Effect of Semaglutide on the Inflammatory Response and Clinical Course of Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus
Phase: PHASE4
Conditions: Psoriasis Vulgaris, Diabetes Type 2
Sponsor: University of Banja Luka

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Effect of Semaglutide on the Psoriatic Lesion in Patients 
With Type 2 Diabetes Mellitus 
 
 
Date : 03.may 2023. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.  Study design 
Observational, prospective study, interventional cohort study was conducted at the University 
Clinical Centre of the Republic of Srpska, the Skin and Venereal Diseases Clinic. 
Cohort 1. Patients with DMT2 and psoriasis, who are already on metformin therapy in the 
maximally tolerated dose and to whom semaglutide will be introduced into the therapy, according 
to the Instructions for the drug, approved by the Agency for medicinal products and medical 
devices of Bosnia and Herzegovina (ALIMS BIH), as well as the indications approved by the 
Health Insurance Fund of the Republic of Srpska, namely: DMT2, BMI >30 kg/m2, HbA1c >7% 
in the maximum tolerated dose of semaglutide (0.25mg, 0.5mg per week or 1.0mg per week). 
Cohort 2. Patients with DMT2 and psoriasis, who are already on metformin therapy in the 
maximally tolerated dose and other oral antidiabetics, except on therapy with GLP-1 RA and 
SGLT-2 inhibitors.  
The patients were treated with semaglutide, they received the drug free of charge, and at the 
suggestion of a specialist endocrinologist in doses and according to the method of administration 
(subcutaneous) as described in the Instructions for the drug use. The drug is registered for use by 
ALIMS BIH. 
Subjects: A total of 30 patients divided into two cohorts, one is patients with DMT2 and psoriasis 
who received the drug semaglutide along with previous antidiabetic therapy, the other is patients 
with psoriasis and DMT2, but who remained on the current antidiabetic therapy and did not receive 

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the drug semaglutide. In all patients, the diagnosis of psoriasis was made on the basis of a typical 
clinical picture, the existence of clearly limited erythematous plaques with non-adherent whitish 
squamous, determined by clinical examination and scoring by means of the PASI score (2). 30 
subjects were included in the research itself, namely two groups of 15 subjects. One group 
consisted of 15 subjects with psoriasis and DMT2 on metformin therapy who were prescribed 
semaglutide according to the existing indication for the drug, and the other control group consisted 
of 15 subjects with psoriasis and DMT2 who were on metformin or any other antidiabetic therapy, 
except for GLP-1 agonists. Subjects corresponded comparatively by age and gender. 
The age of the subjects in both groups was from 18-70 years, and the sample included subjects of 
both sexes. The aforementioned selection of subjects and the size of the sample itself ensured 
representativeness of the sample and objective research results for the examined population. 
Criteria for inclusion in the study: Patients who signed a personal consent to participate in the 
study, patients with a typical clinical picture of moderately-severe to severe plaque psoriasis (PASI 
SCORE ≥10) and DMT2 diagnosed at least 6 months before inclusion in the study, patients who 
receive therapy prescribed by endocrinologist, patients who were not treated with 
immunosuppressive therapy. 
Criteria for non-inclusion in/exclusion from the study: Other forms of psoriasis, other chronic, 
inflammatory diseases (data obtained by reviewing the medical history), drugs that can cause the 
appearance of psoriasis (lithium, systemic antimalarials, systemic corticosteroids) - for the past 3 
months, systemic therapy of vulgaris psoriasis 3 months before inclusion in the study, patients on 
therapy with other GLP-1 RAs except semaglutide (liraglutide, dulaglutide, lixisenatide), SGLT-2 
inhibitors (empagliflozin and dapagliflozin) and NSAIDs, photo UVB therapy, patients who did 
not personally sign consent to participate in the study. 

