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Anyone on SAPHNELO or Anifrolumab for LUPUS?
Saphnelo or Anifrolumab weekly pen injection is now in Phase III clinical trial for Systemic Sclerosis. The drug originally has been approved for Lupus, either as once monthly infusion or as weekly pen self-injection. I am considering it for SSC, but I will have to pay out-of pocket as it is not approved yet in this indication.
If you were treated with Saphnelo for any indication, please share your experience with regard to how effective it was, how long did it take to make it work, and major toxicities that you have experienced.
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Drugs.com has Saphnelo experience posted on their website. On the most part, Lupus patients are referring to infusions with most common side effects: fatigue, headache, nausea, respiratory infections.
https://www.drugs.com/comments/anifrolumab/saphnelo.html
Here is a link to DAISY trial of Anifrolumab in Systemic Sclerosis. The study has completed its enrollment. The results and potential approval are expected by April of 2028.
https://clinicaltrials.gov/study/NCT05925803
Saphnelo (anifrolumab) was first FDA-approved for intravenous use in moderate to severe systemic lupus erythematosus (SLE) in 2021, with subcutaneous self-administration approved on April 27, 2026.