Journal of Clinical and Aesthetic Dermatology • Hot Topics in Psoriasis February 2024 • Meeting Highlights

The European Academy of Dermatology and Venerology (EADV) held its 2023 Congress on October 11–14, 2023 in Berlin, Germany. The conference gave researchers, physicians, and members of industry the opportunity to share and learn about the latest developments in dermatology research, including psoriasis. The event included speaker presentations on various clinical topics, as well as posters reporting the latest data from research and clinical trials, including those evaluating psoriasis treatment options and the development of diagnostic and prognostic assessment tools. Summaries of key abstracts from the meeting are included here.

Bimekizumab response through 3 years in patients with plaque psoriasis who stopped and re-started treatment. The Phase III BE READY clinical trial assessed bimekizumab in the treatment of plaque psoriasis. Median time to relapse from last bimekizumab dose, defined as loss of 75-percent or greater improvement in Psoriasis Area and Severity Index (PASI75), in patients who achieved PASI90 at Week 16 was 32 weeks. Here, Costanzo et al assessed bimekizumab response over three years in patients who stopped and restarted treatment. Patients were initially randomized to bimekizumab 320mg every four weeks, rerandomized to receive placebo for the 40-week randomized withdrawal period, then entered the open-label extension (OLE). A total of 105 patients who achieved PASI90 at Week 16 were rerandomized to receive placebo. Thirty-three patients (31.4%) did not relapse for the 40-week placebo period, with 17 patients (51.5%) maintaining PASI90 and 11 (33.3%) reaching PASI100 at Week 56. Following retreatment with bimekizumab, PASI90 was reached by 31 of 32 patients (96.9%) and PASI100 was achieved by 26 of 32 patients (81.3%) at OLE Week 48. At OLE Week 96, after patients had switched to bimekizumab treatment every eight weeks, 27 of 28 (96.4%) patients achieved PASI90, and 24 of 28 (85.7%) patients achieved PASI100. Sixty-six patients (62.9%) experienced relapse after rerandomization to placebo and entered a 12-week escape arm, after which 90.8 (n=59/65) and 63.1 percent (n=41/65) of patients reached PASI90 and PASI100, respectively. At OLE Weeks 48 and 96, 58 of 60 (96.7%) and 55 of 59 (93.2%) patients, respectively, achieved PASI90, and 50 of 60 (83.3%) and 46 of 59 (78%) patients, respectively, achieved PASI100. This study showed that stopping and restarting bimekizumab therapy did not significantly effect long-term psoriasis control.

Roflumilast foam 0.3% in patients with scalp and body psoriasis in the Phase III ARRECTOR trial: efficacy, patient-reported outcomes, and safety. In this Phase III clinical trial, patients aged 12 years or older with scalp and body psoriasis and an overall affected body surface area (BSA) of 25 percent or less were randomized to receive roflumilast foam 0.3% (n=281) or vehicle (n=151) once per day for eight weeks. Scalp- (S-IGA) and Body-Investigator’s Global Assessment (B-IGA) success were achieved by significantly more patients treated with roflumilast foam (66.4% and 45.5%, respectively) at Week 8, compared to those treated with vehicle (27.8% and 20.1%, respectively). Additionally, 50.1 percent of patients treated with roflumilast foam achieved PASI75 at Week 8, compared to 16.8 percent of vehicle-treated patients. Significantly more patients in the roflumilast cream group experienced a four-grade or higher improvement in Scalp Itch- (SI-NRS) and Worst Itch-Numerical Rating Score (WINRS), compared to patients in the vehicle group. Compared to vehicle-treated patients, significantly more patients treated with roflumilast foam reported a score of 0 for the Psoriasis Symptom Diary total score, as well as for the items of severity of psoriasis-related scaling, itch, and pain, at Week 8. The rate of adverse events (AEs) was low in both groups (roflumilast foam: 2.5%; vehicle: 1.3%).

A US claims database analysis estimating risk of all-cause mortality in patients with generalized pustular psoriasis. In this study, Gottlieb et al compared all-cause mortality among patients with generalized pustular psoriasis (GPP), patients with plaque psoriasis, and the general population without GPP or plaque psoriasis. The majority of all participants were female and had commercial insurance. All patients with GPP (including those with comorbid GPP and plaque psoriasis) had a significantly increased risk of mortality at one-year follow-up, compared to the general population and patients with plaque psoriasis alone. Compared to patients with plaque psoriasis alone, patients with comorbid GPP and plaque psoriasis had significantly higher mortality risk, whereas those with GPP alone had a numerically, but nonsignificantly, higher risk of mortality. However, at maximum follow-up, the difference between the GPP alone and plaque psoriasis alone cohorts was significant. Additionally, at maximum follow-up, the all GPP cohort had a four- and 1.5-times increased risk of mortality, compared to the general population and plaque psoriasis only cohorts, respectively.

