Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis

Ghurki Trust and Teaching Hospital

Status and phase

Completed

Phase 4

Conditions

Psoriasis

Treatments

Drug: Remsima

Study type

Interventional

Funder types

Other

Identifiers

NCT06043752

Details and patient eligibility

About

Psoriasis is a persistent condition which demands prolonged management, so it puts heavy financial as well as psychological burden on patients. Severe psoriasis makes work impossible for patients. If it affects exposed parts of the body, it may lead to decrease in self-esteem, social avoidance, and shame. Patients with even mild form of psoriasis have high stigma as compared to other cutaneous diseases. As a result, psoriasis affected individuals experience greater difficulty in social interactions and employment. Patients experience symptoms in psoriasis includes bleeding, itching and inflamed joints. Psoriatic patients develop psoriatic arthritis approximately at 40 years of age which contributes to fatigue in these individuals. Moreover, early age onset of psoriasis leads to more physical impairment. Hence, patients get trapped in a vicious cycle as stress leads to further aggravation of disease. The European Medicine Agency has given its approval regarding the usage of INFLIXIMAB bio similar REMSIMA for psoriasis after taking in consideration its effectiveness from other studies conducted on ankylosing spondylitis and rheumatoid arthritis. This study is being conducted as no data is present on REMSIMA SC in psoriasis patient in Pakistan.

Enrollment

51 patients

Sex

All

Ages

18 to 59 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18-59 years
Both genders
Diagnosed patient of Psoriasis
Moderate to severe psoriasis
Not responding to topical treatment
Not responding to conventional systemic treatments i.e., methotrexate, cyclosporine and phototherapy.
PASI score >10.

Exclusion criteria

Patient with active systemic lupus erythematosus or ANA positive patients.