The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors

The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors: Α Ten-year Prospective Observational Study.

The investigators conducted a prospective study which included all patients diagnosed with biopsy-proven BP in the Dermatology Department of Attikon hospital between April 1, 2009 and December 31, 2019. 113 consecutive patients with BP were identified. The investigators included the patients with type 2 diabetes and investigated the percentage of patients who were under treatment with DPP4-is. The specific DPP4-i prescribed was also documented.Medical information including patients' age, sex, other comorbidities and concomitant medications were also recorded. Furthermore, the investigators evaluated the effect of different types of treatment (topical steroids, systemic corticosteroids, immunosuppressive agents) on bullous pemphigoid.

Study Overview

• Status: Unknown
• Conditions: Bullous Pemphigoid

Detailed Description

Bullous pemphigoid (BP) is the most common chronic autoimmune skin disease which is characterized by the presentation of subepidermical blisters and mostly affects elderly patients . Recent studies have suggested that dipeptidyl peptidase-4 inhibitors (DPP-4is), an incretin-based drug for type 2 diabetes, as possible predisposing agents of BP . The objective of the study was to estimate the association between the use of DPP-4is and the development of BP in the setting of a tertiary university hospital and to raise awareness for everyday clinical practice, both among dermatologists as well as all physicians following patients with diabetes The study was designed as an observational prospective study.In the study included all patients who received a new diagnosis of BP and hospitalized in the Dermatology Department of our hospital between April 1, 2009 and December 31, 2019 Inclusion Criteria included a) biopsy proven bullous pemphigoid b) severe bullous pemphigoid c) recent manifestation of bullous pemphigoid (last four months).Exclusion Criteria included a) non bullous pemphigoid b) presentation of bullous pemphigoid more than four months c) treatment with DPP4is more than two years.

Overall, 113 consecutive patients with the diagnosis of BP were enrolled in the study.The investigators reviewed the percentage of patients with type 2 diabetes among all patients with BP.The number of patients who were under treatment with DPP4-is and the specific type of DPP4-is prescribed were also examined.

• Study Type: Observational
• Enrollment (Anticipated): 113

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 12462
      • "ATTIKON" University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

In the study included all patients diagnosed with biopsy-proven BP in the Dermatology Department of Attikon hospital between April 1, 2009 and December 31, 2019.

Description

Inclusion Criteria:

• biopsy proven bullous pemphigoid
• severe bullous pemphigoid
• recent manifestation of bullous pemphigoid (last four months)

Exclusion Criteria:

• non bullous pemphigoid
• presentation of bullous pemphigoid more than four months
• treatment with DPP4is more than two years

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Τhe correlation between the use of DPP-4is and the development of Bullous pemphigoid	The investigators assessed the percentage of patients who were under treatment with DPP4-is among patients with bullous pemphigoid	baseline

Collaborators and Investigators

• Sponsor: University of Athens
• Investigators: Principal Investigator: Vaia Lambadiari, MD,PhD, 2nd department of internal medicine,University of Athens,Greece; Principal Investigator: Evangelia Papadavid, MD,PhD, 2nd department of dermatology and venereology,University of Athens, Greece; Principal Investigator: Aikaterini Kountouri, MD, 2nd department of internal medicine,University of Athens,Greece; Principal Investigator: Emmanouil Korakas, MD, 2nd department of internal medicine,University of Athens,Greece; Principal Investigator: Sofia Theotokoglou, 2nd department of dermatology and venereology,University of Athens, Greece; Principal Investigator: Konstantinos Theodoropoulos, 2nd department of dermatology and venereology,University of Athens, Greece; Principal Investigator: Ignatios Ikonomidis, MD,PhD, 2nd department of cardiology,University of Athens,Greece

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2009
• Primary Completion (Actual): September 9, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Skin Diseases, Vesiculobullous; Pemphigoid, Bullous
• Other Study ID Numbers: BP-DPP4is

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No