Ankle replacement and fusion demonstrate similar effectiveness for end-stage ankle osteoarthritis

1. Ankle replacement and fusion demonstrate similar effectiveness for end-stage ankle osteoarthritis
Abstract: https://www.acpjournals.org/doi/10.7326/M22-2058
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A study of persons with end-stage ankle osteoarthritis found that both total ankle replacement (TAR) and ankle fusion (AF) improve patients quality of life and have similar clinical scores and risks after surgery. TAR was associated with a greater wound-healing complications and nerve injuries, while AF was associated with more blood clots and nonunion of the ankle bones. The findings are published in Annals of Internal Medicine.

Ankle osteoarthritis causes severe pain and disability. Persons with ankle osteoarthritis are primarily treated with nonoperative treatment, including weight loss, activity modification, support braces, and analgesia. However, surgical interventions may be used if non-surgical treatments are unsuccessful. The main surgical options are TAR and AF. TAR replaces the ankle joint and retains movement, while AF fuses the ankle bones together so there is no motion. It may be difficult for patients and clinicians to decide which intervention is more appropriate because of a lack of high-quality data to inform decision-making.

Researchers from University College London & Imperial College London conducted a randomized controlled trial of 303 persons with end-stage ankle osteoarthritis, aged 50 to 85 years, who the treating surgeon believed to be suitable for either ankle replacement or ankle fusion. After patients underwent operation, the authors calculated the clinical response by measuring the walking and standing domains of the Manchester–Oxford Foot Questionnaire at both preoperation and 52 weeks postoperation for each group. They found that both walking and standing domain scores improved by similar rates at 52 weeks for both groups. However, in a retrospective analysis they showed that the commonest ankle implant used in the UK, a fixed bearing, or two component ankle, in fact did show better outcomes than ankle fusion at 52 weeks. The investigators also report that each group experienced similar rates of adverse events, but TAR was associated with greater wound-healing complications and nerve injuries while AF was associated with more blood clots and nonunion of the ankle bones.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with one of the authors Andy Goldberg, email andrew.goldberg@ucl.ac.uk.
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2. Monoclonal antibody treatment safe for pregnant persons with mild to moderate COVID-19
Abstract: https://www.acpjournals.org/doi/10.7326/M22-1329
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A cohort study of more than 900 pregnant persons has found that monoclonal antibody (mAb) treatment for mild to moderate COVID-19 is safe for clinical use. Reported adverse effects were also rare and mild. The study is published in Annals of Internal Medicine.

mAb treatment is associated with decreased hospitalization and death in outpatients with mild to moderate COVID-19. Pregnancy is currently considered a risk factor for severe disease, and guidelines recommend the use of mAb for treatment of pregnant persons with COVID-19. However, data on effectiveness and safety are limited.

Researchers from the University of Pittsburgh School of Medicine conducted a cohort study of 944 pregnant persons between April 2021 and January 2022. Of all participants, 58 percent received mAb treatment and 69 percent of those persons were given sotrovimab. The authors found that among treated persons, drug-related adverse events occurred in 1.4 percent of participants and there were no differences in any obstetric-associated outcome among 778 persons who delivered. They also report no difference in 28-day COVID-19–associated outcomes and non-COVID-19–related hospital admissions for mAb treatment compared with no mAb treatment. According to the authors, in the context of their study, pregnant persons with minimal comorbidities and low risk for severe disease in the Omicron variant era may not benefit from treatment with the routine use of mAbs. However, they note that it is unknown whether mAbs would benefit (or harm) pregnant persons with additional risk factors for severe disease, and whether different mAbs are variably effective against different SARS-CoV-2 variants in pregnant persons.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Erin K. McCreary, PharmD, please contact Allison Hydzik at hydzikam@upmc.edu.
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3. California’s insulin initiative offers path for other state drug manufacturing efforts
Abstract: https://www.acpjournals.org/doi/10.7326/M22-2339
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In a new ‘Ideas and Opinions,’ authors from Johns Hopkins Bloomberg School of Public Health analyze California’s newly announced effort to manufacture insulin for its residents. The commentary is published in Annals of Internal Medicine.

As previously published in Annals, the current cost of insulin in America puts the health of persons with diabetes at risk. A survey published in the 18 October issue found that 1 in 5 Americans, particularly uninsured and privately insured persons, ration their insulin because of cost. In July 2022, the state of California announced it would begin a new initiative to create a state-led insulin manufacturing effort that would develop, manufacture, and distribute insulin at below-market prices.

In their commentary, the authors highlight how California’s insulin manufacturing initiative will disrupt the insulin market. First, it will provide insulin at transparent prices that are closer to the cost of production, providing financial relief to many of the 3 million Californians who have diabetes. The authors estimate that this initiative could save a single person with type 1 diabetes up to $2,000 to $4,000 per year if they switch to CalRx from cash prices. Second, California may create the beginning of a system that breaks from the current model where supply chain participants profit off rebates and price concessions negotiated for insurers; they will do this by partnering directly with health plans such as the California Public Employees' Retirement System (CalPERS) and Covered California to create a market for CalRx insulins. However, the authors advise that the success of the program depends on the number of beneficiaries will accept its products and ensuring that CalRx insulins are easily available and accessible to consumers by developing relationships with pharmacies and convenient retail outlets. According to the authors, success of the CalRx Biosimilar Insulin Initiative will lay the groundwork for future targets, such as other biologic and nonbiologic drugs.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author Mariana P. Socal, MD, PhD, please email msocal1@jhu.edu.
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