Comparative analysis of dexamethasone cyclophosphamide pulse therapy and conventional corticosteroid therapy in pemphigus vulgaris

Pemphigus with a chronic relapsing remitting course requires long-term immunosuppression. Oral steroids, corticosteroids of therapy, are associated with severe complications in the long term. To bypass these limitations, DCP has emerged as an alternative modality aiming to induce faster remission and reduce cumulative steroid burden. Though (antibody against CD20) is approved as first-line therapy in Pemphigus by the FDA in 2018, its high cost, need for immunization against various infectious agents, and pretreatment evaluation requiring extensive evaluation make it less affordable for the common Indian masses. In response to these limitations, DCP is still preferred in many centers. Limited comparative clinical data exist. On its efficacy and safety compared to an oral steroid regimen. Therefore, this study seeks to evaluate and compare clinical efficiency, safety, and relapse rate in Indian patients in both groups. And aims to contribute evidence-based recommendations for imperative management strategies in Pemphigus Vulgaris.

Study Type - Prospective comparative interventional study

Place - Department of Dermatology, MGMC&H.

Study Duration - 12 months

Sample Size - 25 in each group. Total 50 patients.

Sample Size Justification - Based on previous studies and clinical experiences we assume a moderate effect size(Cohen’s D =7) between two treatment groups with respect to clinical outcome such as time to remission, cumulative steroid dose, DLQI and disease severity score . Using two tailed test with a significance level of .05, 95% confidence and a power of 80 percent minimum required sample size was estimated to be 17/group .Accounting for a 20% dropout rate, the final sample size was set at 42 patients. (21/group)

Type of Data Collection - Primary

Intervention:

Group A (DCP Therapy)

Dexamethasone 100mg IV in 5% dextrose over 2 -3 hours for 3 continuous days + cyclophosphamide 500 mg IV on day 2 on each pulse.

Pulse repeated at 28 weeks interval with a 50 ml oral cycle of cyclophosphamide in between pulses

Group B (Conventional Therapy)

Daily one prednisolone 40 - 120 mg (~1 ~1.5/kg day) was started with adjuvant(cyclophosphamide or dapsone). Steroid doses were tapered of according to

response and reduced to maintenance doses (15 - 60 mg OD or EOD). Once stabilized, attempts were made to withdraw steroids

Monitoring Parameter:

PDAI

DLQI score

Lab investigations

Adverse drug event

Key end points:

Time to initiate response

Skin

Mucosa

Time for complete remission

Relapse rates

During treatment

After treatment

Adverse Events

Steroid exposure & hospital stay

Statistical Analysis

Discrete & continuous data expressed as count (percentage) & median (range) respectively.

Risk and Benefit

Patients may experience side effects from treatment, such as infections, weight gain, or drug-related effects. They may benefit from receiving structured and monitored care and study findings may help improve featured treatment.