Artificial daylight photodynamic therapy using methyl aminolaevulinate in a real-world setting in Germany: results from the noninterventional study ArtLight.

BACKGROUND

Artificial daylight photodynamic therapy (ADL-PDT) is an alternative, all-year applicable, nearly painless treatment approach for actinic keratosis (AK) with comparable effectiveness to daylight or conventional PDT. At the time this study was initiated, methyl aminolaevulinate (MAL) was the only photosensitizer approved for ADL-PDT in Germany.

OBJECTIVES

To gain comprehensive insights into the practicability of MAL-ADL-PDT in patients with AK using different artificial daylight sources under real-world conditions.

METHODS

This prospective, noninterventional, multicentre study (ArtLight, NCT05725213) enrolled patients with Olsen grade 1 or 2 AK on the face and scalp in Germany. Patients were treated with MAL-ADL-PDT (160 mg g-1 MAL cream). The primary outcome measure was the practicability of MAL-ADL-PDT assessed as rate of resolved AK lesions in the focus area (10 × 10-cm area within the treatment area). Secondary outcomes included treatment-associated pain (numeric rating scale, NRS), Actinic Keratosis Area and Severity Index (AKASI), total lesion count over time, skin preparation, safety, overall assessment of effectiveness, tolerability, adherence and patient satisfaction.

RESULTS

In total, 224 patients [median age 75.0 (range 50-91) years, 85.3% male, 62.5% AK Olsen grade 2, 55.4% treatment-naïve] were included and treated with MAL-ADL-PDT. Three months after treatment, lesion counts were reduced in the focus area by 71% (P < 0.001) indicating practicability of the treatment. Nearly all patients (93.3%) experienced no or mild pain during PDT (NRS score 0-3). Median AKASI decreased from 6.2 at baseline to 3.4 at month 3 (95% confidence interval 2.4-3.0; P < 0.001). The majority of investigators (82.8%) and patients (80.0%) were satisfied with the treatment. No new safety signals were reported.

CONCLUSIONS

The clinical practicability of MAL-ADL-PDT was demonstrated under real-world conditions by effective lesion reduction and predominantly none-to-mild procedural pain. Thus, MAL-ADL-PDT is a convenient way for healthcare professionals to deliver PDT treatment to patients with AK located on the face and scalp.