept identifies the clinical context, not an active comparison arm.

The registry also illustrates why safety counts require careful framing. Counts of serious and other adverse events are useful descriptions, but a single-group record cannot directly establish relative risk versus another treatment. Event terms and percentages add detail, yet they do not answer questions about causation or comparative safety on their own.

Finally, the record’s planning-illustration assumptions should be kept separate from the actual trial design and from observed outcomes. Planning calculations are not observed power, and they cannot replace reported estimates. Together, these distinctions help readers avoid treating endpoint definitions, descriptive safety counts, and planning assumptions as if they were comparative efficacy results.

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 most direct limitation of the posted record is that numerical results for the primary endpoint are not reported. The endpoint definition is available, but the response count, analysis-population size, estimate, and uncertainty are not. Results for the listed PASI 50 outcomes are also not reported. This prevents quantitative assessment of the study’s efficacy outcomes from the registry record.

The design was non-randomized and single group, with no concurrent control arm. As a result, the record does not provide a direct randomized comparison with an alternative treatment or control condition. The participants’ prior inadequate response to etanercept does not resolve this limitation because etanercept was not a concurrent randomized comparator in the study.

The primary analysis population is described, and missing Week 10 PGA assessments and early treatment failures are assigned to the non-achiever category. However, the number of patients in the analysis population, the number with missing assessments, and the number classified as treatment failures are not reported in the registry record. The impact of these features on the endpoint estimate cannot be assessed.

The registry does not report the detailed statistical analysis plan, the trial’s sample-size justification, any interim analyses, or the approach to multiplicity. It also does not provide a detailed account of follow-up or the analysis methods for the listed secondary outcomes. These details should not be inferred from the phase designation or outcome titles.

For safety, the record reports counts and selected serious adverse event terms but does not provide a concurrent comparison group. The deaths field is not reported in the registry record. The posted information therefore supports a limited descriptive reading and does not establish causal or comparative safety conclusions.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept — NCT00527072.
• Registry record last updated 2012-09-03; status last verified 2012-08.
• Results first posted 2010-06-24.
• 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

NCT00527072 is a completed phase 3, multicenter, open-label, non-randomized, single-group study of infliximab in patients with plaque psoriasis who had an inadequate response to etanercept. The recorded start was 2007-07, primary completion was 2009-05, and enrollment was 217.

The intervention was open-label infliximab at 5 mg/kg by infusion at Weeks 0, 2, 6, 14, and 22. The primary endpoint was the number of patients with a Week 10 PGA score of Minimal (1) or Clear (0). The registry defines the analysis population and classifies missing Week 10 assessments and treatment failures before that time as non-achievers.

Secondary outcomes were PASI 50 response counts at Week 10 and Week 26. Numerical efficacy results and uncertainty estimates are not reported in the registry record. Safety information includes 8 affected by serious adverse events and 63 affected by other adverse events among 215 at risk; no concurrent control group is listed.