The International Dermatology Outcome Measures group has determined 6 core domains that should be considered mandatory for all future clinical trials for psoriasis therapies, according to results published in JAMA Dermatology.
The domains are skin manifestations, psoriasis and psoriatic arthritis symptoms, health-related quality of life, investigator global assessment, patient global assessment, and treatment satisfaction.
Previously, there was no consensus on which domains should be measured or which instruments should be used in clinical trials for psoriasis therapies.
The researchers used a literature review, pre-Delphi survey exercises, nominal group discussions, and audience voting at 4 stakeholder meetings to develop candidate domains for 2 rounds of a Delphi survey. The stakeholders included patients or advocates of patients with psoriasis and healthcare professionals with expertise in psoriasis.
After 2 rounds of Delphi surveys, the researchers considered a domain “core” if both patient and healthcare professional groups reached a threshold consensus of at least 70%. If a domain reached consensus in 1 but not both groups, it was considered important, but not required to be measured in all trials. Domains that did not reach consensus in either group were considered to be of uncertain importance and placed in the research agenda.
In the first round, 107 healthcare professionals and 14 patients participated. In the second round, 77 healthcare professionals and 15 patients participated.
Of the 20 candidate domains, 6 met consensus in both groups to be core domains: skin manifestations, psoriasis and psoriatic arthritis symptoms, health-related quality of life, investigator global assessment, patient global assessment, and treatment satisfaction.
The following domains met consensus in 1 group and were labeled important: secondary skin manifestations, nail psoriasis, inverse psoriasis, genital psoriasis, and guttate psoriasis.
Psoriatic arthritis signs, work productivity or participation, direct economic impact, indirect economic impact, and cardiovascular disease did not reach consensus in either group, and thus made up the research agenda.
“The next steps of IDEOM will be to develop work groups that use the core domain set as a guide to evaluate the existing instruments as candidates for core measurement sets,” wrote the researchers.
This study was funded in part by IDEOM, a 501(c)(3) nonprofit organization that is supported by corporate sponsorships from AbbVie, Amgen, Celgene Corp, Dermira, Eli Lilly and Company, Leo Pharma, Novartis, Sun Pharmaceutical Industries Ltd, UCB, Valeant, and Sienna Biopharmaceuticals and by private donors, including Advancing Innovation in Dermatology. REDCap is supported by grant 8UL1TR000105 (formerly UL1RR025764) from the National Center for Advancing Translational Sciences.
Duffin KC, Merola JF, Christensen R, et al. Identifying a core domain set to assess psoriasis in clinical trials [published online June 6, 2018]. JAMA Dermatol. doi: 10.1001/jamadermatol.2018.1165