Clinical Outcomes for Uptitration of Baricitinib Therapy in Patients With Severe Alopecia Areata: A Pooled Analysis of the BRAVE-AA1 and BRAVE-AA2 Trials

Justin M Ko; Tiffany T Mayo; Wilma F Bergfeld; Yves Dutronc; Guanglei Yu; Susan G Ball; Najwa Somani; Brittany G Craiglow

doi:10.1001/jamadermatol.2023.2581

. 2023 Aug 9;159(9):970–976. doi: 10.1001/jamadermatol.2023.2581

Clinical Outcomes for Uptitration of Baricitinib Therapy in Patients With Severe Alopecia Areata

A Pooled Analysis of the BRAVE-AA1 and BRAVE-AA2 Trials

Justin M Ko ^1,^✉, Tiffany T Mayo ², Wilma F Bergfeld ³, Yves Dutronc ⁴, Guanglei Yu ⁴, Susan G Ball ⁴, Najwa Somani ⁴, Brittany G Craiglow ⁵

¹Department of Dermatology, Stanford University School of Medicine, Stanford, California

²Department of Dermatology, Heersink School of Medicine, University of Alabama at Birmingham

³Departments of Dermatology and Histopathology, Cleveland Clinic Foundation, Cleveland, Ohio

⁴Eli Lilly and Company, Indianapolis, Indiana

⁵Department of Dermatology, Yale School of Medicine, New Haven, Connecticut

Accepted for Publication: June 13, 2023.

Published Online: August 9, 2023. doi:10.1001/jamadermatol.2023.2581

^✉

Corresponding Author: Justin M. Ko, MD, MBA, Department of Dermatology, Stanford University School of Medicine, 450 Broadway St, Pavilion C 2/F, MC5334, Redwood City, CA 94063 (jmko@stanford.edu).

Author Contributions: Drs Ko and Dutronc had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Ko, Dutronc, Ball.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Dutronc, Ball.

Critical review of the manuscript for important intellectual content: All authors.

Statistical analysis: Yu.

Administrative, technical, or material support: Mayo.

Supervision: Dutronc.

Conflict of Interest Disclosures: Dr Ko reported other support from Eli Lilly and Company for clinical trial conduct and consulting regarding study design during the conduct of the study, as well as serving as a clinical trial investigator for Pfizer and Concert Pharmaceuticals outside the submitted work. Dr Mayo reported grants from Acelyrin, Bristol Myers Squibb, Chemocentryx, Galderma, Janssen, Eli Lilly and Company, and Pfizer, as well as personal fees from Arcutis, Bristol Myers Squibb, Eli Lilly and Company, Bodewell/Procter and Gamble, Leo, Novartis, Pfizer, and Physician Education Resources outside the submitted work. Dr Bergfeld reported being the primary investigator during the study. Dr Dutronc reported serving as a full-time employee for and shareholder in Eli Lilly and Company during the conduct of the study. Dr Yu reported serving as a full-time employee for and shareholder in Eli Lilly and Company during the conduct of the study. Dr Ball reported serving as an employee for and shareholder in Eli Lilly and Company during the conduct of the study as well as having a patent for Olumiant licensed to Eli Lilly and Company. Dr Somani reported serving as an employee for and minor shareholder in Eli Lilly and Company outside the submitted work. Dr Craiglow reported personal fees from AbbVie, Concert Pharmaceuticals, Incyte, Eli Lilly and Company, Pfizer, Regeneron, and Sanofi-Genzyme outside the submitted work. No other disclosures were reported.

Funding/Support: This study was funded by Eli Lilly and Company under license from Incyte.

Role of the Funder/Sponsor: Eli Lilly and Company was involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Meeting Presentation: A portion of this work was presented as an abstract and poster at the 19th Annual Maui Derm Dermatology Meetings; January 23-27, 2023; Maui, Hawaii.

Data Sharing Statement: See Supplement 3.

Additional Contributions: We thank all of the patients and trial staff who participated in these trials. Medical writing and editorial support were provided by Fionn T. McSwiney, PhD, and Sarah A. Ryan, MS, of Eli Lilly and Company. They were not compensated outside of their salaries.

