SUMMARY

• The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
• Clinical studies have not been conducted to evaluate the safety and efficacy of STELARA in the treatment of guttate psoriasis (PsO).
• Case series and case reports have described the use of STELARA in patients with guttate PsO.^1-3

CLINICAL DATA

Case Series

Brummer et al (2017)¹ described 6 cases of recalcitrant guttate PsO that were treated successfully with STELARA.

• Patient 1 was a 38-year-old male with guttate PsO, involving 20% of his body surface area (BSA), which coincided with recurrent streptococcal pharyngitis. His Physician Global Assessment (PGA) score was 3. He did not respond to topical steroids, oral prednisone, or cyclosporine. He received a single dose of STELARA 90 mg, resulting in complete clearance in less than 4 weeks. He remained clear for more than 16 months without additional doses of STELARA.
• Patient 2 was a 25-year-old female who developed guttate PsO after suffering a broken leg. Subsequent flares of her PsO were associated with recurrent episodes of streptococcal pharyngitis. Her BSA involvement was 5%, with an overall PGA score of 2. She did not respond to multiple courses of antibiotics, narrowband ultraviolet B therapy, or topical steroids. She was treated with STELARA 90 mg at weeks 0 and 8. Improvement began after the first injection, and she was almost clear at week 8 and was completely clear at 6 months. She received 3 additional injections of STELARA 45 mg at weeks 23, 35, and 58 and has remained clear with only occasional use of topical steroids.
• Patient 3 was a 29-year-old male with guttate PsO that developed after streptococcal pharyngitis. He did not respond to treatment with topical steroids, oral prednisone, and cyclosporine. He received STELARA 45 mg at weeks 0, 6, 18 and 30. At the time of the fourth injection, he had complete clearance and remained clear for more than 20 months until he flared up after an episode of pharyngitis. He received 2 additional doses of STELARA 45 mg 4 weeks apart, with significant improvement after the initial dose.
• Patient 4 was a 26-year-old male who was being treated with certolizumab pegol for Crohn’s disease (CD) and had guttate PsO after streptococcal pharyngitis. His BSA involvement was 5%, with an overall PGA score of 2. He did not respond to topical steroids, topical pimecrolimus, and cyclosporine. Certolizumab pegol was discontinued, and he received STELARA 90 mg at weeks 0 and 6, then every 8 weeks. His BSA involvement decreased from 5% to 1% after the first injection, and his skin was completely clear by the third injection. He remained clear for more than 2 years while continuing STELARA injections every 8 weeks for CD.
• Patient 5 was a 42-year-old female with a history of mild plaque PsO who had a guttate flare after streptococcal pharyngitis. Her BSA involvement was 40%, with an overall PGA score of 2. She failed to respond to treatment with narrowband ultraviolet B therapy and cyclosporine. She received STELARA 45 mg at weeks 0 and 4 and was completely clear at week 12. She remained clear for more than 3 months before reverting to a baseline mild disease.
• Patient 6 was a 35-year-old female who was being treated with apremilast for chronic plaque PsO and had a severe guttate PsO flare after streptococcal pharyngitis. Her BSA involvement was 10%, with an overall PGA score of 3. She failed to respond to treatment with topical steroids and cyclosporine. She received STELARA 90 mg at weeks 0 and 4 and was completely clear at 3 months. She remained clear for 7 months without additional doses of STELARA.
• No serious adverse effects were reported in any of the 6 patients.

Case Reports

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® databases (and/or other resources, including internal/external databases) was conducted on 13 May 2024.