Documentdetail
ID kaart

doi:10.1007/s40123-022-00501-2...

Auteur
Toyos, Melissa Toyos, Rolando Jodoin, Barbara Bunch, Ryan
Langue
en
Editor

Springer

Categorie

Medicine & Public Health

Jaar

2022

vermelding datum

05-07-2022

Trefwoorden
acthar gel clinical trial ded ocular inflammation rci lesions dry eye moderate staining spk scores ded = 0 study rci
Metriek

Beschrijving

Introduction There is a substantial unmet need for effective therapies to treat patients with refractory dry eye disease (DED).

The goal of this open-label pilot study was to investigate the efficacy and safety of repository corticotropin injection (RCI; Acthar® Gel; Mallinckrodt Pharmaceuticals) in subjects with DED, most of whom did not experience adequate response to standard-of-care therapies.

Methods Adults with moderate or severe-acute DED received 80 U of subcutaneous RCI twice weekly for 12 weeks.

Primary efficacy outcomes were improvements in corneal fluorescein staining of superficial punctate keratitis (SPK) lesions and Symptom Assessment in Dry Eye (SANDE) scores.

Secondary outcomes included changes in Schirmer’s test scores, conjunctival lissamine green staining, erythema, intraocular pressure (IOP), and best corrected visual acuity (BCVA).

Adverse events (AEs) were assessed continuously throughout the study.

Results Fifteen subjects received at least 1 dose of RCI, and 12 subjects completed the study.

Compared to baseline (day 1), significantly fewer fluorescein-stained SPK lesions were detected at day 14 ( p  = 0.0250) and day 84 ( p  = 0.0240) after RCI treatment.

Mean SANDE scores progressively declined from 62.0 at baseline to 46.9 at day 84.

Erythema ( p  = 0.0046), conjunctival lissamine green staining of SPK lesions ( p  = 0.0317), and IOP ( p  = 0.0052) were all significantly improved after 12 weeks of RCI therapy.

Schirmer’s test scores and BCVA showed no significant changes throughout the study.

No ocular AEs or deaths occurred, and no new safety signals were identified for RCI.

Conclusions These results suggest that RCI may be a safe and effective treatment for moderate and severe DED.

Trial registration ClinicalTrials.gov identifier: NCT03287635.

Toyos, Melissa,Toyos, Rolando,Jodoin, Barbara,Bunch, Ryan, 2022, Results from a Prospective, Open-Label, Phase 4 Pilot Study of Repository Corticotropin Injection for Moderate and Severe Dry Eye Disease, Springer

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