Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Infliximab Biosimilar Remsima in Treatment of Chronic Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Remsima


Participation Criteria
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Eligibility Criteria
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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. Patient with active tuberculosis. Extremely immunocompromised patient. Patient with cardiac disease. Patient with allergic reaction to REMSIMA. Pregnancy and Lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remsima<br> | Drug: Remsima<br>* The patient will be given one Injection of REMSIMA 120 mg subcutaneously at week 0, 1, 2, 3, 4 and then every 2 weeks i.e., at 6, 8, 10 and 14 weeks. If the weight of the patient is >80 kg, 2 injections will be given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area Severity Index Score | Patients will be followed 4,8,14 and 24 weeks | 24 weeks | 
| Adverse Events | Patients will be followed 4,8,14 and 24 weeks | 24 weeks |