Biologic dose reduction fails to demonstrate noninferiority to usual care in psoriasis

A dose reduction schedule of biologics did not show noninferiority to the standard of care based on Psoriasis Area and Severity Index; however, quality of life scores did show noninferiority, according to a clinical trial.

The pragmatic, open-label, prospective, controlled, noninferiority randomized trial included 120 patients with plaque psoriasis at six Dutch dermatology centers. Patients received adalimumab, etanercept or ustekinumab treatment.

The subjects were randomly assigned 1:1 to receive their usual care or a prolonged injection interval, which led to 67% or 50% of the original dose.

The final analysis included 111 patients, with 53 in the dose reduction (DR) group and 58 in the usual care (UC) group.

Median PASI scores after 12 months of treatment were 3.4 in the DR group and 2.1 in the UC group. Corrected for baseline score, the mean difference in PASI score was 1.2 at month 12, which exceeded the noninferiority margin by 0.5, according to the study.

Subjects also filled out Dermatology Life Quality Index assessments during the trial. The median DLQI score for the DR group was 1.0, with the UC group showing a median score of 0.0 The mean difference, corrected for baseline DLQI, was 0.8, which indicated noninferiority because it did not cross the margin of 2.0.

“Noninferiority could not be demonstrated for the primary endpoint,” the study authors wrote. “This finding means that physicians and patients need to be aware of the chance of an increase in PASI score when trying to reduce the dose. It is important to weigh the risk of a PASI score increase against the benefits of using a lower dose of the biologic.”

Twenty-eight patients successfully tapered their dose after 12 months. The DR group had a mean cumulative dose 34% lower than UC for adalimumab, 26% lower for etanercept, 23% lower for 45 mg of ustekinumab and 34% lower for 90 mg of ustekinumab.

“Many patients were able to prolong the interval of their biologic use while maintaining low PASI and DLQI scores,” the authors wrote. “No difference regarding persistent flares was found in either group. This disease activity-guided DR strategy is expected to have an effect on health care expenditures.” – by Rebecca L. Forand

Disclosures: Atalay reports receiving grants from the Netherlands Organisation for Health Research and Development during the study and participating in trials sponsored by Janssen Pharmaceuticals, AbbVie, Celgene and Novartis. Please see the study for all other authors’ relevant financial disclosures.