^✉

Corresponding author.

PMCID: PMC10413213 PMID: 37556146

This pooled analysis aims to determine the efficacy of uptitration to baricitinib, 4 mg, for 24 weeks in patients who had previously not responded to baricitinib, 2 mg.

Key Points

Question

What is the benefit of uptitration to baricitinib, 4 mg, for 24 weeks among patients with severe alopecia areata who did not respond to baricitinib, 2 mg (Severity of Alopecia Tool score >20), after 52 weeks of therapy?

Findings

In this pooled analysis of 2 phase 3 randomized clinical trials, 25% of baricitinib, 2 mg, nonresponders who uptitrated to baricitinib, 4 mg, achieved at least 80% scalp coverage (Severity of Alopecia Tool score ≤20) by week 76.

Meaning

Patients with severe alopecia areata not achieving successful regrowth of scalp hair with baricitinib, 2 mg, may benefit from uptitration to baricitinib, 4 mg.

Abstract

Importance

Baricitinib is an oral selective Janus kinase 1/2 inhibitor that has achieved clinically meaningful outcomes for scalp, eyebrow, and eyelash hair regrowth in patients with severe alopecia areata (AA) at week 36 of treatment. Treatment with baricitinib, 4 mg, has resulted in higher response rates than baricitinib, 2 mg, at weeks 36 and 52.

Objective

To determine the efficacy of uptitration to baricitinib, 4 mg, for 24 weeks in patients who had previously not responded to baricitinib, 2 mg (Severity of Alopecia Tool [SALT] score of >20).

Design, Setting, and Participants

BRAVE-AA1 and BRAVE-AA2 are multicenter, placebo-controlled, phase 3 randomized clinical trials that were initiated on September 24, 2018, and July 8, 2019, respectively, with follow-up to 200 weeks (data cutoffs of November 11, 2021, and November 5, 2021, respectively). This pooled analysis reports long-term extension data up to week 76. At baseline, 1200 adult patients with severe AA (SALT score ≥50) were randomly assigned in a 3:2:2 ratio to receive baricitinib, 4 mg; baricitinib, 2 mg; or placebo. Patients treated with baricitinib remained on the same treatment dose until week 52. Patients were considered nonresponders to baricitinib, 2 mg, if they had a SALT score greater than 20 after 52 weeks of therapy.

Main Outcomes and Measures

The proportions of patients achieving a SALT score of 20 or lower and clinician-reported outcome for eyebrow hair loss and eyelash hair loss scores of 0 or 1 (full coverage or minimal gaps) with 2-point or higher improvements from baseline (among those with baseline scores ≥2 [significant gaps to no notable hair]) were analyzed through week 76.

Results

At week 52, of the 340 patients (mean [SD] age, 38.4 [12.9] years; 212 [62.4%] female) treated with baricitinib, 2 mg, 212 (62.4%) had a SALT score higher than 20 and were uptitrated to baricitinib, 4 mg. Two-thirds of these patients (142 of 212 [67.0%]) had a baseline SALT score of 95 to 100, indicating very severe AA. At week 76, 55 of the 212 patients (25.9%) had achieved a SALT score of 20 or lower. During the same period, response rates for clinician-reported outcome scores of 0 or 1 increased from 19.3% (31 of 161 patients) to 37.9% (61 of 161 patients) for eyebrows and from 24.1% (33 of 137 patients) to 40.9% (56 of 137 patients) for eyelashes.

Conclusions and Relevance

In this pooled analysis of the BRAVE-AA1 and BRAVE-AA2 trials, uptitration of baricitinib, 2 mg, to baricitinib, 4 mg, in those who did not respond to the 2-mg dose resulted in meaningful improvement of response rates over the subsequent 24 weeks for scalp, eyebrow, and eyelash hair loss.

