Efficacy

Efficacy of Stelara (ustekinumab) in Treating Psoriasis

Stelara (ustekinumab) is a biologic medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy. Ustekinumab, the active ingredient in Stelara, is a monoclonal antibody that targets interleukin-12 (IL-12) and interleukin-23 (IL-23), two proteins that play a key role in the inflammatory processes associated with psoriasis. Clinical trials have demonstrated that Stelara can lead to significant improvement in psoriasis symptoms, with many patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI 75) score, which is a common measure of psoriasis severity.

Several studies have shown that Stelara has a rapid onset of action, with some patients experiencing improvement in their symptoms as early as 4 weeks after the initial dose. The efficacy of Stelara tends to increase over time, with continued treatment leading to further improvements. Long-term studies suggest that the therapeutic benefits of Stelara can be maintained with ongoing treatment, and the medication has been found to be effective for continuous use over several years.

Efficacy of Wezlana (ustekinumab-auub) in Treating Psoriasis

Wezlana (ustekinumab-auub) is a biosimilar to Stelara, which means it is highly similar to the reference product in terms of safety, purity, and potency, but it is not identical. Biosimilars are developed to provide comparable therapeutic outcomes to their reference products at potentially lower costs. Wezlana has been approved by the FDA for the treatment of moderate to severe plaque psoriasis in adult patients. The efficacy of Wezlana in treating psoriasis has been evaluated in comparative clinical trials, which have shown that it is similar to Stelara in terms of its ability to reduce the severity and extent of psoriatic lesions.

The approval of Wezlana was based on a totality of evidence, including analytical, preclinical, and clinical data that demonstrated Wezlana's similarity to Stelara. In clinical trials, Wezlana met the pre-specified criteria for equivalence in efficacy to Stelara, with comparable safety and immunogenicity profiles. Patients treated with Wezlana have shown improvements in PASI scores that are similar to those treated with the reference product, indicating that Wezlana is an effective treatment option for individuals with moderate to severe plaque psoriasis.