Psoriatic Disease Clinical Trial Updates

Psoriasis affects more than 7.5 million adults in the United States.¹ About 30% of patients with psoriasis develop psoriatic arthritis;² however, plaque psoriasis—also called psoriasis vulgaris—is the most common form. These patients develop raised plaques and scales on the skin, which may itch, burn, or sting.³ Psoriatic plaques can appear on any area of the body, but are most commonly seen on the elbows, knees, and scalp.³ Psoriasis can begin at any age, but it typically arises between ages 15 and 25 years.³ Individuals with psoriasis are at a higher risk for comorbidities, such as cardiovascular disease, depression and other mental health issues, and metabolic diseases such as type 2 diabetes.⁴ In addition to physical symptoms, psoriasis can have a significant impact on a person’s quality of life and psychological health.⁴

The following trials observed the efficacy and tolerability of treatments being studied for patients with psoriasis and psoriatic arthritis. These trials are essential to improve symptom management and quality of life in patients with psoriatic disease.

POETYK PSO Long-Term Extension Trial 2-Year Results

The results of the POETYK PSO long-term extension (LTE) trial were presented at the European Academy of Dermatology and Venereology Spring Symposium from May 12 to 14, 2022, demonstrating durable efficacy and a consistent safety profile for deucravacitinib treatment among adults with moderate to severe plaque psoriasis. Clinical efficacy was maintained for up to 2 years of treatment, with response rates at week 60 of 77.7% for Psoriasis Area and Severity Index (PASI) 75 and 58.7% for the static Physician Global Assessment (sPGA) score of 0/1 (clear/almost clear skin).⁵

Deucravacitinib is an oral, selective, small-molecule TYK2 inhibitor that binds to the regulatory domain of TYK2. For this reason, it is thought to have a more selective mechanism of action.⁶ The global phase 3 trials, POETYK PSO-1 and POETYK PSO-2, first evaluated the safety and efficacy of deucravacitinib among patients with moderate to severe plaque psoriasis in a total of 666 and 1020 participants, respectively.⁵ The coprimary outcome measures of both trials were the percentage of participants who achieved PASI 75 and an sPGA score of 0 to 1 at week 16 vs placebo. The POETYK PSO-2 trial concluded that deucravacitinib had a robust efficacy against placebo and achieved its primary end point.⁷ Participants had the option of enrolling in the POETYK PSO LTE trial following the 52-week POETYK PSO-1 and POETYK PSO-2 trials. A total of 1221 patients in the POETYK PSO LTE trial received at least 1 dose of deucravacitinib, 6 mg daily.⁵

Tapinarof Cream, 1% FDA Approved for Plaque Psoriasis

The US Food and Drug Administration (FDA) recently approved tapinarof cream, 1% for adults with plaque psoriasis.⁸

Tapinarof cream, 1% is a topical aryl hydrocarbon receptor-modulator. In the phase 3 PSOARING 1 and 2 trials, it was superior to the vehicle control in reducing the severity of plaque psoriasis when administered once daily over a 12-week period.⁹ Adverse events were local and included folliculitis, nasopharyngitis, contact dermatitis, headache, upper respiratory tract infection, and pruritus.⁹ Tapinarof cream, 1% demonstrated a highly statistically significant improvement in the Physician Global Assessment score of 0 (clear) or 1 (almost clear), plus a 2-grade or greater improvement from baseline compared with the vehicle at week 12 among 36% of participants receiving tapinarof cream, 1% vs 6% receiving the vehicle (PSOARING 1) and 40% of those receiving tapinarof cream, 1% vs 6% receiving the vehicle (PSOARING 2).⁸ There was also a 75% or greater reduction in the PASI score from baseline at week 12.⁸ Lastly, in the PSOARING 3 LTE trial, tapinarof cream, 1% demonstrated safety and tolerability consistent with PSOARING 1 and PSOARING 2, with improvement continuing beyond 12 weeks.¹⁰