Trial Registration

ClinicalTrials.gov Identifiers: NCT03570749 and NCT03899259

Introduction

Alopecia areata (AA) is a common immune-mediated disorder marked by nonscarring hair loss that can affect any hair-bearing site,¹ frequently causing considerable emotional and psychosocial distress.^2,3,4 Hair loss can range from isolated patches to complete hair loss.¹ Patients with more extensive hair loss have a poorer prognosis, and treatment in these patients may be more challenging.⁵ Baricitinib, an oral selective Janus kinase 1/2 inhibitor, is approved for the treatment of adults with severe AA and is in late-stage development for pediatric patients with severe AA.

The baricitinib phase 3 program in severe AA comprised 2 trials (BRAVE-AA1 and BRAVE-AA2) that enrolled adult patients with Severity of Alopecia Tool (SALT) scores of 50 or greater at baseline,⁶ with a majority (53.2%) having very severe AA (SALT score 95-100).⁷ The primary outcome demonstrated that baricitinib, 2 mg, and baricitinib, 4 mg, were superior to placebo in achieving scalp hair regrowth (SALT score ≤20) after 36 weeks of treatment,⁶ and further increases in the proportion of patients achieving a SALT score of 20 or lower were observed after 52 weeks.⁸ At both time points, a dose response was observed with a higher response rate for baricitinib, 4 mg, compared with baricitinib, 2 mg.^6,8 As anticipated, baseline disease characteristics such as baseline severity and duration of the current episode of AA affected the likelihood of treatment response over 52 weeks, with higher response rates being observed in patients with severe AA (SALT score 50-94) compared with those with very severe AA (SALT score 95-100) at baseline⁷ and in patients with a current episode shorter than 4 years compared with those with an episode lasting 4 or more years (eTable 6 in Supplement 1).⁹ Therefore, we studied whether patients initially randomized to baricitinib, 2 mg, and who did not reach a SALT score of 20 or lower after 52 weeks of treatment would benefit from an uptitration to baricitinib, 4 mg, and additionally examined if factors such as baseline disease severity and duration of current AA episode were associated with the response to uptitration.

Methods

Study Design

Pooled data are included from the phase 3 cohorts of BRAVE-AA1¹⁰ and BRAVE-AA2,¹¹ 2 ongoing randomized, double-blind, parallel-group, placebo-controlled studies,⁶ with week 76 data cutoffs of November 11, 2021, and November 5, 2021, respectively. Overall, 1200 patients with severe AA were enrolled in BRAVE-AA1 and BRAVE-AA2. Patients were randomly assigned in a 3:2:2 ratio to receive baricitinib, 4 mg; baricitinib, 2 mg; or placebo at baseline. While patients initially randomized to placebo who were nonresponders (SALT score >20) at week 36 were rescued to baricitinib, 2 mg, or baricitinib, 4 mg, there was no dose change until week 52 for patients randomized to baricitinib treatment arms.

At week 52, all patients randomized at baseline to baricitinib, 2 mg, who were nonresponders (SALT score >20) were uptitrated to baricitinib, 4 mg (Figure 1), in a blinded manner, as prespecified in the protocol. Further details regarding the study design and methods can be found in the primary manuscript⁶ and Supplement 2. At week 76, all patients who had a SALT score higher than 20 at both week 52 and week 76 visits were automatically discontinued from the study unless they had achieved a 2-point or higher improvement in clinician-reported outcome (ClinRO) measures for eyebrow hair loss or eyelash hair loss. Therefore, the efficacy of uptitration was evaluated from week 52 through week 76.

Figure 1. — Patients were considered nonresponders to baricitinib, 2 mg, if they had a Severity of Alopecia Tool (SALT) score greater than 20 at week 52, at which time the dose was uptitrated to baricitinib, 4 mg, for 24 weeks. The main reason for discontinuation of patients reported as Other was the automatic discontinuation of nonresponders at week 76.

The BRAVE-AA1 and BRAVE-AA2 studies were conducted in accordance with ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines, and the research protocols were approved by each center’s institutional review board or ethics committee. All patients provided written informed consent. This study followed Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines.

