{"id":{"repo_id":"utswmed","oai_identifier":"oai:utswmed-ir.tdl.org:2152.5/10607"},"canonical_url":"https://search.dev.ndltd.org/etd/utswmed/oai:utswmed-ir.tdl.org:2152.5/10607","repository":{"repo_id":"utswmed","name":"University of Texas Southwestern Medical Center","base_url":"https://utswmed-ir.tdl.org/server/oai/request"},"display":{"title":"A Study of Female and Minority Representation in Clinical Trials and Patterns of Loading Dose Use in Biologic Therapies for Hidradenitis Suppurativa and Psoriasis","abstract":"This thesis includes 2 separate documents: [Part One] A Study of Female and Minority Representation in Clinical Trials and [Part Two] Patterns of Loading Dose Use in Biologic Therapies for Hidradenitis Suppurativa and Psoriasis.","abstract_html":"This thesis includes 2 separate documents: [Part One] A Study of Female and Minority Representation in Clinical Trials and [Part Two] Patterns of Loading Dose Use in Biologic Therapies for Hidradenitis Suppurativa and Psoriasis.","abstract_has_math":false,"creators":["Greif, Charlotte Swann"],"institution":null,"degree_name":null,"degree_level":null,"degree_discipline":null,"degree_department":null,"school":null,"contributors":["Nijhawan, Rajiv I.","Srivastava, Divya","Porter, Martina L."],"advisors":[],"committee_chairs":[],"committee_members":[],"year":2025,"date_issued":"2025-06-03T19:52:40Z","date_published":"2025-06-03T19:52:40Z","updated_at":"2026-07-24T05:52:13Z","subjects":["Biological Factors","Biological Products","Hidradenitis Suppurativa","Psoriasis","Randomized Controlled Trials as Topic","Retrospective Studies"],"languages":["en"],"rights":[],"rights_urls":[],"identifier_entries":[{"key":"dc:identifier","label":"Identifier","values":["1522122353"],"render_values":[{"text":"1522122353","href":null,"code":true}]}]},"links":{"outbound_url":"https://hdl.handle.net/2152.5/10607","outbound_label":"Handle","outbound_source":"dc:identifier"},"metadata_groups":[{"id":"people","label":"People","entries":[{"key":"dc:contributor","label":"Contributor","values":["Nijhawan, Rajiv I.","Srivastava, Divya","Porter, Martina L."]},{"key":"dc:creator","label":"Author","values":["Greif, Charlotte Swann"]}]},{"id":"academic_context","label":"Academic Context","entries":[{"key":"dc:date","label":"Dc Date","values":["2025-06-03T19:52:40Z","2023-05","May 2023"]},{"key":"dc:type","label":"Dc Type","values":["Thesis","text"]}]},{"id":"subjects_keywords","label":"Subjects and Keywords","entries":[{"key":"dc:subject","label":"Dc Subject","values":["Biological Factors","Biological Products","Hidradenitis Suppurativa","Psoriasis","Randomized Controlled Trials as Topic","Retrospective Studies"]}]},{"id":"language_rights","label":"Language and Rights","entries":[{"key":"dc:language","label":"Dc Language","values":["en"]}]},{"id":"identifiers","label":"Identifiers","entries":[{"key":"dc:identifier","label":"Identifier","values":["https://hdl.handle.net/2152.5/10607","1522122353"]}]},{"id":"additional","label":"Additional Metadata","entries":[{"key":"dc:description","label":"Description","values":["This thesis includes 2 separate documents: [Part One] A Study of Female and Minority Representation in Clinical Trials and [Part Two] Patterns of Loading Dose Use in Biologic Therapies for Hidradenitis Suppurativa and Psoriasis.","[Female and Minority Representation in Clinical Trials for Hidradenitis Suppurativa and Psoriasis] BACKGROUND: It is well established that females and minorities are under-represented in clinical research despite legislative efforts to promote their inclusion. Several studies have found this trend to be true in clinical trials for hidradenitis suppurativa (HS) and psoriasis (PsO). OBJECTIVE: To identify any differences in demographic breakdowns of HS and PsO patients between healthcare settings to uncover any causative healthcare disparities. METHODS: This systematic review reports racial, ethnic, and sex makeup of HS and PsO patient populations across the emergency department (ED), inpatient, clinical trial, and registry settings. 