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The January 2023 rheumatology month in review highlights a recent study that indicated an increased risk of hospitalization and death among patients with gout and COVID-19, the expansion of research evaluating adalimumab biosimilars, and trends in fibromyalgia.
The last week of each month, our editorial team compiles a list of our most popular rheumatology content from the past month for a month in review recap. The January 2023 rheumatology month in review highlights a recent study that observed an increased risk of hospitalization and death among patients with gout and COVID-19, the expansion of research evaluating adalimumab biosimilars, and trends in fibromyalgia.
The interest in and incentive to develop biosimilars has been increasing in the United States in recent years. Biosimilars are similar to their bio-originators in immunogenic, pharmacokinetic, safety, and efficacy profiles. Additionally, the availability of biosimilars can afford patients with more access to treatment and decrease medication-related costs. However, as one study reported, patients with rheumatoid arthritis (RA) switching to a biosimilar for a non-medical reason led to worse outcomes. Therefore, the decision to switch to a biosimilar should be carefully considered.
Patients with Rheumatoid Arthritis Satisfied with Switch to Adalimumab Biosimilar
A hospital-wide switch from adalimumab to an adalimumab biosimilar inspired investigators to conduct the single-center, retrospective, observational study which evaluated any changes in disease activity, functional disability, and quality of life in patients with rheumatoid arthritis starting treatment with a biosimilar.
Results showed that disease activity did not significantly increase from baseline measurements and those taken at 3 months. Similar results were seen at the 6-, 9-, and 12-month evaluations. Additionally, patient-reported outcomes did not significantly change from prior to the initiation of the biosimilar.
Research included in the study was drawn from a questionnaire given to clinicians regarding their next 10 adult RA patients and then followed by 4 additional patients. Those switching to adalimumab biosimilars from the bio-originator were placed in the “switchers” category.
The study’s results indicated overall better outcomes for non-switcher RA patients compared with those who were switchers, with data indicating non-switchers were more likely over those who switched to improve on their ongoing adalimumab therapies. The switcher cohort was also found to be less consistent with their treatment.
Biosimilar Adalimumab-aacf Gains FDA Approval, Marks Growing Interest in Biosimilar Development
The FDA approved the biosimilar adalimumab-aacf (Idacio), a citrate-free formulation of adalimumab in December 2022. The tumor necrosis factor (TNF) inhibitor is set to launch commercially in the US in a self-administered prefilled syringe and a self-administered pre-filled pen in July 2023.
In an interview with HCPLive, Brandee Pappalardo, PhD, Senior Vice President and Chief Medical Officer, US Medical Affairs, at Fresenius Kabi, spoke about what the approval means for the future of treatment for patients with rheumatic diseases and the clinicians tasked with choosing the right drug.
Increased Risk of Hospitalization, Death Observed in Patients with Gout and COVID-19
Investigators used data from the COVID-19 Global Rheumatology Alliance (C19-GRA) provider registry to analyze COVID-19 outcomes for people with rheumatic and musculoskeletal diseases living in Ireland. The differences in the likelihood of hospitalization and mortality according to clinical and demographic variables were determined.
The risk of hospitalization and death was elevated in patients with gout, older patients, those with comorbidities, a history of smoking or long-term glucocorticoid use, and those with cardiovascular or pulmonary disease. Mortality risk increased in obese patients and hospitalization increased in patients with cancer.
This month’s fibromyalgia research involved the disabling symptoms, both mental and physical, that often plague this patient population. The first, highlights the relationship between physical function and distress in patients currently experiencing pain. The second, evaluates the reliability of the 3-Meter Backward Walk Test (3MBWT) tool for screening patients’ balance and determining the probability of falls.
Distress Negatively Impacts Functionality of Patients with Fibromyalgia Experiencing Pain
Two overarching hypotheses were made in the cross-sectional study, with the first being that the mediating variable (distress) would help to understand the relationship between pain intensity and activities of daily living (ADLs) in this patient population, even after controlling for age, gender, and income. The second was that distress would help to understand pain interference and ADLs after controlling for age.
Investigators enrolled patients with fibromyalgia at the Fibromyalgia and Chronic Pain Center, at California State University, Fullerton. Pain intensity, pain interference, depression, and anxiety were measured. Distress was determined using depression scores and anxiety scores.
New Study Supports 3-Meter Backward Walk Test Tool for Fibromyalgia
A common debilitating symptom of patients with fibromyalgia (experienced by almost half of patients) is impaired balance. More specifically, patients often report nonspecific postural balance disorder, reduced mobility performance, as well as increased risk and occurrence of falls.
The Time Up and Go (TUG) test was used to screen patients' balance and probability of falls, which was also accounted for in the 3-Meter Backward Walk Test (3MBWT) as it evaluated neuromuscular control, proproception, and protective reflexes.
Data showed the 3MBWT can be considered reliable under single and dual-task conditions when measured simultaneously with a manual stopwatch and a Chronopic automatic stopwatch.