DefinePK

Research Objective

To compare the efficacy of oral Tofacitinib added to NB-UVB phototherapy versus Tofacitinib monotherapy in patients with vitiligo.

Methodology

An open-label, non-randomized study conducted at the Department of Dermatology, JPMC, Karachi from April 2024 to September 2024. 40 patients aged 18 and above, diagnosed with vitiligo with stable lesions for at least six months, were included. Patients were divided into two groups: Group B (n=20) received oral Tofacitinib 5 mg twice daily, and Group A (n=20) received oral Tofacitinib 5 mg twice daily in combination with NB-UVB phototherapy three times weekly. The Vitiligo Area Scoring Index (VASI) was used to quantify depigmentation at baseline and 12 weeks. Efficacy was defined as 51% improvement in re-pigmentation.

Methodology Flowchart

                        graph TD;
    A["Ethical Approval & Patient Recruitment"] --> B["Patient Stratification into Two Groups"];
    B --> C["Group A: Tofacitinib + NB-UVB"];
    B --> D["Group B: Tofacitinib Alone"];
    C --> E["12 Weeks Treatment"];
    D --> E;
    E --> F["VASI Score Measurement Baseline & 12 Weeks"];
    F --> G["Efficacy Assessment ≥51% Re-pigmentation"];
    G --> H["Statistical Analysis"];
    H --> I["Conclusion"];                    

Discussion

The study suggests that combining oral Tofacitinib with NB-UVB phototherapy leads to better therapeutic outcomes in vitiligo patients compared to Tofacitinib monotherapy. The combination therapy demonstrated greater re-pigmentation, likely due to the synergistic effects of Tofacitinib suppressing immune-mediated melanocyte destruction and NB-UVB promoting melanocyte proliferation and migration. Autoimmune comorbidities were found to be significantly higher in the Tofacitinib alone group, potentially impacting treatment response.

Key Findings

At 12 weeks, the Tofacitinib + NB-UVB group showed a significant improvement in VASI score (36.8 ± 8.3) compared to the Tofacitinib alone group (54.15 ± 9.5) (p < 0.0001). The percentage improvement in VASI was significantly higher in the combination therapy group (57.4 ± 9.7%) versus the monotherapy group (36.7 ± 9.9%) (p < 0.0001). Efficacy outcome (≥51% re-pigmentation) was achieved in 75% of patients in the Tofacitinib + NB-UVB group compared to 5% in the Tofacitinib alone group (p < 0.0001).

Conclusion

Oral Tofacitinib combined with NB-UVB phototherapy is more effective than Tofacitinib monotherapy for re-pigmentation in vitiligo patients, demonstrating higher VASI score improvements and a greater proportion of patients achieving significant re-pigmentation.

Fact Check

1. Study Duration: The study was conducted from April 2024 to September 2024. (Confirmed)
2. Sample Size: A total of 40 patients were included in the study, divided equally into two groups of 20. (Confirmed)
3. Efficacy Threshold: Efficacy was defined as achieving 51% improvement in re-pigmentation. (Confirmed)

Mind Map