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Home NEWS Science News Health

Real-World Psoriasis Study Finds Patients Treated Below Clinical Trial Severity Thresholds

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October 29, 2026
in Health
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Real-World Psoriasis Study Finds Patients Treated Below Clinical Trial Severity Thresholds

Real-World Psoriasis Study Finds Patients Treated Below Clinical Trial Severity Thresholds

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A large survey of US dermatology practices has found that many patients with psoriasis begin advanced systemic therapies at disease severity scores well below the thresholds traditionally required to enter clinical trials, and that physicians report noticeably less satisfaction with advanced oral treatments than with injectable biologics. The study, published in Dermatology and Therapy, analyzed linked physician and patient questionnaire data from the 2024 Psoriasis Wave XI of the Adelphi Real World Disease Specific Programme in the United States, offering a snapshot of how psoriasis is actually treated outside the tightly controlled environment of randomized trials.

The analysis included 682 adults with physician-confirmed psoriasis who were not enrolled in clinical trials at the time of the survey. Dermatologists completed patient record forms for consecutively consulting patients, and the patients themselves filled out linked self-completion questionnaires on the same day. Of the total, 466 patients, or 68.3 percent, were judged by their physicians to have mild disease, while 216 patients, or 31.7 percent, were classified as moderate-to-severe. Severity classification rested entirely on the physician’s clinical judgment at the time of consultation, with no standardized criteria specified, a deliberate choice intended to reflect everyday practice.

Among the 517 patients receiving advanced systemic therapies, 134, or 25.9 percent, were on advanced oral therapies such as apremilast or deucravacitinib, while 383, or 74.1 percent, were receiving biologics or biosimilars. Before starting their current treatment, the two groups had similar mean body surface area involvement, at 13.4 percent for the oral therapy group versus 14.7 percent for the biologics group, a difference that was not statistically significant. Mean Psoriasis Area and Severity Index scores, however, were lower in the oral therapy group, at 6.2 versus 9.3, a highly significant difference that reflected greater baseline severity among patients placed on biologics.

The most striking finding concerned how these baseline scores compared with clinical trial entry requirements. Mean PASI scores before treatment initiation fell below the 12-point cutoff commonly used to enroll patients in pivotal psoriasis trials, even though mean body surface area involvement exceeded the 10 percent threshold often used to define moderate-to-severe disease. For example, the LIBERATE trial of apremilast required both PASI of at least 12 and body surface area involvement of at least 10 percent for inclusion. The study’s authors argue that this mismatch excludes patients with substantial real-world burden, particularly those with involvement of high-impact sites, despite lower overall scores.

High-impact site involvement was indeed common. At the start of current treatment, roughly two-thirds of patients across severity levels had disease affecting areas such as the scalp, groin or genitals, palms, soles, nails, or armpits, with 63.9 percent of the mild group and 67.0 percent of the moderate-to-severe group affected, a difference that was not statistically significant. Such involvement is associated with disproportionate physical and psychological burden even when total skin involvement is limited. The International Psoriasis Council now recommends systemic therapy for patients with psoriasis in these high-impact locations regardless of PASI or body surface area scores, a position the study’s findings appear to reinforce.

At the time of consultation, residual disease burden remained higher in the moderate-to-severe group than in the mild group, with mean body surface area involvement of 10.7 percent versus 3.0 percent and mean PASI of 7.9 versus 2.0, both differences statistically significant. Physicians reported satisfaction with current treatment control for 79.0 percent of mild patients, but for only 26.0 percent of moderate-to-severe patients did they believe the current treatment provided the best realistically achievable control. Among moderate-to-severe patients, 31.0 percent were described as dissatisfied with treatment, compared with just 3.0 percent of mild patients.

Satisfaction also differed by treatment class. Physicians reported satisfaction with the control provided by advanced oral therapies in 50.0 percent of patients, compared with 75.0 percent of those on biologics. Patient-reported responses followed a similar pattern: 59.0 percent of patients on advanced oral therapies said they were completely satisfied and believed their treatment had achieved the best possible result, versus 70.0 percent of biologic patients, while 37.0 percent of oral therapy patients reported being satisfied but felt their medication could perform better. Agreement between physician and patient satisfaction was moderate in both groups, with kappa values of 0.434 for advanced oral therapies and 0.593 for biologics.

Treatment history shed light on how patients arrive at these regimens. Among patients with prior treatments now on advanced oral therapies, 76.5 percent had previously received topicals or phototherapy, and only 11.8 percent had previously been on another advanced oral therapy. Among biologic patients with prior treatments, 59.3 percent had received topicals or phototherapy and 34.1 percent had previously been on biologics, suggesting considerable persistence within that drug class. When patients did switch, physicians most often cited primary lack of efficacy, reported for nearly half of switchers in both groups, at 46.7 percent for those moving to advanced oral therapies and 46.9 percent for those moving to biologics.

The authors are careful to frame the study as descriptive rather than inferential. All analyses were bivariate, with no adjustment for potential confounders such as differences in baseline characteristics or prior treatments, and no corrections for multiple comparisons. The cross-sectional design captured a single time point with no longitudinal follow-up, retrospective severity data relied on physician recall and medical records, and the sample of consecutively enrolled patients from volunteer dermatologists may overrepresent frequent healthcare users. Severity classifications were not validated against standardized criteria. The findings should therefore be read as hypothesis-generating descriptions of real-world practice, not as evidence about the comparative efficacy or safety of one treatment class over another.

Even with those caveats, the study adds a meaningful data point to an ongoing debate about who qualifies for advanced psoriasis therapy. Patients in routine US practice were initiated on systemic treatments at PASI scores below conventional trial-entry thresholds even when body surface area involvement, physician-assessed severity, and high-impact site disease pointed to clinically meaningful burden, suggesting that trial eligibility criteria capture a narrower, higher-PASI population than the patients dermatologists actually treat. The authors conclude that broader, more patient-centered eligibility standards may better reflect real-world disease burden, and that suboptimal satisfaction among some patients, particularly those on advanced oral therapies, points to a continuing unmet need that newer and more efficacious oral options may need to address.

Subject of Research: Real-world treatment outcomes and satisfaction in psoriasis patients receiving biologics or advanced oral therapies

Article Title: Real-World Patient and Disease Characteristics, Treatment Outcomes and Satisfaction in Psoriasis: A Cross-Sectional and Retrospective Comparison of Advanced Therapies and Severities

Article References: Stein Gold, L., Sofen, H. L., Siu, K., Syeed, S., Edson-Heredia, E., Mitchell, B., Goddard, E., Kranz, B., Gillespie-Akar, L., & Armstrong, A. W. (2026). Real-World Patient and Disease Characteristics, Treatment Outcomes and Satisfaction in Psoriasis: A Cross-Sectional and Retrospective Comparison of Advanced Therapies and Severities. Dermatology and Therapy. https://doi.org/10.1007/s13555-026-01899-4

Image Credits: AI Generated

DOI: 10.1007/s13555-026-01899-4

Keywords: psoriasis, biologics, advanced oral therapies, PASI, body surface area, treatment satisfaction, real-world evidence, cross-sectional study, dermatology, clinical trial eligibility, high-impact sites, Adelphi Real World

News Source: Ophelia Keating. (October 29, 2026). Real-World Psoriasis Study Finds Patients Treated Below Clinical Trial Severity Thresholds. Scienmag.

Tags: Adelphi Real Worldadvanced oral therapiesBiologicsbody surface areaclinical trial eligibilityCross-sectional StudyDermatologyhigh-impact sitesPASIpsoriasisReal-world evidencetreatment satisfaction
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