Trial Outcomes & Findings for Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab. (NCT NCT01320293)

NCT ID: NCT01320293

Last Updated: 2016-12-26

Results Overview

Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-12-26

Participant Flow

Participant milestones

Measure	Adalimumab active Adalimumab: 40mg subcutaneously, every other week for 6 months
Overall Study STARTED	18
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Adalimumab active Adalimumab: 40mg subcutaneously, every other week for 6 months
Overall Study Lack of Efficacy	1
Overall Study Adverse Event	1

Baseline Characteristics

Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

Baseline characteristics by cohort

Measure	Adalimumab n=18 Participants active Adalimumab: 40mg subcutaneously, every other week for 6 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39 years n=5 Participants
Gender Female	6 Participants n=5 Participants
Gender Male	12 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.

Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).

Outcome measures

Measure	Adalimumab n=17 Participants active Adalimumab: 40mg subcutaneously, every other week for 6 months
Percentage Change in Endothelial Function Compared to Baseline.	-1.414 percent change Interval -1.86 to -0.97

SECONDARY outcome

Timeframe: 6 months

Population: 17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.

IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.

Outcome measures

Measure	Adalimumab n=17 Participants active Adalimumab: 40mg subcutaneously, every other week for 6 months
Changes in IL-6 Profile Compared to Baseline	-0.92 pg/ml Interval -0.93 to -0.91

SECONDARY outcome

Timeframe: 24 weeks

Population: 17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.

Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.

Outcome measures

Measure	Adalimumab n=17 Participants active Adalimumab: 40mg subcutaneously, every other week for 6 months
Changes in Adiponectin Profile Compared to Baseline	6.125 pg/ml Interval -9.24 to 21.49

Adverse Events

Adalimumab

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adalimumab n=18 participants at risk active Adalimumab: 40mg subcutaneously, every other week for 6 months
Skin and subcutaneous tissue disorders allergic drug reaction	5.6% 1/18 • Duration of study- 6 months

Other adverse events

Measure	Adalimumab n=18 participants at risk active Adalimumab: 40mg subcutaneously, every other week for 6 months
Respiratory, thoracic and mediastinal disorders upper respiratory tract infection	22.2% 4/18 • Number of events 4 • Duration of study- 6 months
Gastrointestinal disorders heartburn	5.6% 1/18 • Number of events 1 • Duration of study- 6 months
Musculoskeletal and connective tissue disorders elbow strain	5.6% 1/18 • Number of events 1 • Duration of study- 6 months

Additional Information

Aida Lugo-Somolinos MD

University of North Carolina

Phone: 919-843-9447

Email: alugosom@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60