Study Supports Rabies Immunoglobulin for Post-Exposure Prophylaxis in Kids

NEW YORK (Reuters Health) – In children with confirmed or suspected rabies, human rabies immunoglobulin (HRIG) appears to be an effective part of the post-exposure prophylactic (PEP) treatment, researchers say.

“We know the incidence of kids being exposed to animals that may transmit rabies is high,” Dr. Novinyo Amega of Kedrion Biopharma, in Fort Lee, New Jersey, told Reuters Health by email. “However, little data exist that can help clinicians better understand the safety profiles of the various HRIG products currently available.”

Dr. Amega and colleagues conducted a phase-4 prospective, single-arm clinical trial of KEDRAB, an HRIG distributed by Kedrion Biopharma and approved by the U.S. Food and Drug Administration (FDA) in 2017, in 30 patients under 17.

All participants had confirmed or suspected rabies exposure in which PEP was indicated. This included standard-of-care wound washing, passive immunization with HRIG, and induction of active immunity through initiation of the rabies vaccine series. No placebo group was used, as this would have been ethically unacceptable due to the high fatality rate of rabies, the researchers say.

Participants received 20 IU/kg of HRIG150 (150 IU/mL) infiltrated into the wound site or sites. Any remainder was injected intramuscularly, concomitantly with the first of a four-dose series of rabies vaccine. Rabies virus neutralizing antibody (RVNA) titers and tolerability were assessed on day 14 following administration of the last vaccine dose.

There were no serious adverse events, rabies infections, or deaths, the researchers report in Human Vaccines and Immunotherapeutics. Twelve participants experienced a total of 13 adverse events deemed related to the study treatment, but all were mild.

By day 14, RVNA levels had reached at least 0.5 IU/mL in all but two of the participants. However, say the investigators, testing was “not repeated subsequently; thus, it remains possible that the two subjects that did not attain the cutoff by day 14 seroconverted by day 30.”

The study results have been submitted to the FDA for review, Dr. Amega said, adding, “we are pleased to see that top-line results of this pediatric study support KEDRAB’s safety profile. Importantly, we believe that meeting the primary objective of this study could further differentiate KEDRAB from other currently available HRIGs in the U.S.”

Kamada Ltd, which manufactures KEDRAB, and Kedrion Biopharma funded the study. Most of the authors are employees of these companies.

SOURCE: https://bit.ly/3u3cvhH Human Vaccines and Immunotherapeutics, online February 9, 2021.

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Ergonomic Consultation Spares Endoscopists a Pain in the Neck

Assessment of position and posture by a physical therapist can help reduce and prevent injury in endoscopists, based on data from a pilot study of eight individuals.

Musculoskeletal injuries among endoscopists are gaining more attention: One technical review indicated that the “prevalence of musculoskeletal pain or injuries ranged from 29% to 89% of gastroenterologists.” While data on avoiding musculoskeletal injury related to endoscopy are limited, recognition of the role of ergonomics is increasing, Stacy A. Markwell, a physical therapist in Chapel Hill, N.C., and colleagues, wrote in a study published in Gastrointestinal Endoscopy.

The mental concentration required along with the physical demands on manipulating the scope have been shown to negatively impact posture, the researchers noted.

The researchers reviewed data from eight endoscopists who were aged 32-71 years; they had a range of clinical experience and were performing 6-30 colonoscopies and 3-21 upper endoscopies per week.

These endoscopists volunteered for an ergonomic intervention involving use of an individualized wellness plan. They completed the Nordic Musculoskeletal Questionnaire to evaluate musculoskeletal complaints during the past 12 months and the past 7 days. Three of the eight participants reported pain at work at initial assessment, which often worsened over the course of the day, and five mentioned fatigue while working. They specified 22 pain sites, mainly in the neck and back. In addition, participants were photographed to evaluate posture in a static position and self-selected “tired” positions.

“When frequent or consistent posturing resulted in suboptimal joint alignment, muscle length, loading at end range of muscle or joints, and/or prolonged static active positioning, participants were photographed to provide personalized feedback for wellness education,” the researchers wrote.

The physical therapist used information from the evaluation and photographs to develop individual plans to improve the ergonomics of the endoscopic suite with adjustments to the location of the bed and positioning of chairs, standing surfaces, and monitors and keyboards. In addition to adjusting the endoscopic suite, the physical therapist developed individual wellness plans including exercises to relieve pain and improve posture, as well as pain education to help clinicians recognize and manage pain and fatigue.

By the end of the study, in a follow-up 6-12 months after the wellness intervention, 63% of pain sites (14 of 22) reported by participants were reduced in intensity or resolved, 32% were unchanged (7 of 22), and 4% increased (1 of 22).

Overall, seven of the eight participants said that the pictures of their posture along with the movement analysis was helpful, and three participants asked for reassessment by the physical therapist. In this study, the average cost of the wellness program was $500.

“All endoscopists reported that the wellness plan was helpful, with procedure suite and posture recommendations being the most beneficial,” the researchers reported. “Upon gaining insight with visualization of their posture and movement during endoscopy, participants’ understanding and motivation to make corrections was intensified.”

The study findings were limited by several factors including the small size, use of a single physical therapist, short follow-up, lack of controls, and use of a single site, the researchers noted. However, “our study provides a detailed, pragmatic, and reproducible framework for performing an individualized physical therapist–directed comprehensive assessment and personalized wellness plan in the workplace to help meet the challenges of ergonomics in endoscopy.”

Recognition of the Value of Ergonomics Is Rising

“Endoscopy related injury and disability is a known hazard of our profession,” said Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, in an interview. “Any studies to assess and, more importantly, offer ways to prevent such injury are immediately relevant. In this context, ergonomics for endoscopy is an increasing area of research.”

Ketwaroo said that the study results were not surprising. “I agree with authors that there is a paucity of general ergonomic training and assessment. Specific individualized wellness plans are rare. Developing an individual plan based on observation by physical therapists, and taking into account baseline injury or predisposition to injury would be expected to be more high yield for preventing injury and improving performance

“I believe the main take-home message from the study is that an individualized ergonomic plan based on assessment and feedback by physical therapists appears promising for optimizing endoscopic performance to minimize injury and reduce fatigue,” Ketwaroo said. However, “long-term studies in much larger samples will be needed to document objective findings of reduced injury or fatigue.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Ketwaroo serves on the GI & Hepatology News editorial advisory board.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.

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