Comparative analysis of cardiovascular risk in psoriasis: assessing disparities between Black/African American and White non-Hispanic patients. Here, Garate et al conducted a retrospective cohort analysis to determine differences in cardiovascular outcomes between Black and White non- Hispanic patients with psoriasis. Data from 30,057 matched patients were analyzed. The authors adjusted for age at index and potential confounders, including essential hypertension, family history of ischemic heart disease/ other circulatory system diseases, diabetes, nicotine dependence, overweight/obesity, and alcohol-related disorders. Compared to White non-Hispanic patients, Black patients experienced an increased risk of all studied cardiovascular outcomes, which included cardiac arrest, cerebral infarction, heart failure, acute myocardial infarction, and other venous embolism and thrombosis, at one-, five-, and 10-years postdiagnosis.

Healthcare resource utilization and costs among patients with generalized pustular psoriasis: a US claims analysis. This study compared all-cause healthcare resource utilization (HCRU) among patients with GPP alone, patients with plaque psoriasis alone, and patients with comorbid GPP and plaque psoriasis. Rates of all-cause inpatient stays, emergency room (ER) visits, office visits, and outpatient visits were significantly higher in the all GPP and comorbid GPP and plaque psoriasis groups, compared to the plaque psoriasis alone cohort. In addition, patients with GPP alone experienced significantly higher all-cause stays/visits of all types, except office visits, compared to those with plaque psoriasis alone. The all GPP and comorbid GPP and plaque psoriasis cohorts had significantly greater inpatient/ER and outpatient/office costs than the plaque psoriasis alone cohort; prescription costs did not differ significantly between the groups. Total all-cause costs were higher in the comorbid GPP and plaque psoriasis group, compared to the plaque psoriasis group. All-cause outpatient/office costs were significantly higher among patients with GPP alone, compared to those with plaque psoriasis alone. The plaque psoriasis alone cohort had significantly higher all-cause total costs and all-cause prescription costs, compared to the GPP alone cohort.

Efficacy and safety results from the randomized, double-blind, placebocontrolled Phase IIb trial of the oral TYK2 inhibitor TAK-279 in moderate-to-severe psoriasis. In this Phase IIb trial, 259 adult patients with moderate-to-severe plaque psoriasis were randomized to receive TAK-279 (2mg, 5mg, 15mg, or 30mg) or placebo once per day for 12 weeks. A total of 44, 68, and 67 percent of patients who received TAK-279 5mg, 15mg, and 30mg, respectively, experienced PASI75 at Week 12, whereas only six percent of patients who received placebo achieved PASI75; these differences were significant. Zero percent of patients in the placebo group achieved PASI90 or PASI100. Twenty-one and 10 percent of patients who received TAK-279 5mg achieved PASI90 and PASI100, respectively. In the TAK-279 15mg and 30mg treatment arms, 45 and 46 percent of patients, respectively, achieved PASI90, and 15 and 33 percent, respectively, achieved PASI100. AE frequency was 44 percent in the placebo arm and ranged from 53 to 62 percent in the treatment arms. Infection, acne/acneiform dermatitis, and diarrhea were the most frequent AEs.

Evaluating prevalence and consequence of residual disease among patients with moderate-to-severe psoriasis in the United States. Here, Armstrong et al assessed the impact of residual disease in US patients with moderate-to-severe psoriasis treated with apremilast. Residual disease was defined as affected BSA of three percent or greater or reported moderate, severe, or very severe psoriasis on a six-point severity scale. Among 344 patients, 50.6 percent experienced residual disease over the past week. Odds of having residual disease were higher among Black patients, compared to White patients; patients with a treatment duration of one year or longer, compared to those with a shorter treatment duration; patients with four or more affected body regions, compared the those with 1 to 3; and patients who experienced two or more disease flares within the previous three months, compared to those who experienced fewer disease flares. Mean number of disease flares over the past three months was 4.7 for those with residual disease, compared to only 0.9 for those without residual disease. Rates of anxiety and depression within the past 30 days were significantly higher among patients with residual disease, compared to those without residual disease; depression severity was also significantly higher among patients with residual disease. All-cause and psoriasis-related HCRU was increased in patients with residual disease as well.

RESEARCH BITE—Predictive factors of psoriatic arthritis in a diverse population with psoriasis

Among 330 patients with psoriasis, 83 (25%) developed psoriatic arthritis. Patients with psoriatic arthritis had significantly higher rates of oral systemic therapy use and nail involvement, compared to those with psoriasis only. Multivariate analysis identified female sex, nail involvement, severe psoriasis, and treatment with previous oral systemic therapy as significant predictors for psoriatic arthritis.

Source: Loo WY, Tee YC, Han WH, et al. Predictive factors of psoriatic arthritis in a diverse population with psoriasis. J Int Med Res. 2024;52(1):3000605231221014.