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Dermbits

BI Spevigo September 2023

DO, MPH

What spesolimab-associated hypersensitivity reactions should patients be monitored for? 

Generalized Pustular Psoriasis (GPP)

You? Well, first and foremost, like any systemic therapy, and especially a biologic therapy, like an interleukin 36 inhibitor such as spazolamob, we worry about hypersensitivity reactions in general, allergic reactions, infusion related reactions, which can occur with any monoclonal antibody, including spizolamob. So hypersensitivity reactions in general may include mood, immediate hypersensitivity reactions, like an anaphylaxis, for which we have to be prepared, particularly since this is an infusion or delayed reactions, such as the drug reaction with eosinophilia, and systemic symptoms known as dress. So, in the clinical trials, there actually were two cases of dress which were reported in study FSAL, one in those subjects with GPP who were treated with this agent. Now, it's important to note that there is a regist or an regiscar dress validation scoring system. And what it means is it's either no, it wasn't caused by this agent. Possible, possibly unlikely, but possible, probable and also definite. And so those four categories are what were assessed in this particular clinical trial for these two cases. And it was found that in these two cases, they were reported that it's either no dress or not dress, but no. And also possible dress. And so I think that this gives us pretty good comfort that it may not be related directly to therapy. But I think the most important thing is that we keep an index of suspicion. If a patient develops the signs and symptoms of an anaphylactic or hypersensitivity reaction, we're going to discontinue spizolamob immediately and initiate the proper treatment that we would typically do for supportive care for these patients. But what I also wanted to point out is that sometimes patients will develop what we know is more of a mild or moderate infusion type reaction. And so what we do at that point is stop spizolamob, stop that infusion, consider the appropriate therapy, like hydration and systemic antihistamines, corticosteroids. And then upon resolution of the reaction, the infusion may be restarted, and probably best so at a slower infusion rate.

What spesolimab-associated hypersensitivity reactions should patients be monitored for?

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