Comparative assessment of effectiveness between oral cyclosporine and oral methotrexate in patients with moderate to severe plaque psoriasis: a prospective, parallel-group observational study

Title of Study

Comparative assessment of effectiveness between oral cyclosporine and oral methotrexate in patients with moderate to severe plaque psoriasis  a prospective, parallel-group observational study.

Introduction

Plaque psoriasis is a chronic inflammatory dermatological disorder with significant physical and psychosocial impact. Methotrexate and cyclosporine are established systemic therapies for moderate to severe cases, but comparative data on their effectiveness and safety in Indian patients remain limited and inconsistent. This study aims to directly compare both agents regarding disease improvement and adherence over 16 weeks.

Objectives

Primary Objective To assess and compare the change in Psoriasis Area and Severity Index   PASI    score from baseline to 16 weeks between oral cyclosporine and oral methotrexate.

Secondary Objective To compare patient adherence rates at 16 weeks using the Simplified Medication Adherence Questionnaire   SMAQ    scale in both treatment groups.

Methodology

a Materials and Methods

Study design is Prospective, parallel-group, observational study.

Location is Dermatology OPD of tertiary care teaching hospital.

Duration is 24 months   July 2025–July 2027   .

Enrolment Patients will be allocated to receive either oral cyclosporine or oral methotrexate, as per dermatologist discretion, with standard topical adjuncts   emollients, corticosteroids   . Four scheduled follow-up visits   at 4, 8, 12, and 16 weeks   .

b Inclusion Criteria

Age 18–65 years   inclusive   , any gender.

Moderate to severe plaque psoriasis   PASI  greater than  or equal to10   , diagnosis by dermatologist.

New patients prescribed one of the study drugs.

less than  or equal to16 weeks prior systemic therapy, documented PASI at defined intervals.

Adjunct topical therapy allowed.

Written informed consent.

c Exclusion Criteria

Non plaque psoriasis subtypes.

Use of other systemic anti psoriatic therapies or biologics in combination.

History of drug allergy   methotrexate or cyclosporine   , malignancy, pregnancy, significant liver or renal impairment.

Determined unsuitable by treating dermatologist.

d Endpoints

Primary Endpoint Change in mean PASI score from baseline to 16 weeks.

Secondary Endpoints

Proportion of patients attaining PASI75 at 16 weeks.

Proportion of patients adherent to therapy   SMAQ score equal to 0 at 16 weeks   .

e Primary Outcome

Mean reduction in PASI score at week 16 between groups.

f Secondary Outcomes

Proportion with PASI75 response.

Proportion with good adherence to cyclosporine and methotrexate   SMAQ score equal to 0   .

 Study Procedure

Eligibility screening, signed informed consent.

Baseline clinical examination, history, PASI scoring.

Allocation to Group A   cyclosporine    or Group B   methotrexate    per standard prescribing.

Regular follow ups at 4, 8, 12, 16 weeks with repeat PASI scoring and adherence assessment.

Data recorded in case record forms.

Drug Availability

Both drugs   oral cyclosporine and oral methotrexate    are available at the study site and prescribed as per routine clinical practice. Folic acid supplementation provided with methotrexate.

Data Collection

Clinical data and adherence scores will be documented at each visit in standardized electronic and paper forms.

Statistical Analysis

Sample size  80   40 per group   , with 10percentage dropout rate anticipated.

Unpaired t test for mean change in PASI.

ANCOVA to adjust for baseline PASI.

Logistic regression for prognostic factors related to treatment success/failure.

Repeated measures ANOVA for within group PASI changes.

Chi square for PASI75 and adherence rates.

Analysis performed via GraphPad Prism and SPSS v26 p less than 0.05 is significant.

Ethical Consideration

Study conducted under institutional ethics committee approval, following ICMR, Good Clinical Practice, Declaration of Helsinki. Written informed consent required privacy and confidentiality assured patients free to withdraw at any time.

Expected Impact

This study will provide robust comparative evidence on the efficacy, safety, and adherence of oral cyclosporine and methotrexate in moderate to severe plaque psoriasis among Indian patients, guiding future therapeutic decisions and standard of care protocols.