Protocolized Biologic Dose Reduction is Feasible for Patients With Psoriasis

A strategy to implement protocolized biologic dose reduction (DR) for patients with psoriasis is feasible and could be achieved with additional support staff, extra time during consultations, and education on DR for health care professionals (HCPs) and patients, according to study findings published in Journal of Dermatological Treatment.

Researchers conducted a pilot implementation study in 3 general hospitals in the Netherlands for 6 months during which HCPs adopted a protocolized DR of the biologics adalimumab, etanercept, and ustekinumab for patients with psoriasis.

Biologic DR focused on patients with stable, low-disease activity for at least 6 months who were treated with a standard dose for at least 6 months. The multicomponent implementation strategy involved education, feedback, and local protocol development. Assistance tools included protocols, summary cards, patient information leaflets, and standardized texts for managing DR procedures in patients’ electronic health records.

Inventory meetings occurred in April 2021 (hospitals 1 and 3) and May 2021 (hospital 2), and the 6-month intervention was initiated in June 2021 (hospital 2) and July 2021 (hospitals 1 and 3).

Participating hospitals received all components of the implementation strategy. After the first feedback meeting, hospital 1 had used all provided tools, hospital 2 only used the protocol, patient information leaflet, and administration text, and hospital 3 used the summary card and patient information leaflet. Therefore, fidelity was less than 100%.

The HCPs indicated the feasibility of implementing the DR protocol, with additional time for patient education and adjustment of prescriptions needed occasionally. In addition, adjustment of proposed protocols and dissemination at the local workplace also required time for the HCPs.

From January to April 2022, 10 HCPs participated in interviews. The HCPs stated that education, awareness, and familiarity could enhance adoption of the DR. According to the HCPs, enhanced knowledge could be achieved with scientific publications, conference presentations, and uptake of biologic DR in treatment guidelines.

Sufficient patient education and involvement of patients in decision-making also were suggested as facilitators by the HCPs. According to the HCPs, providing health care access during the DR and communication or tools about new dosing schedules was important for patients.

Patient education, modifying prescriptions, and determining scores on the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) required time and additional support to help overcome these barriers.

A total of 52 of 101 patients (51.5%) were eligible for DR during the intervention period, and 26 (50%) initiated DR. The proposed DR protocol was adhered to by 22 of the 26 patients (84.6%). More outcome measures such as PASI and DLQI were performed after the intervention than at baseline, although scores were not measured in all patients on DR.

Limitations of the study include the fact that the implementation strategy was tested in a specific, national setting and the intervention period was relatively short. Also, owing to the uncontrolled design, the researchers were unable to conclude which part of the strategy was most effective or define a causal relationship between the intervention and results.

Study authors conclude, “Results of our pilot study demonstrated feasibility of a strategy to implement protocolized biologic DR for patients with psoriasis in daily dermatological practice. Provision of protocols, patient information leaflets, and education for HCPs were important tools for implementation of DR, and led to an increase of patients that underwent protocolized DR of the biologics adalimumab, etanercept, or ustekinumab.”

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.