H. Pylori Infection Treatments

Yuto Shimamura, MD, from Showa University in Tokyo, and colleagues evaluated the feasibility, safety, and effectiveness of ARMA. The analysis included 68 patients with GERD symptoms refractory to acid suppression medications or those dependent on such medications.

The researchers found that clinical success rates (defined as >50% reduction in a validated GERD questionnaire) at 2 to 6 months and 1 year post-ARMA were 60 and 70%, respectively. There were significant improvements seen in the median GERD health-related quality of life score from 26 to 11 at two to six months. Among those who underwent 24-hour pH monitoring (51 patients), median acid exposure time significantly decreased from 5.3 to 0.7%, along with a significant reduction in esophagitis rates. No factors predicted short-term success in a multivariate analysis. Transient stenosis requiring balloon dilation was seen in nine patients (13.2%).

“Both reflux hypersensitivity and confirmed GERD patients, regardless of their response to acid suppression medication, may be suitable candidates,” the authors write.

Several authors disclosed ties to industry.

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Drug-Induced Photosensitivity

The approval was supported by data from the randomized, double-blind, placebo-controlled phase 3 EoE KIDS study (ClinicalTrials.gov Identifier: NCT04394351), which evaluated the efficacy and safety of dupilumab, an interleukin-4 receptor alpha antagonist, in patients 1 to 11 years of age with active EoE (Parts A and B). 

Eligible patients had 15 or more intraepithelial eosinophils per high-power field (eos/hpf) despite treatment with a proton pump inhibitor either prior to or during the screening period and a history of EoE signs and symptoms. The primary endpoint in Part A was histological disease remission, defined as the proportion of patients achieving peak esophageal intraepithelial eosinophil count 6 or less eos/hpf at week 16.

Findings showed 65.6% (21/32) of patients who received dupilumab at tiered dosing regimens based on weight (≥15 to <30kg: 200mg every 2 weeks; and ≥30 to <60kg: 300mg every 2 weeks) achieved histological disease remission at week 16 compared with 3.4% (1/29) of those who received placebo (difference, 62% [95% CI, 44-79.95]). 

Additionally, a greater decrease in the proportion of days with 1 or more signs of EoE (based on the Pediatric EoE Sign/Symptom Questionnaire-caregiver version) was observed for patients treated with dupilumab vs placebo at 16 weeks.

Part B of the study was an extended-active treatment period that included 47 patients who completed Part A. At week 52, histological remission was achieved in 17 of the 32 patients (53%) treated with dupilumab in Parts A and B and in 8 of the 15 children (53%) who switched to dupilumab from placebo in Part B.

The most common adverse events reported with dupilumab were injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.

“With this approval, Dupixent becomes the first and only treatment option for EoE patients aged 1 year and older, weighing at least 15 kg,” said George D. Yancopoulos, MD, PhD, Board co-chair, President and Chief Scientific Officer at Regeneron. “By targeting the underlying type 2 inflammation that contributes to this disease, Dupixent has the potential to transform the standard of care for these children as it has for adults and adolescents with EoE.”

For the current study, researchers analyzed results of the ELEVATE UC 52 trial (ClinicalTrials.gov Identifier: NCT03945188). Patients aged 16 to 80 years with moderately to severely active UC were randomly assigned 2:1 to receive once-daily etrasimod 2 mg or placebo for 12 weeks of an induction period followed by a 40-week maintenance period.

A significantly larger group of patients in the etrasimod arm experienced CS-free clinical remission (32.1% vs 6.7%; P <.001), CS-free endoscopic improvement (36.9% vs 10.4%; P <.001), and CS-free symptomatic remission (43.4% vs 18.5%; P <.001) at week 52

vs placebo.

The research team performed subgroup analyses of CS-free clinical remission and noted efficacy across subgroups, including previous exposure to a biologic/JAKi, number of previous biologics/JAKis (0, 1, or >1), disease severity at baseline (MMS 4-6 or 7-9), and extent of disease (proctitis, left-sided colitis/proctosigmoiditis, or pancolitis). Patients who were biologic/JAKi-naive benefited more than those who were exposed to 0 or 1 vs greater than 1 prior biologic/JAKi.

CS-free remission is defined as no CS exposure in the 12 weeks prior to week 52, clinical remission, CS-free endoscopic improvement, and CS-free symptomatic remission at week 52 in the study population, as well as CS-free clinical remission in prespecified subgroups.

“In ELEVATE UC 52, a greater proportion of etrasimod-treated subjects achieved CS-free clinical remission, CS-free endoscopic improvement, and CS-free symptomatic remission at week 52,” the study authors wrote.