Efficacy End Points and Subgroups

The proportion of patients achieving a SALT score of 20 or lower (80% scalp coverage) was analyzed through week 76, reflecting a 24-week uptitration treatment period with baricitinib, 4 mg. Efficacy outcomes also included the proportion of patients with a 50% or higher (SALT₅₀) and 75% or higher (SALT₇₅) improvement in SALT score from baseline, as well as the proportion of patients achieving ClinRO for eyebrow hair loss and eyelash hair loss scores of 0 or 1 (full coverage or minimal gaps) with 2-point or higher improvements from baseline (among those with baseline scores ≥2 [significant gaps to no notable hair]). The proportion of patients achieving a SALT score of 20 or lower was also examined by baseline illness characteristics (severe AA [SALT score 50-94] and very severe AA [SALT score 95-100]) and duration of current episode (<4 years and ≥4 years).

Statistical Analysis

Descriptive statistics are summarized using nonresponder imputation for missing data. Secondary censoring rule excludes data collected after permanent study drug discontinuation. Statistics were performed using SAS Enterprise Guide 8 (SAS Institute).

Results

Disposition and Baseline Characteristics

Of the 1200 patients enrolled in BRAVE-AA1 and BRAVE-AA2, 340 and 515 patients were randomized to receive baricitinib, 2 mg, and baricitinib, 4 mg, at baseline, respectively (Figure 1). At week 52, 212 (62.4%) patients receiving baricitinib, 2 mg, were nonresponders (SALT score >20) and were uptitrated to baricitinib, 4 mg (Figure 1). Among the nonresponders, the mean (SD) SALT score at baseline was 90.1 (16.0), and 142 (67.0%) of these patients had very severe AA (SALT score 95-100) compared with 193 (56.8%) in the original baricitinib, 2 mg, cohort (Table). At week 52, nonresponders had a mean (SD) SALT score of 69.6 (28.1). The proportion of patients with a current episode of 4 years or longer was also greater among the nonresponders compared with the original cohort (83 [39.2%] vs 110 [32.4%]). By week 76, 61 (28.8%) patients discontinued the uptitration substudy, a majority of whom were automatically discontinued (reported among the Other category in Figure 1).

Table. Baseline Demographics and Disease Measures Among Patients by Dose.

Characteristic	No. (%)^a
Characteristic	Baricitinib, 2 mg (n = 340)	Uptitrated to baricitinib, 4 mg (n = 212)
Age, mean (SD), y	38.4 (12.9)	37.5 (13.3)
Sex
Female	212 (62.4)	125 (59.0)
Male	128 (37.6)	87 (41.0)
Race
Asian	125 (36.9)	80 (37.7)
Black	19 (5.6)	12 (5.7)
White	185 (54.6)	113 (53.3)
Other^b	10 (2.9)	7 (3.3)
BMI, mean (SD)	26.1 (5.3)	26 (5.4)
Duration of AA since onset, mean (SD), y	12.6 (10.7)	12.8 (10.5)
Duration of current AA episode
<4 y	230 (67.6)	129 (60.8)
≥4 y	110 (32.4)	83 (39.2)
Patients with alopecia universalis^c	153 (45.0)	105 (49.5)
SALT score, mean (SD)	86.3 (18.0)	90.1 (16.0)
Severity
Severe (SALT score 50-94)	147 (43.2)	70 (33.0)
Very severe (SALT score 95-100)	193 (56.8)	142 (67.0)
ClinRO measures^d
Eyebrow hair loss score of 2 or 3	240 (70.6)	161 (75.9)
Eyelash hair loss score of 2 or 3	200 (58.8)	137 (64.6)

Open in a new tab

Abbreviations: AA, alopecia areata; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); ClinRO, clinician-reported outcome; SALT, Severity of Alopecia Tool.

^{^a}

The denominator may vary based on the actual total reported in each category.

^{^b}

Includes patients who identified as American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, and more than 1 race. This category was grouped together owing to small sample sizes.

^{^c}

As assessed by the investigator.

^{^d}

ClinRO scores of 2 indicate considerable gaps in eyebrows or eyelashes, and scores of 3 indicate no notable eyebrows or eyelashes.

