Outcome of Treatment With Secukinumab in the Treatment of Moderate to Severe Plaque Psoriasis at Tertiary Care Hospital.

Psoriasis is one of the most common immune-mediated inflammatory disorders characterized by a chronic course. It affects approximately 2-3% of the world's population Psoriasis may be provoked by environmental factors in patients with genetic predispositions. Psoriasis is phenotypically characterized by thickened, red, scaly plaques and systemic inflammation, it is also associated with multiple comorbidities, such as cardiovascular disease, stroke, hypertension, metabolic diseases, chronic kidney disease, and joint destruction. Psoriasis is pathogenically driven by proinflammatory cytokines and mediated by T and dendritic cells. Inflammatory myeloid dendritic cells release interleukin (IL) 23 and IL-12 to activate IL-17-producing T cells, Th1 cells, and Th22 cells to produce psoriatic cytokines like IL-17, interferon (IFN) γ, TNF, and IL-22. These cytokines mediate the effects on keratinocytes. Secukinumab is a recombinant human monoclonal antibody that specifically binds to a proinflammatory cytokine released by T-helper-17 (Th17) cells, IL-17A. It blocks its binding with IL-17R and the expression of cytokines. This blockade normalizes the inflammatory processes and combats epidermal hyperproliferation, T-cell infiltration, and exaggerated expression of pathogenic genes.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Secukinumab Injection

Detailed Description

Plaque psoriasis is a chronic autoimmune skin disorder characterized by the formation of thick, scaly plaques on the skin surface. It affects millions of individuals worldwide and significantly impacts their quality of life. While several treatment options exist, a substantial number of patients with moderate to severe plaque psoriasis fail to achieve satisfactory results or experience intolerable side effects with conventional therapies.

Psoriasis is pathogenically driven by proinflammatory cytokines and mediated by T cells and dendritic cells. In recent years, the advent of biologic agents targeting specific immune pathways has revolutionized the management of psoriasis. Secukinumab, a fully human monoclonal antibody that selectively inhibits interleukin-17A, has shown promising results in randomized controlled trials and real-world studies. However, there remains a need to assess the real-world effectiveness and safety of Secukinumab in routine clinical practice, particularly in patients with moderate to severe plaque psoriasis who may have diverse characteristics and treatment histories.

This observational study aims to evaluate the real-world effectiveness and safety of Secukinumab in patients with moderate to severe plaque psoriasis. By collecting data from a diverse patient population in routine clinical settings, we aim to provide valuable insights into the outcomes and experiences of patients receiving Secukinumab outside the controlled environment of clinical trials.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75510
      • Jinnah Post graduate Medical Centre

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Known plaque psoriasis
• Either gender
• Age 30-80 years.

Exclusion Criteria:

• Patients with history of eczema.
• Patients with history connective tissue disorder, vasculitis malignancy, seropositive or seronegative arthritis.
• Patients with history of malignancy.
• Patient with history of hepatis B, C or AIDS.
• Immunocompromised patients.
• Pregnant patients assessed by history and confirmed by dating scan.
• Patients with history of chronic liver disease, chronic kidney disease, asthma, acute coronary syndrome, congestive heart failure and chronic obstructive pulmonary disease will be excluded.

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: Secukinumab; Injection Secukinumab 150mg subcutaneously will be administered at weeks 0, 1, 2, 3, 4, and then monthly for 5 months.	Drug: Secukinumab Injection; Injection Secukinumab 150mg subcutaneously will be administered at weeks 0, 1, 2, 3, 4, and then monthly for 5 months.; Other Names: Cosentyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Secukinumab in the treatment of moderate to severe plaque psoriasis	Efficacy will be assessed using psoriasis area and severity index. The minimum score of psoriasis area and severity index is 0 and the maximum score is 72. All patients who will be presented with 75% reduction in the Psoriasis Area and Severity Index at the end of the therapy compared to baseline will be labelled as positive for efficacy.	From day of randomisation until final dose of drug,assessed upto 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference of Psoriasis Area and Severity Index score before and after the treatment	Psoriasis area and severity index score difference before the treatment and after the treatment will be measured	From day of randomisation until final dose of drug,assessed upto 12 months.

Collaborators and Investigators

• Sponsor: Jinnah Postgraduate Medical Centre
• Investigators: Principal Investigator: Faiza I Siddiqui, Jinnah Post graduate Medical Centre; Principal Investigator: Rabia Ghafoor, Jinnah Post graduate Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): June 5, 2022
• Study Completion (Actual): July 10, 2022

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: June 4, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 4, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Plaque Psoriasis; Outcome; Secukinumab Injection
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: NO.F2-81/2022-GENL/252/JPMC

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
• product manufactured in and exported from the U.S.: No