A new study tested that issue with results published in JAMA Dermatology. Radboud University Medical Center–led researchers note that biologics, which have revolutionized the treatment of psoriasis, are given in a fixed dose. The Dutch investigators questioned, however, whether lower doses might be possible.
To answer that question, the study team investigated whether dose reduction (DR) of biologics in patients with stable psoriasis is noninferior to usual care (UC).
This pragmatic, open-label, prospective, controlled, noninferiority randomized clinical trial was conducted from March 1, 2016, to July 22, 2018, at six dermatology departments in the Netherlands. Included in the study were 120 patients with plaque psoriasis and stable low disease activity who were receiving treatment with adalimumab, etanercept, or ustekinumab.
Patients were randomized 1:1 to dose reduction or usual care, with those in the DR group having injection intervals prolonged stepwise, leading to 67% and 50% of the original dose.
Defined as the primary outcome was between-group difference in disease activity corrected for baseline at 12 months compared with the predefined noninferiority margin of 0.5. Researchers also looked at secondary outcomes, including Psoriasis Area and Severity Index (PASI) score and health-related quality of life (including Dermatology Life Quality Index [DLQI] and Medical Outcomes Study 36-Item Short Form Health Survey scores); proportion of patients with short and persistent flares (defined as PASI and/or DLQI scores >5 for ≥3 months); and proportion of patients with successful dose tapering.
Of 120 patients (mean [SD] age, 54.0 [13.2] years; 82 [68%] male), 111 patients were included in the per-protocol analysis—53 in the DR group and 58 in the UC group.
Results indicate that 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). “This indicates that noninferiority was not demonstrated for DR compared to UC,” the authors write.
In addition, 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), indicating noninferiority for DR compared with UC, with no significant difference found regarding persistent flares between groups (five in both groups).
The authors note that 28 patients (53%; 95% CI, 39%-67%) in the DR group tapered their dose successfully at 12 months. No severe adverse events related to the intervention occurred, they add.
“In this trial, noninferiority was not demonstrated for DR of adalimumab, etanercept, and ustekinumab based on the PASI in patients with psoriasis compared with UC with the chosen noninferiority margin,” the researchers conclude. “However, the strategy was noninferior based on the DLQI. Dose tapering did not lead to persistent flares or safety issues.”
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