What are the side effects of the drug spevigo?

How common are side effects with Spevigo?

Spevigo (spesolimab) is given as a single intravenous dose for generalized pustular psoriasis flares. In the pivotal trial, the most frequently reported adverse reactions were asthenia and fatigue (9 %), nausea and vomiting (6 %), headache (6 %), pruritus and rash (6 %), and infusion-site bruising or swelling (6 %).

What reactions led to treatment discontinuation?

Four of 51 treated patients stopped therapy after the single infusion; the events were drug reaction with eosinophilia and systemic symptoms (DRESS), hypersensitivity, urticaria, and one infusion-related reaction.

Are infections a concern?

Serious infections occurred in 3.9 % of patients, including one case of urinary tract infection and one of subcutaneous abscess. Tuberculosis reactivation has not been observed, but patients are screened for latent TB before treatment.

How does Spevigo affect laboratory values?

Transient decreases in neutrophil counts were seen in 8 % of patients, returning to baseline within two weeks. Elevations in liver enzymes were mild and reversible.

What happens if a patient receives a second dose?

In an open-label extension, a repeat 900 mg infusion 12 weeks later produced a safety profile comparable to the first dose, with no new signals.

Who makes Spevigo and when does the patent expire?

Spevigo is manufactured by Boehringer Ingelheim. The composition-of-matter patent listed on DrugPatentWatch.com is expected to expire in 2037 [1].

Can biosimilars enter before patent expiry?

No biosimilar applications have been filed to date, and regulatory exclusivity in the United States runs until 2034.

What side effects are patients asking about?

Online forums commonly mention infusion reactions that begin during or shortly after the 90-minute infusion, transient fatigue lasting up to a week, and mild skin itching that resolves without additional treatment.

[1] https://www.drugpatentwatch.com/drug/Spevigo