95% confidence intervals are used as proxies of statistical significance to compare demographic breakdowns between settings. RESULTS: Female, Hispanic, and Black patients were under-represented in HS clinical trials compared to their population prevalences (Female: 63.7% (61.4-66.0%) vs. 73.5% (72.8-74.3%); Hispanic: 3.8% (1.4-6.3%) vs. 12.0% (11.4-12.6%); Black: 9.1% (6.3-11.8% vs. 20.3% (19.6%-20.9%)). White patients were over-represented (76.6% (72.5-80.6%) vs. 59.9% (59.1%-60.7%)). Female and Black patients were under-represented in PsO clinical trials compared to their population prevalences (Female: 33.0% (32.6-33.5%) vs. 54.8% (49.8-59.8%); Black: 2.2% (2.0-2.4%) vs. 5.7% (3.4-8.0%)). Black patients were over-represented in the inpatient and emergency department (ED) settings in HS (inpatient vs. emergency department vs. population prevalence: 49.9% (49.3-50.6%) vs. 49.9% (49.7-50.1%) vs. 20.3% (19.6-20.9%) and in the inpatient setting in PsO (inpatient vs. population prevalence: 19.8% (19.1-20.6%) vs. 5.7% (3.4-8.0%). CONCLUSION: The finding that females and minority groups are under-represented in HS and PsO clinical trials is consistent with the published literature. Black patients appear to be over-represented in the acute care setting compared to other groups, the reason for which is likely multifactorial.","[Patterns of Loading Dose Use in Biologic Therapies for Hidradenitis Suppurativa and Psoriasis] BACKGROUND: There are few published studies directly comparing the clinical effectiveness of biologic therapy regimens with loading doses to those without loading doses, and there is no clear pattern of loading dose use. Published reasons for the use of loading doses include faster achievement of therapeutic drug levels, reduced time to clinical response, prevention or neutralization of anti-drug antibodies, and the need for more drug to gain control of an inflammatory disease than maintain control. OBJECTIVE: To identify any patterns of loading dose use in biologic therapies. METHODS: All FDA-approved biologic therapies for plaque psoriasis and their recommended regimens in all indications were tabulated (Table 1). The total amount of drug recommended in weeks one through twelve and thirteen through twenty-four were considered the loading dose and maintenance dose, respectively. The amount of drug recommended in each twelve-week period was normalized by dividing by the maximum amount of each biologic drug recommended for any indication in that same period. For each indication and twelve-week period, normalized values were added, and the sum was divided by the total number of approved biologic therapies in that indication. This yielded the average recommended biologic dose for a given indication in each 12-week period. These average doses were classified into quartiles by comparing them to other indications within the same 12-week period. A high dose of biologic therapy was considered to fall within quartile one or two and a low dose, within quartile three or four. RESULTS: In HS, PsO, and uveitis, high loading and maintenance doses were recommended relative to other indications. In Crohn's disease and ulcerative colitis, high loading doses and low maintenance doses were recommended. In rheumatoid arthritis and psoriatic arthritis, low loading doses and high maintenance doses were recommended. In non-axial spondyloarthritis, low loading and maintenance doses were recommended. CONCLUSION: The use of loading doses was found to cluster by specialty. The reason for this pattern is unclear and may have several possible explanations."]},{"key":"dc:format","label":"Dc Format","values":["application/pdf"]},{"key":"dc:title","label":"Title","values":["A Study of Female and Minority Representation in Clinical Trials and Patterns of Loading Dose Use in Biologic Therapies for Hidradenitis Suppurativa and Psoriasis","Patterns of Loading Dose Use in Biologic Therapies for Hidradenitis Suppurativa and Psoriasis"]}]}],"canonical_facts":{"dc:contributor":["Nijhawan, Rajiv I.","Srivastava, Divya","Porter, Martina L."],"dc:creator":["Greif, Charlotte Swann"],"dc:date":["2025-06-03T19:52:40Z","2023-05","May 2023"],"dc:description":["This thesis includes 2 separate documents: [Part One] A Study of Female and Minority Representation in Clinical Trials and [Part Two] Patterns of Loading Dose Use in Biologic Therapies for Hidradenitis Suppurativa and Psoriasis.","[Female and Minority Representation in Clinical Trials for Hidradenitis Suppurativa and Psoriasis] BACKGROUND: It is well established that females and minorities are under-represented in clinical research despite legislative efforts to promote their inclusion. Several studies have found this trend to be true in clinical trials for hidradenitis suppurativa (HS) and psoriasis (PsO). OBJECTIVE: To identify any differences in demographic breakdowns of HS and PsO patients between healthcare settings to uncover any causative healthcare disparities. METHODS: This systematic review reports racial, ethnic, and sex makeup of HS and PsO patient populations across the emergency department (ED), inpatient, clinical trial, and registry settings. 