In a study examining dose reduction (DR) strategy for adalimumab, etanercept, and ustekinumab in patients with psoriasis, noninferiority of DR compared with standard dose was not demonstrated for psoriasis area and severity index (PASI) scores at 12 months. However, many patients were able to prolong the interval of their biologic agent use while maintaining low PASI and dermatology life quality index (DLQI) scores. These study results were published in JAMA Dermatology.
The high financial burden and risk for long-term immunosuppressive effects associated with the use of biologic agents to treat psoriasis propelled researchers to investigate whether a disease activity-guided DR strategy of biologic agents in patients with psoriasis is noninferior to usual care (UC).
An open-label, prospective, controlled noninferiority randomized clinical trial of adalimumab, etanercept, and ustekinumab was conducted from March 2016 to July 2018 at 6 facilities in the Netherlands. In total, 120 patients (mean age, 54.0 [standard deviation, 13.2] years; 68% men) were randomly assigned to DR or UC schedules. Injection intervals were prolonged stepwise in the DR group, resulting in dose taperings of 67% and 50% of the original dose. Between-group difference in disease activity (PASI) corrected for baseline PASI at 12 months compared with the noninferiority margin was the primary outcome. PASI score and health-related quality of life, percentage of patients with short and persistent flares, and percentage of patients with successful dose tapering were the secondary outcomes.
Noninferiority was not demonstrated for DR compared with UC; the median PASI scores at month 12 were 3.4 (interquartile range [IQR], 2.2-4.5) in the DR group and 2.1 (IQR, 0.6-3.6) in the UC group (mean difference, 1.2; 95% CI, 0.7-1.8). For DLQI, noninferiority could be demonstrated; the median DLQI score at month 12 was 1.0 (IQR, 0.0-2.0) in the DR group and 0.0 (IQR, 0.0-2.0) in the UC group (mean difference, 0.8; 95% CI, 0.3-1.3). Dose tapering did not lead to more persistent flares, it was noted. No severe adverse events related to the intervention occurred.
Limitations of the study included the open-label study design, that relative PASI or Psoriasis Global Assessment score was not used, that the study was underpowered for per drug conclusions, and that there was an absence of a validated flare criterion for psoriasis.
The researchers concluded that “[DR] in real-life situations is possible, but a tight control scheme that monitors the [PASI] and [DLQI] is warranted.”
Atalay S, van den Reek JMPA, den Broeder AA, et al. Comparison of tightly controlled dose reduction of biologics with usual care for patients with psoriasis [published online February 12, 2020]. JAMA Dermatol. doi:10.1001/jamadermatol.2019.4897