Efficacy End Points

Scalp

At week 76, 55 of 212 (25.9%) baricitinib, 2 mg, nonresponders who were uptitrated to the 4-mg dose had achieved a SALT score of 20 or lower (Figure 2A). At week 52, 39 (18.4%) and 4 (1.9%) nonresponders had achieved SALT₅₀ and SALT₇₅ improvement from baseline, respectively (Figure 2A and B). By week 76, 82 (38.7%) and 56 (26.4%) nonresponders who were uptitrated to baricitinib, 4 mg, had achieved SALT₅₀ and SALT₇₅ improvement from baseline, respectively (Figure 2B and C). Clinical outcomes for scalp hair regrowth are summarized in eTables 1 through 3 in Supplement 1.

Eyebrows and Eyelashes

At week 52, a ClinRO score of 0 or 1 with a 2-point or higher improvement from baseline for eyebrows and eyelashes had been respectively achieved in 31 of 161 (19.3%) and 33 of 137 (24.1%) baricitinib, 2 mg, nonresponders who were uptitrated to the 4-mg dose (Figure 3 and eTables 4 and 5 in Supplement 1). At week 76, response rates for a ClinRO score of 0 or 1 with a 2-point or higher improvement from baseline in eyebrows and eyelashes had respectively increased to 61 of 161 (37.9%) and 56 of 137 (40.9%) (Figures 3 and eTables 4 and 5 in Supplement 1). Clinical outcomes for eyebrow and eyelash hair regrowth are summarized in eTables 4 and 5 in Supplement 1.

Figure 3. — Patients were considered nonresponders to baricitinib, 2 mg, if they had a Severity of Alopecia Tool score greater than 20 at week 52, at which time the dose was uptitrated to baricitinib, 4 mg. The proportions of patients achieving a ClinRO measure for eyebrow (A) or eyelash (B) hair loss score of 0 or 1 with a 2-point or higher improvement from baseline were measured as efficacy outcomes. Error bars indicate 95% CIs.

Subgroups

The proportion of patients achieving clinically meaningful scalp hair regrowth was similar among patients who entered the trials with severe (SALT score 50-94) or very severe (SALT score 95-100) AA, with 20 of 70 (28.6%) patients with severe AA and 35 of 142 (24.6%) patients with very severe AA achieving a SALT score of 20 or lower at week 76 (Figure 4A). When examining response among patients receiving the uptitrated dose by their baseline duration of current episode, the response in patients with episodes 4 years or longer seemed to be delayed. By week 76, a higher proportion of patients with a baseline duration of episodes shorter than 4 years (40 of 129 [31.0%]) achieved a SALT score of 20 or lower compared with patients with a baseline duration of episodes 4 years and longer (15 of 83 [18.1%]) (Figure 4B). Baseline severity and duration-of-episode subgroups by scalp hair regrowth are summarized in eTable 1 in Supplement 1.

Figure 4. — Patients were considered nonresponders to baricitinib, 2 mg, if they had a Severity of Alopecia Tool (SALT) score greater than 20 at week 52, at which time the dose was uptitrated to baricitinib, 4 mg. The proportion of patients with severe alopecia areata (SALT score 50-94) and very severe alopecia areata (SALT score 95-100) at baseline achieving a SALT score of 20 or lower (A) and the proportion of patients with an alopecia areata episode shorter than 4 years and 4 years or longer from baseline achieving a SALT score of 20 or lower (B) were measured in subgroup analyses. Error bars indicate 95% CIs.

Discussion

It is well established that responses to treatment may greatly vary among patients with AA and that some parameters are associated with negative prognosis, including the severity and the duration of the hair loss.⁵ Dose flexibility, namely the possibility to adapt the dose of a medicine based on the response to treatment, is a potential solution to overcome these challenges in clinical practice. Prior data support that patients with very severe AA benefit from initiation of therapy with the baricitinib, 4 mg, dose at baseline.⁷ To further explore the effect of doses on response to treatment, the BRAVE-AA1 and BRAVE-AA2 trials included a blinded uptitration for patients who had failed to reach a SALT score of 20 or lower after 52 weeks of treatment with baricitinib, 2 mg. As presented herein, data from the uptitration substudy suggest that uptitration may be a viable option for patients who do not achieve a successful regrowth with baricitinib, 2 mg. One in 4 nonresponders receiving baricitinib, 2 mg, achieved a SALT score of 20 or lower over the 24-week period after a dose increase to baricitinib, 4 mg. Benefits to uptitration were seen beyond the scalp. Eyebrow and eyelash hair growth also responded to dose uptitration, with an almost doubling of the proportion of patients achieving complete or nearly complete regrowth by week 76.

