Phase I Study to Assess Safety of Laser-Assisted Topical Administration of an Anti-TNF Biologic in Patients With Chronic Plaque-Type Psoriasis

Martin Bauer; Edith Lackner; Peter Matzneller; Valentin Al Jalali; Sahra Pajenda; Vincent Ling; Christof Böhler; Werner Braun; Reinhard Braun; Maximilian Boesch; Patrick M Brunner; Markus Zeitlinger

doi:10.3389/fmed.2021.712511

Phase I Study to Assess Safety of Laser-Assisted Topical Administration of an Anti-TNF Biologic in Patients With Chronic Plaque-Type Psoriasis

Front Med (Lausanne). 2021 Jul 16:8:712511. doi: 10.3389/fmed.2021.712511. eCollection 2021.

Affiliations

¹ Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
² Takeda - Pharmaceutical Sciences, Materials and Innovation, Cambridge, MA, United States.
³ Boehler Life Science Advice, Berneck, Switzerland.
⁴ Pantec Biosolutions AG, Ruggell, Liechtenstein.
⁵ Department of Dermatology, Medical University of Vienna, Vienna, Austria.

Abstract

Ablative fractional laser treatment facilitates epidermal drug delivery, which might be an interesting option to increase the topical efficacy of biological drugs in a variety of dermatological diseases. This work aims at investigating safety and tolerability of this new treatment approach in patients with plaque-type psoriasis. Eight patients with plaque-type psoriasis were enrolled in this study. All patients received (i) ablative fractional laser microporation (AFL) of a psoriatic lesion with an Er:YAG laser + etanercept (ETA; Enbrel® solution for injection) (AFL-ETA), (ii) ETA alone on another lesion, and, if feasible, (iii) AFL alone on an additional lesion. Overall, all treatment arms showed a favorable safety profile. AFL-ETA improved the lesion-specific TPSS score by 1.75 vs. baseline, whereas ETA or AFL alone showed a TPSS score improvement of 0.75 points, a difference that was not statistically significant and might be attributable to differences in baseline scores. Topical administration of ETA to psoriatic plaques via AFL-generated micropores was generally well-tolerated. No special precautions seem necessary in future studies. Clinical benefit will need assessment in sufficiently powered follow-up studies.

Keywords: biologic active molecule; drug delivery; etanercept (enbrel); laser; local tolerability; phase 1 clinical studies; plaque-type psoriasis; topical.