The edition · Clinical Pharmacology
Lowering IgG with efgartigimod did not add benefit to steroids in pemphigus
A phase III trial shows a clear pharmacodynamic effect that failed to reach the clinic, while a review finds over-the-counter cannabidiol doses do little except interact.
The edition in brief
In the ADDRESS phase III trial, 222 adults with moderate to severe pemphigus received prednisone with either weekly subcutaneous efgartigimod, a neonatal Fc receptor blocker, or placebo. Efgartigimod rapidly lowered total IgG and anti-desmoglein antibodies, but complete remission on minimal prednisone by week 30 did not differ (35.5% vs 30.3%; OR 1.19, 0.60–2.41), nor did total steroid use. A review in the British Journal of Clinical Pharmacology found that low-dose cannabidiol, the range sold without prescription, produces exposures 5 to 100 times lower than licensed doses and shows little consistent therapeutic effect, yet interactions with THC, amitriptyline and hydromorphone were seen at these doses. A Drug Safety paper examines why switching from innovator to generic products generates reports of failure and adverse effects despite bioequivalence standards. The FDA lists Class II recalls of compounded tirzepatide and semaglutide combined with cyanocobalamin, for lack of sterility assurance. The pearl covers taking a complete drug history that includes supplements.
Over-the-counter cannabidiol doses do little, but can still interact
Ask about CBD use, explain that low doses show little benefit, and check for interactions with co-prescribed drugs.
Why switching to a generic can generate reports of failure
Investigate problems after a generic switch, especially with narrow-margin drugs, and report them rather than dismiss them.
Class II recalls of compounded incretin and vitamin combinations
Ask where a patient's incretin comes from, and treat vitamin-combination products as compounded and outside the licensed supply.
A drug history is not complete without supplements
Ask about supplements and traditional remedies by category, and record what and how much.
ADDRESS: efgartigimod with prednisone did not improve pemphigus remission
Do not use efgartigimod for pemphigus; it lowered autoantibodies but did not improve remission over steroids alone.
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