Psoriasis Improvement with Certolizumab Pegol Persisted a Year Later

Credit: Adobe Stock/ Kwangmoozaa

Certolizumab pegol demonstrated consistent effectiveness over 1 year, improving skin psoriasis activity and health-related quality of life.¹

“CIMREAL is the largest multinational observational study that offers insights into the real-world effectiveness and safety of [certolizumab pegol] in treating moderate to severe PSO across eight European countries and Canada,” wrote investigators, led by Bernhard Korge, from Dermatology Practice Dr. Bernhard Korge in Düren, Germany. “Our study stands out for its high proportion of women (68.2%), which is notably higher than in other clinical and real-world studies with other biologic agents.”

A 2021 study saw that psoriasis prevalence in the US is similar between men (2.8%) and women (3.2%).² Yet, as Korge and colleagues in the recent study explained, women with psoriasis experience lower disease activity but greater impairment of quality of life, lower biologic treatment satisfaction, and more adverse events than men.¹

Certolizumab pegol, an anti-tumor necrosis factor-alpha, is approved to treat moderate to severe plaque psoriasis. Despite the approval, real-world data is limited. Investigators sought to examine the effectiveness of certolizumab pegol after a year and its impact on health-related quality of life and safety outcomes in patients with moderate to severe psoriasis.

The team conducted CIMREAL, a prospective, noninterventional study, across Europe and Canada from August 2019 to December 2022. Participants received certolizumab pegol 400 mg at weeks 0, 2, and 4. Following that period, participants either received certolizumab pegol 200 mg every 2 weeks or certolizumab pegol 400 mg for maintenance dosing.

Investigators followed participants for 1-year and assessed the effectiveness of certolizumab pegol using the Psoriasis Area and Severity Index and the Dermatology Life Quality Index. They also evaluated safety.

The study included 399 patients with moderate to severe psoriasis; 77.9% completed 12 months. Participants had a mean age of 42.9 ± 13.5 years and a body mass index (BMI) of 28.5 ± 6.8 kg/m2. More than half of the sample was female (68.2%).

At 12 months, received certolizumab pegol exhibited effectiveness with PASI 75 and PASI 90 response rates of 77% and 56.5%—a ≥ 75% and ≥ 90% improvement from baseline—respectively. Participants with a PASI score of ≤ 3 and ≤ 2 experienced improvements from 3 months to 12 months (49.8% vs 82% and 41.1% vs 75.3%, respectively).

“…After 1 year of [certolizumab pegol] treatment, both sexes demonstrated similar rates of PASI 75 and PASI 90 responses,” investigators wrote. “These sex-based differences in participant distribution observed in CIMREAL have also been noted in real-world settings among [psoriasis] patients treated with [certolizumab pegol].”

Additionally, certolizumab pegol improved health-related quality of life and showed persistent improvement with certolizumab pegol. After 12 months of treatment, the Mean Dermatology Life Quality Index decreased from 12.4 to 2.3. The proportion of participants with a Mean Dermatology Index 0/1 increased from 28.6% at 3 months to 59.4% at 12 months.

Ultimately, the 1-year probability of persistence was approximately 85%. Certolizumab pegol demonstrated to be safe with only 30.6% experiencing adverse events and only 9.3% experiencing serious adverse events. The study did not identify any new safety concerns.

Investigators highlighted limitations, such as the lack of a control group, potential confounders not being examined, the follow-up period occurring during COVID-10 which limited the use of certolizumab pegol, and the study including a greater proportion of female females which could have been since certolizumab pegol is recommended during pregnancy.

“These results indicate that [certolizumab pegol] contributes to enhanced [psoriasis] outcomes in clinical settings considering clinical characteristics and patients’ preferences toward personalized management and treatment,” investigators concluded.

References

1. ^{Korge B, Vanhooteghem O, Lynde CW, et al. Certolizumab Pegol for the Treatment of Plaque Psoriasis in Routine Clinical Practice: One-Year Results from the CIMREAL Study. Dermatol Ther (Heidelb). Published online June 27, 2024. doi:10.1007/s13555-024-01210-3}
2. ^{Armstrong AW, Mehta MD, Schupp CW, Gondo GC, Bell SJ, Griffiths CEM. Psoriasis Prevalence in Adults in the United States. JAMA Dermatol. 2021;157(8):940–946. doi:10.1001/jamadermatol.2021.2007}