Researchers addressed the difference between prescribing guselkumab doses every 16 weeks and every 8 weeks for super responder patients with moderate to severe psoriasis.
With current psoriasis treatment guidelines lacking in benefits and providing inconsistent de-escalation advice, extending guselkumab dosing intervals for patients with moderate to severe psoriasis can help with disease stabilization. Results from the ongoing GUIDE phase 3b clinical trial showed that extending guselkumab dosing intervals from 8 to 16 weeks is a noninferior treatment option compared with currently accepted methods.
“Psoriasis is a chronic, systemic immune-mediated disease predominately characterized by skin plaques. Owing to the chronic and often progressive nature of the disease, long-term treatment is required, and the timing of targeted intervention plays a crucial role in the ensuing response to therapy. Though treatment de-escalation of biologic therapies for psoriasis is commonly applied in daily practice, evidence-based treatment guidelines and algorithms are lacking,” wrote authors of a study published in JAMA Dermatology.1
Guselkumab is a monoclonal antibody approved for the treatment of moderate to severe psoriasis as well as psoriatic arthritis, with 100 mg maintenance doses commonly administered every 8 weeks after 2 initial doses 4 weeks apart. The key variable in the GUIDE clinical trial is the fact that participants are considered super responders (SRes) due to the fact that they achieved early and complete skin clearance after using guselkumab.
Observing responses to guselkumab in a SRes population, researchers hypothesized that de-escalation of patients’ therapies could be just as effective if dosing intervals are extended from 8 weeks to 16 weeks. Using the Psoriasis Area and Severity Index (PASI), researchers’ clinical endpoint was for patients to exhibit noninferiority at week 68 of the trial with PASI scores lower than 3 and dosing intervals of every 16 weeks.
Researchers hypothesized that de-escalation of patients’ therapies could be just as effective if dosing intervals are extended from 8 weeks to 16 weeks. | image credit: RFBSIP / stock.adobe.com
Gathering both SRes and non-SRes patients with psoriasis, researchers separated 822 patients total into 2 groups: the first group receiving guselkumab at weeks 28, 36, 44, 52, and 60; while the other group received guselkumab at weeks 36 and 52. Regarding the patient population, 36.1% of patients were SRes (mean age, 39.4; 68% men). Among the 297 total SRes patients, 148 were randomized to guselkumab dosing every 8 weeks while the other 149 SRes patients received dosing every 16 weeks.1
The primary endpoint of noninferiority was met for both SRes patient groups as more than 90% of both cohorts achieved PASI levels below 3 after 68 weeks of follow-up. For SRes patients in the 16-week group, 137 of 149 patients (91.9%) had PASI scores below 3. The same number of patients within the 8-week interval group achieved PASI scores below 3, representing 92.6% of SRes patients within that group.
“Overall, a high proportion of SRes maintained PASI lower than 3 over time, independent of the treatment interval,” wrote the authors.1
While the results show 16-week intervals as noninferior to 8-week intervals, researchers concluded that the 8-week group achieved slightly better outcomes, with more than 80% maintaining completely clear skin compared with 70% in the 16-week group. However, data collected in the GUIDE clinical trial supply concrete evidence that prescription de-escalation for patients using guselkumab to treat psoriasis is possible at 16-week dosing intervals.
Also, findings from the GUIDE trial strengthen previous literature regarding guselkumab dosing and the tapering of biologic therapy within psoriasis management. Indeed, previous researchers attempted to understand the extension of dosing intervals for secukinumab—another biologic therapy similar to guselkumab—to treat patients with psoriasis in the OPTIMISE phase 3b trial. In this study, extending doses from every 4 to 6 weeks was unsuccessful, pushing researchers to suggest 4-week dosing intervals as the optimal regimen.2
“Data from the GUIDE trial add new insights into the concepts of disease modification and long-term maintenance of efficacy. Future analyses from the GUIDE trial will assess the association between clinical response and biomarker and pharmacokinetic data, and further evaluate maintenance of long-term response after treatment withdrawal,” concluded the authors.1
READ MORE: Biologics Offer Great Results in Treating Psoriasis—At a Cost
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