Product information and disease description Place of product in therapy Approaches to treatment Current treatment options and standard of care

Limitations of current therapies

6 evidence topics · 4 sources

Summary

A treatment review included 118 publications, of which 19% reported clinical trial results. A separate biologics meta-analysis identified moderate heterogeneity and publication bias as limitations affecting reliability. In a U.S. flare-episode analysis, 122 of 513 episodes (24%) had no dermatologic treatment in the interval encompassing the 30 days before, during, and 30 days after the flare. These findings describe limitations of the evidence base and observed treatment delivery; they do not establish comparative efficacy between imsidolimab and existing therapies.

Treatment gaps during flare episodes

“(24% [122 of 513]) had no dermatologic treatment 30 days before, during, or 30 days after a flare episode.” (opens the source at this quote in a new tab)

Biologics systematic review and single-arm meta-analysis

“Moderate heterogeneity and publication bias in the included studies may affect the reliability of the results.” (opens the source at this quote in a new tab)

Treatment systematic literature review

“In total, 118 publications were included, with only 19% of publications reporting on the results of clinical trials.” (opens the source at this quote in a new tab)

National Psoriasis Foundation consensus: access to approved therapy

“We strongly advocate for timely access to US Food and Drug Administration-approved therapies for GPP because delays can increase the risk of mortality in patients with this rapidly progressing disease.” (opens the source at this quote in a new tab)
“Spesolimab is the first US Food and Drug Administration-approved treatment that is highly effective in the treatment of GPP flares in adults.” (opens the source at this quote in a new tab)
“Timely access to approved therapies is critical to reducing morbidity and mortality in patients presenting with GPP.” (opens the source at this quote in a new tab)

National Psoriasis Foundation consensus: diagnostic criteria should not gate treatment

“Skin biopsy is not required for the diagnosis of GPP because histologic features may be nonspecific and it may delay treatment of this life-threatening condition.” (opens the source at this quote in a new tab)
“Although GPP phenotype classification criteria from the European Rare and Severe Psoriasis Expert Network and Japanese Dermatological Association are informative for clinical trials, these criteria should not be used to deny or delay treatment in clinical practice.” (opens the source at this quote in a new tab)
“in patients presenting with acute GPP, one should not wait to fulfill certain arbitrary definitions of GPP before initiating treatment.” (opens the source at this quote in a new tab)