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Criteria for exclusion from the study: Subject's request for exclusion from the study, patients 
diagnosed with another pathological condition, adverse reactions to semaglutide described in the 
available Instructions for the drug: nausea, vomiting, allergic reaction at the localization of drug 
administration. 
 
Clinical and demographic characteristics of patients 
The severity and activity of the disease was determined by the PASI score and the DLQI Index 
twice in total during the research, during the first and second visit. Determination of the presence 
of MS in subjects was performed according to the IDF (International Diabetes Federation) 
definition. 
To assess disease activity, i.e. skin surface affected by changes (erythema, infiltration and extent 
of squamous matter), the PASI score was used. Assessment of the clinical picture of psoriasis using 
the PASI score, by using the above-mentioned method, was performed a total of two times, during 
the 3 months that the research lasted. 
All demographic characteristics of the patients, as well as anthropometric parameters, were also 
collected. Medical history was used for general demographic and social epidemiological data 
(name and surname, date of birth, age, gender), as well as anthropometric measurements (body 
height and weight, body mass index-BMI). 
 
Biochemical analyses 
Biochemical analyses were performed on the blood sample of the subjects, 12-14 hours after the 
last meal, a total of two times during the research, during the first and second visit, and the patients 
were informed about this beforehand. Part of the serum was used to determine the concentration 
of fasting glucose, fasting insulin, HgbA1C, urate, total cholesterol, triglycerides, and LDL and 
HDL cholesterol, which was performed at the Institute for Laboratory Diagnostics of the 

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University Clinical Centre of the Republic of Srpska. The second part of the serum was used to 
determine the concentration of serum TNF-α, IL-1β, IL-6, IL-17, CRP and IL23. The final analysis 
of these biochemical parameters was carried out at the Center for Biomedical Research of the 
Faculty of Medicine of the University of Banja Luka. The safety of the use of semaglutide, i.e. its 
side effects (the most common side effects: nausea, vomiting, allergic reaction at the localization 
of drug application) was also monitored by telephone in patients diagnosed with DMT2 and 
psoriasis. 
 
 Measurement techniques 
Serum concentration of  TNF-α, IL-1β, IL-6, IL-17, CRP and IL23, fasting glycemia values and 
HbA1c were determined from venous blood, as well as determination of insulin, urate, total 
cholesterol, triglycerides, LDL and HDL-cholesterol in the serum. The patients were monitored 
clinically and laboratory (PASI SCORE and DLQI, HbA1c, fasting GUC, fasting insulin, urate, 
lipid status) during two study visits in the period of 0 and 3 months, and the mentioned parameters 
were measured twice in total. 
Baseline visit: Before the start of the clinical examination and serum sampling, the patients were 
required to sign the Patient Informed Consent, in which all procedures were explained, as well as 
patients’ rights and obligations during the study trial in which they will voluntarily participate. 
After signing the Informed Consent, a clinical examination by a dermatovenerologist (PASI and 
DLQI) and an endocrinologist was performed, as well as blood sampling for biochemical and 
hormonal analyzes of blood sugar (GUC), cholesterol, HDL cholesterol, LDL cholesterol, 
triglycerides, insulin, HbA1c, urate. Blood samples were taken (a total of two test tubes) at the 
Institute for Laboratory Diagnostics of the University Clinical Center of the Republic of Srpska, 
at no cost to the patients. 

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During the next 12 weeks of the study, the patient was called by phone, every month - a total of 3 
times - in order to confirm the administration of the drug or the possible existence of adverse 
reactions to the drug, described in the available Instructions for the drug. 
Visit after 12 weeks: the patient underwent a clinical examination by a dermatovenerologist (PASI 
and DLQI) and an endocrinologist, as well as blood sampling for biochemical and hormonal 
analyzes (blood sugar (GUC), cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, 
insulin, HbA1c, urate). Blood samples were taken (a total of two tubes) at the Institute for 
Laboratory Diagnostics of the University Clinical Center of the Republic of Srpska, at no cost to 
the patient.