Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Remsima

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Ghurki Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.
• Arsiwala S. Infliximab: efficacy in psoriasis. Indian J Dermatol Venereol Leprol. 2013 Jul;79 Suppl 7:S25-34. doi: 10.4103/0378-6323.115525.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): August 5, 2023

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: D7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No