95% confidence intervals are used as proxies of statistical significance to compare demographic breakdowns between settings. RESULTS: Female, Hispanic, and Black patients were under-represented in HS clinical trials compared to their population prevalences (Female: 63.7% (61.4-66.0%) vs. 73.5% (72.8-74.3%); Hispanic: 3.8% (1.4-6.3%) vs. 12.0% (11.4-12.6%); Black: 9.1% (6.3-11.8% vs. 20.3% (19.6%-20.9%)). White patients were over-represented (76.6% (72.5-80.6%) vs. 59.9% (59.1%-60.7%)). Female and Black patients were under-represented in PsO clinical trials compared to their population prevalences (Female: 33.0% (32.6-33.5%) vs. 54.8% (49.8-59.8%); Black: 2.2% (2.0-2.4%) vs. 5.7% (3.4-8.0%)). Black patients were over-represented in the inpatient and emergency department (ED) settings in HS (inpatient vs. emergency department vs. population prevalence: 49.9% (49.3-50.6%) vs. 49.9% (49.7-50.1%) vs. 20.3% (19.6-20.9%) and in the inpatient setting in PsO (inpatient vs. population prevalence: 19.8% (19.1-20.6%) vs. 5.7% (3.4-8.0%). CONCLUSION: The finding that females and minority groups are under-represented in HS and PsO clinical trials is consistent with the published literature. Black patients appear to be over-represented in the acute care setting compared to other groups, the reason for which is likely multifactorial.","[Patterns of Loading Dose Use in Biologic Therapies for Hidradenitis Suppurativa and Psoriasis] BACKGROUND: There are few published studies directly comparing the clinical effectiveness of biologic therapy regimens with loading doses to those without loading doses, and there is no clear pattern of loading dose use. Published reasons for the use of loading doses include faster achievement of therapeutic drug levels, reduced time to clinical response, prevention or neutralization of anti-drug antibodies, and the need for more drug to gain control of an inflammatory disease than maintain control. OBJECTIVE: To identify any patterns of loading dose use in biologic therapies. METHODS: All FDA-approved biologic therapies for plaque psoriasis and their recommended regimens in all indications were tabulated (Table 1). The total amount of drug recommended in weeks one through twelve and thirteen through twenty-four were considered the loading dose and maintenance dose, respectively. The amount of drug recommended in each twelve-week period was normalized by dividing by the maximum amount of each biologic drug recommended for any indication in that same period. For each indication and twelve-week period, normalized values were added, and the sum was divided by the total number of approved biologic therapies in that indication. This yielded the average recommended biologic dose for a given indication in each 12-week period. These average doses were classified into quartiles by comparing them to other indications within the same 12-week period. A high dose of biologic therapy was considered to fall within quartile one or two and a low dose, within quartile three or four. RESULTS: In HS, PsO, and uveitis, high loading and maintenance doses were recommended relative to other indications. In Crohn's disease and ulcerative colitis, high loading doses and low maintenance doses were recommended. In rheumatoid arthritis and psoriatic arthritis, low loading doses and high maintenance doses were recommended. In non-axial spondyloarthritis, low loading and maintenance doses were recommended. CONCLUSION: The use of loading doses was found to cluster by specialty. The reason for this pattern is unclear and may have several possible explanations."],"dc:format":["application/pdf"],"dc:identifier":["https://hdl.handle.net/2152.5/10607","1522122353"],"dc:language":["en"],"dc:subject":["Biological Factors","Biological Products","Hidradenitis Suppurativa","Psoriasis","Randomized Controlled Trials as Topic","Retrospective Studies"],"dc:title":["A Study of Female and Minority Representation in Clinical Trials and Patterns of Loading Dose Use in Biologic Therapies for Hidradenitis Suppurativa and Psoriasis","Patterns of Loading Dose Use in Biologic Therapies for Hidradenitis Suppurativa and Psoriasis"],"dc:type":["Thesis","text"]},"updated_at":"2026-07-24T05:52:13Z"}