Patients reported improvements in symptoms and health-related quality of life as early as week 4 and through 3 years in a recent study.

In the multicenter, randomized phase IIIb BE RADIANT clinical trial, researchers recruited 743 patients with moderate to severe plaque psoriasis who were assigned at baseline to receive either bimekizumab 320 mg or secukinumab 300 mg during a 48-week double-blinded treatment period. They also included a 96-week open-label extension (OLE), resulting in 3 years of total treatment.

Overall, 373 patients were randomly assigned to receive bimekizumab and 370 to receive secukinumab. Among them, 336 patients initially assigned to receive bimekizumab and 318 patients initially assigned to receive secukinumab entered the OLE and received bimekizumab.

Among the patients entering the extension phase, the mean age was 45.5 years in the continuous bimekizumab group and 44.5 years in the secukinumab-to-bimekizumab group. Male patients accounted for 67.6% and 65.7% of the participants in these groups, respectively.

Patient-reported symptoms were assessed using the Psoriasis Symptoms and Impacts Measure, a 14-item patient-reported outcome instrument in which each item was scored on an 11-point numeric rating scale from 0 (no symptom or impact) to 10 (very severe symptom or impact). In this analysis, the researchers reported the proportion of patients with scores of 0 for itching, skin pain, and scaling.

At week 4, the proportion of patients reporting Psoriasis Symptoms and Impacts Measure scores of 0 differed between the treatment groups. Scores of 0 indicated an absence of the symptom. Among the patients receiving bimekizumab vs secukinumab, the rates were:

• No itching: 34% vs 25.1%

• No skin pain: 74.5% vs 60%

• No scaling: 46.1% vs 21.6%.

At year 1, the proportion of patients reporting Psoriasis Symptoms and Impacts Measure scores of 0 were:

• No itching: 60.9% vs 48.1%

• No skin pain: 78.6% vs 70.8%

• No scaling: 70.5% vs 49.7%.

Quality of life was assessed using the Dermatology Life Quality Index (DLQI), a 10-item instrument that evaluates the impact of skin disease on daily activities. Total scores range from 0 to 30, with scores of 0 or 1 indicating no effect of the disease on patients’ lives.

At week 4, DLQI scores of 0 or 1 were reported by 57.9% of the patients receiving bimekizumab and 410.8% of those receiving secukinumab. At year 1, these proportions were 77.7% and 70.3%, respectively.

The study also reported concurrent achievement of clinical and quality-of-life outcomes, including Psoriasis Area and Severity Index score (PASI) of 0 with DLQI score of 0 or 1.

Concurrent achievement of PASI score of 0 and DLQI score of 0 or 1 was reported in 11.5% of the patients receiving bimekizumab and 54.6% of those receiving secukinumab at week 4. At year 1, these proportions were 61.7% and 42.7%, respectively.

Patients randomly assigned to receive secukinumab switched to bimekizumab at year 1 on entry into the OLE. At year 3, concurrent achievement of PASI score of 0 and DLQI score of 0 or 1 was reported in 62.2% of continuous bimekizumab-treated patients and 63.8% of the patients who switched from secukinumab.

Among the patients entering the OLE, Psoriasis Symptoms and Impacts Measure scores of 0 for itching, skin pain, and scaling were reported through year 3.

At baseline, mean Psoriasis Symptoms and Impacts Measure scores were 6.6 and 6.8 for itching, 4.5 and 4.8 for skin pain, and 6.7 and 6.8 for scaling in the bimekizumab and secukinumab groups, respectively. Mean DLQI scores were 10.8 and 11.3.

Patient Global Assessment of Psoriasis responses of "no symptoms" were reported among 21.7% of the patients receiving bimekizumab and 12.4% of those receiving secukinumab at week 4. At year 1, these proportions were 61.4% and 43.2%, respectively.

The researchers used nonresponder imputation through 1 year and modified nonresponder imputation during the extension period. The patients discontinuing because of lack of efficacy or treatment-related adverse events were classified as nonresponders.

The researchers noted several strengths of the analysis, including the large sample size, low dropout rate, and 3-year follow-up. Outcomes were also evaluated in patients receiving a dosing regimen of bimekizumab every 4 weeks through week 16 followed by every 8 weeks thereafter, a schedule approved by regulatory agencies in most patients with plaque psoriasis.

However, the researchers reported limitations. Eligibility criteria may have limited the generalizability to patients seen in clinical practice, particularly those with comorbid conditions excluded from the trial. In addition, the OLE phase lacked treatment blinding, which may introduce bias in patient-reported outcomes.

“In this randomized clinical trial and OLE, bimekizumab rapidly and durably improved symptoms/health-related quality of life to 3 years,” wrote lead study author Matthias Augustin, MD, PhD, of the Institute for Health Services Research in Dermatology and Nursing at the University Medical Center Hamburg-Eppendorf in Germany, and colleagues.  

The research in this study was funded by UCB and supported by the National Institute for Health and Care Research Manchester Biomedical Research Centre. Full disclosures of the study authors can be found in the study.

Source: JAMA Dermatology