Bimekizumab’s BE COMPLETE Trial Update

Data were recently presented from the BE COMPLETE trial of bimekizumab, a monoclonal IgG1 antibody that selectively inhibits IL-17A and IL-17F.11 The 16-week phase 3 trial aimed to assess the efficacy and safety of bimekizumab vs placebo among patients with active psoriatic arthritis and a previous inadequate response to a tumor necrosis factor (TNF) inhibitor.¹¹ Bimekizumab was compared with placebo in a cohort of 400 patients, 263 treated with bimekizumab and 125 who received a placebo.¹¹ Eligible participants had 3 or more swollen and tender joints and previous intolerability or failures with TNF inhibitor treatment. PASI scores and American College of Rheumatology (ACR) responses were used to determine outcomes.¹²

Primary end point results showed that 43.4% of the patients achieved ACR 50 with bimekizumab compared with 6.8% for placebo;¹¹ 68.8% of the patients achieved PASI 90 compared with 6.8% for placebo.¹² The ACR 20 response was 67% for bimekizumab and 15.8% for placebo, whereas the ACR 70 response was 26.6% in bimekizumab and 0.8% for placebo. Bimekizumab surpassed placebo in the PASI 75 (82.4% vs 10.2%) and PASI 100 (58.5% vs 4.5%) scores.¹² It also surpassed placebo in minimal disease activity.¹² Additionally, week 16 outcomes demonstrated numerical improvement with bimekizumab compared with placebo.¹¹

“Dual inhibition of IL-17A and IL-17F with bimekizumab in patients with active psoriatic arthritis and prior inadequate TNF inhibitor response resulted in rapid, clinically relevant, and statistically significant improvements in efficacy outcomes vs placebo. No new safety signals were observed,” concluded study authors.¹¹

FDA Approves Roflumilast Cream, 0.3% for Plaque Psoriasis

The FDA recently approved the selective phosphodiesterase-4 inhibitor roflumilast cream, 0.3% as a nonsteroidal topical treatment for plaque psoriasis in patients aged 12 and older.¹³ Results from the DERMIS phase 3 trials of roflumilast cream were announced at the 2022 American Academy of Dermatology Annual Meeting from March 25 to 28, 2022.¹⁴ Roflumilast cream was well-tolerated among patients with psoriasis in steroid-sensitive areas, such as the face, neck, and intertriginous areas, and it showed significant improvements in investigator- and patient-assessed outcomes.¹⁵

In the DERMIS 1 and DERMIS 2 trials, the primary end point was achieved, with roflumilast cream demonstrating an Investigator Global Assessment (IGA) success rate of 46.4% vs 6.1% in the vehicle (DERMIS 1) and 37.5% vs 6.9% in the vehicle (DERMIS 2).¹⁶ At week 6, the IGA score indicated clear or almost clear skin in 28% of the patients receiving 0.3% roflumilast cream, 23% of the patients receiving 0.15% roflumilast cream, and 8% of the patients receiving the vehicle.^17,18 At week 8, 40% of participants achieved IGA success and a 2-grade or greater improvement from baseline with roflumilast cream vs 7% of patients with the vehicle; 48% of participants achieved clear or almost clear skin with roflumilast cream vs 10% with the vehicle.¹⁴ At week 12, IGA score success and 2-grade improvement from baseline were observed in 31% of the patients receiving 0.3% roflumilast cream, 27% of the patients receiving 0.15% roflumilast cream, and 14% of patients receiving the vehicle.¹⁷ Participants also experienced improvements on the Worst Itch Numeric Rating Scale and the Psoriasis Symptom Diary score.¹⁵ The rate of treatment-related adverse events was low, and the severity of most cases was mild to moderate.¹⁵

Awareness Is Key

August is Psoriasis Awareness (or Action) Month, and awareness is essential for encouraging further research and clinical trials to improve quality of life for the 125 million people around the world impacted by psoriatic disease.^19,20 As a result of successful clinical trials, the FDA approved tapinarof cream, 1% for adults with plaque psoriasis and roflumilast cream, 0.3% for plaque psoriasis in patients aged 12 and older. And current clinical trials have found that deucravacitinib demonstrated consistent efficacy and safety as a treatment for adults with moderate to severe plaque psoriasis and bimekizumab consistently surpassed the placebo in treating active psoriatic arthritis among patients with previous inadequate responses to TNF.