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Dear Readers! I started this blog when my daughter was in the NICU. She had ventriculitis. Her CSF report grew E.coli. But, she was injected Teicoplanin directly into her brain. The doctors made two errors here:

Teicoplanin is for gram-positive bacteria only. It does not treat E.coli.
Teicoplanin is not for intraventricular use. The manufacturer strongly discourage injecting Teicoplanin into the brain.

My daughter bled into the brain. She lived for another two years and ultimately died.

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Leqselvi FDA-Approved for Severe Alopecia Areata

Leqselvi is an oral Janus Kinase inhibitor, Deuruxolitinib.

The FDA approved this new oral treatment for patients with severe alopecia areata on 25th of July, 2024.

The FDA approval was based on two large phase III clinical trials, THRIVE-AA1 and THRIVE-AA2.

Here is a summary of the THRIVE-AA1 Clinical Trial:

Efficacy of the Oral JAK1/JAK2 Inhibitor, Deuruxolitinib, in Adult Patients with Alopecia Areata

Alopecia areata (AA) is a challenging autoimmune disorder characterized by partial or complete loss of hair, leading to significant psychosocial impact.

The search for effective treatments has led to the exploration of Janus kinase (JAK) inhibitors, with deuruxolitinib emerging as a promising candidate.

This blog post delves into the findings from the THRIVE-AA1 Phase 3 trial, which assessed the efficacy of deuruxolitinib in adult patients with AA.

Introduction:

Alopecia areata significantly affects patients' quality of life, causing emotional and psychological distress due to hair loss.

Recent studies have shown that JAK inhibitors can potentially reverse hair loss in AA patients.

Deuruxolitinib, an oral JAK1/JAK2 inhibitor, has demonstrated promising results in earlier phase trials.

The THRIVE-AA1 Phase 3 trial was designed to evaluate its efficacy and safety in a larger cohort.

Study Objective:

The primary objective of the THRIVE-AA1 Phase 3 trial was to present key efficacy outcomes of deuruxolitinib in treating adult patients with AA.

Methods:

Eligible patients aged 18-65 with at least 50% scalp hair loss were randomized into three groups:

Placebo
Deuruxolitinib 8 mg BID
Deuruxolitinib 12 mg BID

The primary endpoint was the percentage of patients achieving a SALT (Severity of Alopecia Tool) score of ≤20 at Week 24.

Secondary endpoints included the percentage of patients achieving a SALT score of ≤10 and ≥75% or ≥90% improvement in SALT scores at Week 24.

Results:

The trial enrolled 706 patients, with 156 in the placebo group, 233 in the 8 mg BID group, and 317 in the 12 mg BID group.

Baseline demographics and disease characteristics were comparable across the groups.

Efficacy Findings:

At Week 24, 29.6% and 41.5% of patients treated with 8 mg BID and 12 mg BID deuruxolitinib, respectively, achieved a SALT score ≤20, compared to 0.8% in the placebo group.
Both deuruxolitinib doses showed significant improvement from baseline as early as Week 8.
The percentage of patients achieving a SALT score ≤10 at Week 24 was 21.7% for the 8 mg BID group and 34.3% for the 12 mg BID group, compared to 0% for the placebo group.
A significant number of patients achieved ≥75% and ≥90% relative reduction in SALT scores at Weeks 12 and 24 with both doses of deuruxolitinib compared to placebo.

Conclusions:

The THRIVE-AA1 Phase 3 trial demonstrated that deuruxolitinib is highly effective in treating AA:

Both 8 mg BID and 12 mg BID doses met the primary efficacy endpoint with a significant number of patients achieving a SALT score ≤20 at Week 24.
The treatment resulted in substantial hair regrowth, beginning as early as Week 8 and continuing throughout the trial.
Deuruxolitinib 12 mg BID was particularly superior in efficacy compared to the 8 mg BID dose.

Overall, deuruxolitinib shows great promise as a treatment for AA, offering hope to patients struggling with this challenging condition.

References:

Senna, M. M., King, B., Mesinkovska, N. A., Mostaghimi, A., Hamilton, C., & Cassella, J. (2024). Efficacy of the oral JAK1/JAK2 inhibitor CTP-543 (deuruxolitinib) in adult patients with alopecia areata: Results from the multinational, double-blind, placebo-controlled THRIVE-AA1 Phase 3 trial.
FDA Approved New Oral Treatment for Alopecia Areata

Disclosure:

This blog post is based on data presented in the THRIVE-AA1 Phase 3 trial poster and has been summarized for educational purposes.

By staying informed about the latest research, healthcare providers can offer the best possible care to patients with alopecia areata. For more detailed insights, you can refer to the full study or visit our website for further updates.