It is not surprising that the baricitinib, 2 mg, nonresponder group was enriched for patients with higher-severity disease, with approximately two-thirds having a baseline SALT score of 95 to 100, indicating near or complete scalp hair loss, and almost half of them being considered as alopecia universalis. By contrast, 53.2% of patients had very severe AA (SALT score 95-100) at baseline in the intent-to-treat population. The patient cohort from the uptitration substudy was biased toward having more severe and, therefore, more difficult-to-treat disease, which likely explains why we did not observe further associations of baseline severity with the response to uptitration.

Notably, the response to uptitration of dose was associated with patients’ baseline duration of current episode. A longer duration of a current AA episode appeared to slow and reduce the overall response to the dose increase compared with patients whose current episode was shorter than 4 years. Similar observations had already been made at the timing of the primary end point in the overall intent-to-treat population in the pooled studies. At week 36, patients who had current episodes of shorter than 4 years also had higher SALT score of 20 or lower response rates when treated with baricitinib compared with patients whose current episodes were 4 years or longer.⁹ However, it is more surprising to note that this effect of duration of hair loss is still observed after 52 weeks of treatment with baricitinib, 2 mg. While AA can have a fluctuating course, longer duration of a current episode is likely to reflect a more difficult-to-treat patient for whom earlier treatment with baricitinib, 4 mg, could be beneficial. This is particularly important for clinical practice, as those difficult-to-treat patients may require longer durations of treatment. In routine clinical practice, physicians may consider time points for dose escalation from 2 mg to 4 mg, based on the patient’s baseline disease characteristics, response status, and goals. While examination of the safety profile was not a part of this analysis, the safety data from 76 weeks of treatment with baricitinib has been recently published and can further inform the benefit-risk ratio for shared decision-making between the patient and physician.¹²

Limitations

In considering the clinical applicability of the study results, an important caveat is that the criteria and timing for dose uptitration were prespecified in the protocols and not individualized based on the patient’s response to treatment. In both trials, uptitration was initiated at week 52 only to allow appropriate evaluation of continuous baricitinib, 2 mg, and baricitinib, 4 mg, dosing during the first year of the trials. The criterion for uptitration was the observation of a SALT score greater than 20, irrespective of a potential improvement since enrollment. Therefore, it cannot be excluded that some patients could have reached a SALT score of 20 or lower with longer exposure to baricitinib, 2 mg. However, the slope of the SALT₇₅ response rate and the evolution of the response for eyebrows and eyelashes does suggest that uptitration was required for any patients to reach a higher level of response.

By protocol, patients were permanently discontinued at week 76 if they continued to have a SALT score higher than 20 (unless they had experienced ≥2-point improvement in ClinRO measure for eyebrow or eyelash hair loss from baseline). It is evident from the data that the slope of the response curve at week 76 had not yet plateaued, indicating that additional patients may have benefited from longer treatment.

Despite these limitations, these data have value in informing the additional benefits to hair regrowth on scalp, eyebrows, and eyelashes conferred by uptitration to baricitinib, 4 mg, in patients who do not have achieved successful regrowth with baricitinib, 2 mg. The optimal timing for uptitration should be based on the individual patient’s characteristics and the initial response to treatment.

Conclusions

In this pooled analysis of the BRAVE-AA1 and BRAVE-AA2 trials, uptitration was effective in increasing the response of scalp, eyebrow, and eyelash hair regrowth in patients who had not yet achieved at least 80% coverage of scalp after 52 weeks of therapy with baricitinib, 2 mg. Increasing the dose to baricitinib, 4 mg, allowed a larger number of patients to achieve clinically meaningful end points over the next 6 months. Uptitration for patients who fail to achieve an optimal response with baricitinib, 2 mg, is a clinically viable strategy. Both baseline severity and duration of the current episode are important disease characteristics that may affect initial response to therapy, and these data further indicate that duration may also affect the response to uptitration. These data are important for health care professionals to consider when counseling patients on treatment expectations and the potential benefits of dose escalation. Ultimately, some patients require a baricitinib, 4 mg, dose for optimal response to treatment, and these data help inform decisions around the use of uptitration in the context of nonresponse to baricitinib, 2 mg.

