Baricitinib Shows High Hair Growth in Teen Alopecia Areata Study
Baricitinib Demonstrates Efficacy in Treating Severe Alopecia Areata
Table of Contents
- Baricitinib Demonstrates Efficacy in Treating Severe Alopecia Areata
- Baricitinib (Olumiant) for Alopecia Areata: Q&A on Efficacy,Safety,and more
New findings presented at the American Academy of Dermatology (AAD) annual meeting in Orlando, held from March 7-11, showcase the potential of baricitinib in treating severe alopecia areata (AA). The phase 3 BRAVE-AA-PEDS study reveals clinically significant improvements in hair regrowth among adolescent patients.
Understanding Alopecia Areata
Alopecia areata is an autoimmune condition characterized by patchy hair loss on the scalp,face,and other areas of the body. This condition can progress over time, impacting individuals of all ages. It’s noted that approximately 40% of AA patients experience the onset of the disease before the age of 20.
BRAVE-AA-PEDS Study Design
The BRAVE-AA-PEDS study involved 257 patients who were randomly assigned to receive either 4 mg of baricitinib, 2 mg of baricitinib, or a placebo, administered orally once daily. The primary goal was to achieve a Severity of Alopecia Tool (SALT) score of ≤20,indicating 80% or more scalp hair coverage,by week 36.
Key Findings at Week 36
At the start of the study, patients exhibited an average of 89% scalp hair loss, with 65% showing minimal or no eyebrow hair (ClinRO score of 2 or 3) and 57% displaying minimal or no eyelash hair (ClinRO score of 2 or 3). By week 36, significant improvements were observed:
- Scalp Hair Regrowth: “60.0% of patients receiving baricitinib 4 mg and 36.9% of patients receiving baricitinib 2 mg experienced at least a 50% improvement in their condition (as measured by SALT score), compared to 5.7% on placebo (p=0.001).”
- 80% or More Scalp Coverage: “42.4% of patients receiving baricitinib 4 mg and 27.4% of patients receiving baricitinib 2 mg achieved 80% or more scalp hair coverage, compared to 4.5% on placebo (p=0.001).”
- 90% or More Scalp Coverage: “36.5% of patients receiving baricitinib 4 mg and 21.4% of patients receiving baricitinib 2 mg had 90% or more scalp hair coverage (SALT ≤10), compared to 2.3% on placebo (p=0.001).”
- Eyebrow Regrowth: “50.0% of patients receiving baricitinib 4 mg and 24.1% of patients receiving baricitinib 2 mg achieved significant eyebrow regrowth (ClinRO scores of 0 or 1 with an improvement of ≥2 points from baseline),compared to 0% on placebo (p < 0.01)."
- Eyelash Regrowth: “42.9% of patients receiving baricitinib 4 mg achieved significant eyelash regrowth,and 25.5% of patients receiving baricitinib 2 mg experienced improved eyelash regrowth, compared to 14.0% on placebo (p=0.002 for 4 mg, p=0.097 for 2 mg).”
Comparison with Adult Studies
The study suggests that adolescents might experience faster hair regrowth compared to adults. In the BRAVE-AA1 and BRAVE-AA2 trials, ”40.9% of adult patients treated with baricitinib 4 mg and 21.2% of patients treated with baricitinib 2 mg achieved 80% or more scalp hair coverage at Week 52.”
Safety Profile
The moast common treatment-related adverse events in BRAVE-AA-PEDS included acne, influenza, and upper respiratory infections. Serious adverse events were more frequent in the placebo group compared to the baricitinib groups. Notably, the study reported no deaths, opportunistic infections, major adverse cardiovascular events, venous thromboembolic events, or malignancies.
The safety profile of baricitinib in adolescents with AA aligned with previous clinical trials involving juvenile idiopathic arthritis and moderate to severe atopic dermatitis. Over 14,600 patients have received baricitinib in clinical trials, including 866 patients aged >1 month to <18 years.
Baricitinib: A JAK Inhibitor
Baricitinib is an oral, once-daily Janus kinase (JAK) inhibitor.
Regulatory Status
in 2022, the U.S. Food and Drug Management (FDA) approved baricitinib (Olumiant) for adult patients with severe AA, marking it as the first systemic treatment approved in the U.S.for this condition. Baricitinib is also approved for treating adults with moderate to severe active rheumatoid arthritis in the U.S. and over 75 countries, for treating patients as young as two years old with moderate to severe atopic dermatitis in over 40 countries, and for adult patients with severe AA in Europe and japan. Furthermore, it has received market authorization in several countries for treating hospitalized patients with COVID-19.
Baricitinib (Olumiant) for Alopecia Areata: Q&A on Efficacy,Safety,and more
This article addresses common questions regarding the use of Baricitinib (olumiant) in treating Alopecia Areata (AA),leveraging findings presented at the American Academy of Dermatology (AAD) annual meeting.
Understanding Baricitinib and Alopecia Areata
What is Alopecia Areata (AA)?
Alopecia areata is an autoimmune disorder characterized by non-scarring hair loss. This can manifest as patchy hair loss on the scalp, face, and othre parts of the body. AA can affect individuals of all ages, with approximately 40% of patients experiencing onset before age 20.
