Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Remsima
|
Drug: Remsima
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.
|
Outcome Measures
Primary Outcome Measures
- Psoriasis Area Severity Index Score [24 weeks]
Patients will be followed 4,8,14 and 24 weeks
- Adverse Events [24 weeks]
Patients will be followed 4,8,14 and 24 weeks
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 18-59 years
-
Both genders
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Diagnosed patient of Psoriasis
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Moderate to severe psoriasis
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Not responding to topical treatment
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Not responding to conventional systemic treatments i.e., methotrexate, cyclosporine and phototherapy.
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PASI score >10.
Exclusion Criteria:
Patient with active systemic lupus erythematosus or ANA positive patients.
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Patient with active tuberculosis.
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Extremely immunocompromised patient.
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Patient with cardiac disease.
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Patient with allergic reaction to REMSIMA.
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Pregnancy and Lactation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ghurki Hospital | Lahore | Punjab | Pakistan |
Sponsors and Collaborators
- Ghurki Trust and Teaching Hospital
Investigators
- Study Director: Prof. Dr. Haroon Nabi, Professor Department of Dermatology LMDC
- Principal Investigator: Dr. Nabigha Khalid, Department of Dermatology Ghurki Hospital
- Study Chair: Dr. Saleha Batool, Assistant Professor Department of Dermatology, SIMS Hospital
- Study Chair: Dr. Sumera Hanif, Senior Registrar Dermatology Department
- Study Chair: Dr. Talat Masood Akbar, Associate Professor Dermatology LMDC GTTH
- Study Chair: Dr. Faria Asad, Professor/ Head of Dermatology Department
Study Documents (Full-Text)
None provided.More Information
Publications
- Arsiwala S. Infliximab: efficacy in psoriasis. Indian J Dermatol Venereol Leprol. 2013 Jul;79 Suppl 7:S25-34. doi: 10.4103/0378-6323.115525.
- Chaudhari U, Romano P, Mulcahy LD, Dooley LT, Baker DG, Gottlieb AB. Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial. Lancet. 2001 Jun 9;357(9271):1842-7. doi: 10.1016/s0140-6736(00)04954-0.
- Gisondi P, Bianchi L, Conti A, Dapavo P, Malagoli P, Piaserico S, Savoia F, Prignano F, Girolomoni G. Infliximab biosimilar CT-P13 in the treatment of chronic plaque psoriasis: data from the Psobiosimilars registry. Br J Dermatol. 2017 Dec;177(6):e325-e326. doi: 10.1111/bjd.15659. Epub 2017 Nov 22. No abstract available.
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