Efficacy outcomes
Mometasone significantly (p=0.0031) reduced the incidence of
induration/swelling at 0.5hours post-elamipretide (Table 2). There were
trends to significance in reduction of induration/swelling at 1-hour
post-dose (p=0.0736) and pruritus at 0.5 hours post-dose (p=0.0573) with
mometasone (Tables 2 and 3). Diphenhydramine significantly (p=0.0198)
decreased the incidence of induration/swelling at 1-hour
post-elamipretide dose, trending to significance (p=0.0698) in reduction
of induration/swelling at 0.5 hours post-dose (Table 2). For
subject-reported assessment of ISR signs/symptoms, ice application
significantly (p=0.0325) reduced the incidence of pain at 0.5 hours
post-elamipretide dose (Table 4) and trended to significance (p=0.0573)
for reduction of itching at 0.5 hours post-elamipretide dosing (Table
5).Mometasone trended to significant reductions swelling incidence at 1
hour post-elamipretide dose (p=0.3698), bothersome itching at 1 hour
post-dose (p=0.1409), and increased redness at 12 hours post-dose
(p=0867): the latter attributed to an occlusive dressing reaction.
Tacrolimus and doxepin demonstrated no significant differences in ISR
signs/symptoms compared to elamipretide administered alone in all
clinical and self-assessments.
Injection site photographs aligned with the signs/symptoms of ISRs
commonly described following SC administration of elamipretide.
Photographs supported the clinical assessments of ISRs conducted at the
same timepoints. Overall, photograph-captured ISRs were resolving at 4
hours post-elamipretide dose (exception of bruising which appeared to
form after the 12-hour post-dose timepoint in those affected). In the
mometasone arm, photographs aided in deciphering erythema grading in
subjects where the pattern of redness appeared to be related to the use
of the occlusive dressing and not the injection.