What is Baricitinib (Olumiant)?
Baricitinib is an oral,once-daily Janus kinase (JAK) inhibitor. It effectively works by blocking the activity of certain enzymes involved in inflammation, which are believed to contribute to the progress of alopecia areata.
Is Baricitinib FDA Approved for Alopecia Areata?
Yes, in 2022, the U.S. Food and Drug Administration (FDA) approved baricitinib (Olumiant) for adult patients with severe alopecia areata. It was the first systemic treatment approved in the U.S. for this condition. It is also approved for other conditions, including rheumatoid arthritis, atopic dermatitis, and, in some countries, for treatment of hospitalized patients with COVID-19.
BRAVE-AA-PEDS Study: Baricitinib in Adolescent Alopecia Areata
What is the BRAVE-AA-PEDS study?
The BRAVE-AA-PEDS study is a Phase 3 clinical trial evaluating the efficacy and safety of baricitinib in adolescent patients with severe alopecia areata.New findings were presented at the American Academy of Dermatology (AAD) annual meeting in Orlando.
How was the BRAVE-AA-PEDS study designed?
The BRAVE-AA-PEDS study involved 257 patients who were randomly assigned to receive either 4 mg of baricitinib, 2 mg of baricitinib, or a placebo, administered orally once daily.
What was the primary goal of the BRAVE-AA-PEDS study?
The primary goal was to achieve a Severity of Alopecia Tool (SALT) score of ≤20 by week 36, indicating 80% or more scalp hair coverage.
Key Findings of the BRAVE-AA-PEDS Study
What were the key findings regarding scalp hair regrowth in the BRAVE-AA-PEDS study?
Significant improvements were observed in scalp hair regrowth by week 36:
50% Improvement (SALT Score): 60.0% of patients receiving baricitinib 4 mg and 36.9% of patients receiving baricitinib 2 mg experienced at least a 50% improvement, compared to 5.7% on placebo (p=0.001).
80% or More Coverage: 42.4% of patients receiving baricitinib 4 mg and 27.4% of patients receiving baricitinib 2 mg achieved 80% or more scalp hair coverage, compared to 4.5% on placebo (p=0.001).
90% or More Coverage: 36.5% of patients receiving baricitinib 4 mg and 21.4% of patients receiving baricitinib 2 mg had 90% or more scalp hair coverage (SALT ≤10), compared to 2.3% on placebo (p=0.001).
Did Baricitinib improve eyebrow and eyelash regrowth in adolescents with Alopecia Areata?
Yes, the BRAVE-AA-PEDS study showed improvements in eyebrow and eyelash regrowth:
Eyebrow Regrowth: 50.0% of patients receiving baricitinib 4 mg and 24.1% of patients receiving baricitinib 2 mg achieved significant eyebrow regrowth, compared to 0% on placebo (p < 0.01). * Eyelash Regrowth: 42.9% of patients receiving baricitinib 4 mg achieved significant eyelash regrowth, and 25.5% of patients receiving baricitinib 2 mg experienced improved eyelash regrowth, compared to 14.0% on placebo (p=0.002 for 4 mg, p=0.097 for 2 mg).
Do adolescents experiance faster hair regrowth compared to adults with Baricitinib treatment?
The BRAVE-AA-PEDS study suggests that adolescents might experience faster hair regrowth compared to adults. In the BRAVE-AA1 and BRAVE-AA2 trials, 40.9% of adult patients treated with baricitinib 4 mg and 21.2% of patients treated with baricitinib 2 mg achieved 80% or more scalp hair coverage at Week 52, compared to the higher percentages observed in adolescents at Week 36 in the BRAVE-AA-PEDS study.
Baricitinib Safety Profile
What are the common side effects of Baricitinib in adolescents with Alopecia Areata?
The most common treatment-related adverse events in BRAVE-AA-PEDS included acne,influenza,and upper respiratory infections.
Are there any serious side effects associated with Baricitinib use in adolescents?
Serious adverse events were more frequent in the placebo group compared to the baricitinib groups. Notably, the study reported no deaths, opportunistic infections, major adverse cardiovascular events, venous thromboembolic events, or malignancies. The safety profile of baricitinib in adolescents with AA aligned with previous clinical trials involving juvenile idiopathic arthritis and moderate to severe atopic dermatitis.
How manny patients have received Baricitinib in clinical trials?
Over 14,600 patients have received baricitinib in clinical trials, including 866 patients aged >1 month to <18 years.
Summary of Key Findings
| Outcome | Baricitinib 4mg (%) | Baricitinib 2mg (%) | Placebo (%) |
| —————————- | ——————- | ——————- | ———– |
| ≥50% Improvement (SALT) | 60.0 | 36.9 | 5.7 |
| ≥80% Scalp Coverage | 42.4 | 27.4 | 4.5 |
| ≥90% Scalp Coverage (SALT≤10) | 36.5 | 21.4 | 2.3 |
| Eyebrow Regrowth | 50.0 | 24.1 | 0.0 |
| Eyelash regrowth | 42.9 | 25.5 | 14.0 |