Can Biologic Doses Be Lowered for Patients With Stable Disease?

The treatment of psoriasis was revolutionized with the advent of biologics. While biologics are usually administered in a fixed dose, it may be possible to lower this dose among patients with stable psoriasis, according to the results of a recent study.

Although the study did not demonstrate noninferiority for lowering biologic dose among patients with stable psoriasis compared with usual care in the selected noninferiority margin, this strategy was found to be noninferior based on quality of life assessments.

Furthermore, lowering biologic dose did not lead to persistent flares in the study population, suggesting that dose reduction may be an option for some patients with well-controlled plaque psoriasis.

In the open-label, prospective, controlled, randomized, noninferiority trial, the researchers investigated whether dose reduction of biologics was noninferior to usual care among 120 participants with stable plaque psoriasis and low disease activity. Participants treated with adalimumab (Humira), etanercept (Enbrel), or ustekinumab (Stelara) were randomly assigned to either dose reduction (n=60) or usual care (n=60). In the dose reduction group, the researchers prolonged the injection intervals using a stepwise approach, leading to 67% and 50% of the original dose.

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Primary and secondary outcomes included between-group difference in disease activity, corrected for baseline at 12 months compared with the predefined noninferiority margin of 0.05; Psoriasis Area and Severity Index (PASI) score; health-related quality of life, which was measured using the Dermatology Life Quality Index (DLQI) and Medical Outcomes Study 36-Item Short Form Health survey; the proportion of participants with short and persistent flares; and the proportion of participants with successful dose tapering.

Of the 120 participants, only 111 were included in the per-protocol analysis (dose response group n=53; usual care group n=58).

After 12 months, the median PASI scores were 3.4 in the dose reduction group and 2.1 in the usual care group (mean difference 1.2; 95% CI, 0.7-1.8). “This indicates that noninferiority was not demonstrated for dose response to usual care,” the researchers wrote. However, the median DLQI scores at 12 months showed noninferiority between the dose reduction group and usual care group (1 vs 0; mean difference 0.8; 95% CI, 0.3-1.3), the researchers noted.

In addition, the researchers found no significant differences between groups for persistent flares, with 5 participants in each group experiencing flares. They also found that 28 participants were able to successfully taper their dose (53%; 95% CI, 39% to 67%) after 12 months in the dose reduction group. No severe adverse events were reported, the researchers added.

“Dose reduction in real-life situations is possible, but a tight control scheme that monitors the PASI and DLQI is warranted,” the researchers concluded.

Reference

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: A randomized clinical trial [published online February 12, 2020]. JAMA Dermatol. doi:10.1001/jamadermatol.2019.4897