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Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository corticotropin injection (Acthar® Gel) for refractory severe noninfectious keratitis: efficacy and safety from a phase 4, multicenter, open-label study. Ophthalmol Ther. 2021;10(4):1077-1092.
Disclosure statement: Funding to support this study was provided by Mallinckrodt Pharmaceuticals. The authors of this study have financial and/or employment relationships with Mallinckrodt Pharmaceuticals.
*A target sample size of 36 patients was determined empirically. All 36 patients were included in the safety group. Efficacy endpoints were analyzed in the modified intent-to-treat (mITT) population (n=35), defined as all patients who received at least one dose of Acthar Gel and who contributed any post-baseline efficacy data to the study.
*A target sample size of 36 patients was determined empirically. All 36 patients were included in the safety group. Efficacy endpoints were analyzed in the modified intent-to-treat (mITT) population (n=35), defined as all patients who received at least one dose of Acthar Gel and who contributed any post-baseline efficacy data to the study.
IDEEL=Impact of Dry Eye on Everyday Life.
Patient-reported outcomes
Ophthalmic assessments
†The VAS is a validated patient-reported outcomes measure. The VAS in this study assesses various characteristic symptoms of dry eye disease.3
Patients had severe keratitis with tough-to-treat disease and high disease activity following prior treatment
LASIK=laser-assisted in situ keratomileusis.
Patient demographics and baseline characteristics
Patients had keratitis in both eyes and experienced symptoms for 4.4 years (mean)§ prior to treatment with Acthar Gel.
SD=standard deviation.
‡Data based on 35 patients in the mITT population.
§SD=5.4.
The IDEEL Questionnaire assesses the burden of dry eye disease and was developed to meet the FDA patient-reported outcomes guidance4,5
In a previous study, IDEEL-symptom bother baseline scores were classified as mild: 40.0 (SD=7.5), moderate: 50.6 (SD=11.0), and severe: 64.3 (SD=8.0).6
IDEEL=Impact of Dry Eye on Everyday Life; SD=standard deviation.
†Data related to the IDEEL-symptom bother score were reported for 34 patients.
Mean change from baseline in the IDEEL-symptom bother score1
MCID=minimal clinically important difference.
†Data related to the IDEEL-symptom bother score were reported for 34 patients.
‡95% CI: 33.2%, 66.8%.
§95% CI: 27.4%, 60.8%.
||95% CI: 2.8%, 26.5%.
VAS=visual analog scale.
NOTE: Confidence intervals only apply to observed numerical values for each assessment. They do not apply to percentage changes in improvement.
¶95% CI: -1.5%, -0.4%.
#95% CI: -0.9%, -0.2%.
**95% CI: -0.4%, 0.1%.
††95% CI: 0.4%, 3.9%.
‡‡Unanesthetized Schirmer's test to determine the amount of tears produced over 5 minutes.
§§95% CI: -1.6%, -0.6%.
||||95% CI: -1.2%, -0.2%.
¶¶95% CI: -0.6%, -0.1%.
##95% CI: -0.1%, 2.7%.
No clinically meaningful changes in visual acuity or slit-lamp examination were observed.
No new or worsening cataracts or clinically meaningful changes in intraocular pressure were observed.
TEAE=treatment-emergent adverse event.
†36 patients were enrolled and included in the safety population.
‡One serious TEAE of intentional overdose with fatal outcome was reported but was not related to Acthar Gel treatment.
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Acthar Gel is indicated for:
Contraindications
Acthar is contraindicated:
Warnings and Precautions
Adverse Reactions
Pregnancy
Please see full Prescribing Information for additional Important Safety Information.
Acthar Gel is indicated for:
Acthar Gel is indicated for:
Contraindications
Acthar is contraindicated:
Warnings and Precautions
Adverse Reactions
Pregnancy
Please see full Prescribing Information for additional Important Safety Information.
Acthar Gel is indicated for:
Contraindications
Acthar is contraindicated:
Warnings and Precautions
Adverse Reactions
Pregnancy
Please see full Prescribing Information for additional Important Safety Information.
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