The edition · Rheumatology
Glass particles force a Class I recall of a tocilizumab biosimilar
Tyenne 400 mg vials are being recalled after glass was found in the product; and in 6,168 patients with non-renal lupus, the infection risk that looked like a drug effect turned out to track glucocorticoid dose.
The edition in brief
The FDA has posted an ongoing Class I recall of Tyenne (tocilizumab-aazg) injection, 400 mg per 20 mL vials made by Fresenius Kabi USA, after an internal investigation found glass particles in the product. Class I is the most serious category, meaning a reasonable probability of serious harm or death. Separately, a target trial emulation in 6,168 patients with non-renal systemic lupus erythematosus compared infection-related hospitalisation after starting azathioprine, belimumab, methotrexate or mycophenolic acid analogues. Two-year cumulative incidence was 13% for mycophenolic acid analogues, 10% for azathioprine and methotrexate, and 8% for belimumab; mycophenolic acid analogues carried higher risk than belimumab (HR 1.55, 95% CI 1.07 to 2.25) and methotrexate (HR 1.32, 1.04 to 1.68). All differences disappeared once time-varying monthly glucocorticoid dose was modelled. A Norwegian registry study matched 2,932 adults with juvenile idiopathic arthritis to 29,097 population comparators and found higher prevalence of hypertension (3.6% vs 1.4%), type 1 diabetes (1.7% vs 0.7%), coeliac disease (1.4% vs 0.7%) and chronic kidney disease (0.5% vs 0.2%), with all-cause mortality 2.4 against 1.8 per 1,000 person-years; recent DMARD exposure made no difference. And a meta-analysis of 15 studies and 19,015 children with juvenile idiopathic arthritis found pooled antithyroid antibody positivity of 4% with a risk difference of 0.08 against controls, most strongly predicted by a family history of thyroid autoimmunity (OR 3.91).
Class I recall: glass particles in Tyenne tocilizumab vials
Check your unit's tocilizumab stock against this recall today, and inspect every vial against light before drawing up.
Adults with juvenile idiopathic arthritis carry a heavier comorbidity load
Treat adults with juvenile idiopathic arthritis as a cardiometabolic and autoimmune screening population, and assign that screening explicitly at transition.
Who to screen for thyroid autoimmunity in juvenile arthritis
Screen thyroid function selectively in juvenile arthritis - family history, antinuclear positivity, older onset - rather than universally.
Write the glucocorticoid taper as dates, not as instructions
Write every glucocorticoid taper as dated steps with a review date, and total cumulative exposure at each annual review.
In lupus, the infection risk followed the steroid, not the immunosuppressant
Treat monthly glucocorticoid dose as the infection risk you can change, and pick the immunosuppressant on efficacy rather than on infection ranking.
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