Supplement 1.

eTable 1. The proportion of patients achieving a Severity of Alopecia Tool (SALT) score less than or equal to 20 among Baricitinib 2 mg nonresponders (SALT Score greater than 20) at Week 52 who Uptitrated to Baricitinib 4 mg

eTable 2. The proportion of patients achieving a 50% improvement in SALT score from baseline among Baricitinib 2 mg nonresponders (Severity of Alopecia Tool (SALT) Score greater than 20) at Week 52 who Uptitrated to Baricitinib 4 mg

eTable 3. The proportion of patients achieving a 75% improvement in SALT score from baseline among Baricitinib 2 mg nonresponders (Severity of Alopecia Tool (SALT) Score greater than 20) at Week 52 who Uptitrated to Baricitinib 4 mg

eTable 4. The proportion of patients achieving a ClinRO Eyebrow Score of 0 or 1 with a ≥2-point improvement from baseline among Baricitinib 2 mg nonresponders (Severity of Alopecia Tool (SALT) Score greater than 20) at Week 52 who Uptitrated to Baricitinib 4 mg

eTable 5. The proportion of patients achieving a ClinRO Eyelash Score of 0 or 1 with a ≥2-point improvement from baseline among Baricitinib 2 mg nonresponders (Severity of Alopecia Tool (SALT) Score greater than 20) at Week 52 who Uptitrated to Baricitinib 4 mg

eTable 6. The proportion of patients achieving a Severity of Alopecia Tool (SALT) Score of less than or equal to 20 at Week 36 with a baseline duration of episode less than 4 years and greater than or equal to 4 years

eReference

Click here for additional data file.^{(326.6KB, pdf)}

Supplement 2.

Trial Protocols and Statistical Analysis Plans

Click here for additional data file.^{(32.6MB, pdf)}

Supplement 3.

Data Sharing Statement

Click here for additional data file.^{(17.5KB, pdf)}

References

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplement 1.

eReference

Click here for additional data file.^{(326.6KB, pdf)}

Supplement 2.

Trial Protocols and Statistical Analysis Plans

Click here for additional data file.^{(32.6MB, pdf)}

Supplement 3.

Data Sharing Statement

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PERMALINK

Clinical Outcomes for Uptitration of Baricitinib Therapy in Patients With Severe Alopecia Areata

Justin M Ko, MD, MBA

Tiffany T Mayo, MD

Wilma F Bergfeld, MD

Yves Dutronc, MD

Guanglei Yu, PhD

Susan G Ball, PhD

Najwa Somani, MD

Brittany G Craiglow, MD

Key Points

Question

Findings

Meaning

Abstract

Importance

Objective

Design, Setting, and Participants

Main Outcomes and Measures

Results

Conclusions and Relevance

Trial Registration

Introduction

Methods

Study Design

Figure 1. CONSORT Diagram for Patients Who Entered the BRAVE-AA1 and BRAVE-AA2 Trials.

Efficacy End Points and Subgroups

Statistical Analysis

Results

Disposition and Baseline Characteristics

Table. Baseline Demographics and Disease Measures Among Patients by Dose.

Efficacy End Points

Scalp

Figure 2. Patients Achieving a SALT Score of 20 or Lower, SALT50, and SALT75.

Eyebrows and Eyelashes

Figure 3. Patients Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrows and Eyelashes.

Subgroups

Figure 4. Patients Achieving a SALT Score of 20 or Lower After Uptitration by Disease Severity and Duration of Episode.

Discussion

Limitations

Conclusions

References

Associated Data

Supplementary Materials

ACTIONS

PERMALINK

RESOURCES

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Cited by other articles

Links to NCBI Databases

Figure 2. Patients Achieving a SALT Score of 20 or Lower, SALT₅₀, and SALT₇₅.