Alopecia Areata and Dexamethasone Mini-Pulse Therapy, A Prospective Cohort: Real World Evidence and Factors Related to Successful Response
Abstract
:1. Introduction
2. Materials and Methods
2.1. Variables of Interest
2.1.1. Main Variables
- Severity of the disease:
- ○
- Severity Alopecia Tool II (SALT II) [22] was used to assess the severity of the disease. The variable was assessed during a routine clinical examination at baseline, 3, 6, 9, and 12 months, or at the last follow-up visit if the treatment was discontinued before 12 months.
- ○
- The presence of alopecia of eyebrows and eyelashes, and their recovery during dexamethasone treatment, were recorded.
- Clinical variables:
- ○
- Age of onset of the disease and evolution time of the disease at the start of the treatment were recorded. Age of onset described the age of the first episode of AA; whereas the evolution time of the disease refers to the total time between the age of onset and the age at the start of the treatment. The age of onset was classified as “early” onset (<15 years old) or “late” onset (>15 years); whereas the evolution time at the start of the treatment was classified as “early” treatment (<5 years) or “late” treatment (>5 years). The choice of cut-off points for the age of onset was made in accordance with previous reports [23,24].
- ○
- Safety variables: Include the appearance or worsening of hyperglycemia, high blood pressure, increasing weight, and any other relevant adverse event that could be related to the treatment of dexamethasone. These variables were assessed every three months during protocolized follow-up consultation.
2.1.2. Other Variables
2.2. Statistical Analysis
3. Results
3.1. Sociodemographic and Clinical Features of the Sample
3.2. Characteristics of the Treatment with Dexamethasone
3.3. Evolution of SALT Scores during Dexamethasone Treatment
3.4. SALT Reduction and Associated Factors
3.5. Safety of Mini-Pulses of Oral Dexamethasone and Associated Factors
3.5.1. Overall Side Effects, Osteopenia, and Associated Factors
3.5.2. Weight Gain-Associated Factors
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variables All Patients (n = 38) | |||||
---|---|---|---|---|---|
Socio-demographic Features | |||||
Age (years) | 32.28 (SD 16.58) | Age of onset (years) | 28.26 (SD 16.74) | ||
Sex (%) | Male: | 42.5% (17/40) | Age of onset (years) | <15 | 35% (14/40) |
Female: | 57.5% (23/40) | >15 | 65% (26/40) | ||
Age at the start of the treatment (years) | 32.28 (SD 16.57) | Evolution time of the disease (years) | 5.11 (SD 7.11) | ||
Previous Treatments | |||||
Topical corticosteroids (%) | 100% (40/40) | Topical anthralin (%) | 42.5% (17/40) | ||
Intralesional steroids (%) | 60% (24/40) | Oral corticosteroids (%) | 52.5% (21/40) | ||
Topical minoxidil (%) | 80% (32/40) | Immunosuppressive agents (%) | 17.5% (7/40) | ||
Comorbidities | |||||
Hypothyroidism (%) | 27.5% (11/40) | Type 1 diabetes mellitus (%) | 5% (2/40) | ||
Celiac disease (%) | 2.5% (1/40) | Other immunomediated diseases (%) | 12.5% (5/40) | ||
Severity of the Disease | |||||
Basal SALT score | 70.77 (SD 31.13) | Eyebrows/eyelashes involvement (%) | 56.4% (22/40) | ||
Treatment Characteristics—All patients received dexamethasone 2 days per week | |||||
Dexamethasone dose (mg/day) | 2.71 (SD 1.47) | Treatment time (months) | 12.25 (SD 8.89) | ||
Cumulative dose of dexamethasone (mg) | 260.05 (SD 197.92) | Proton-pump inhibitors co-treatment (%) | 70% (28/40) | ||
Calcium/vitamin D co-treatment (%) | 82.5% (33/40) | Oral minoxidil co-treatment (%) | 27.5% (11/40) |
Variables | “Early” Group | “Late” Group | p-Value |
---|---|---|---|
(<15 Years Old) | (>15 Years Old) | ||
Male sex (%) | 42.8% (6/14) | 42.31% (11/26) | 0.97 |
Dexamethasone dose (mg/day) | 2.19 (SD 1.44) | 3 (SD 0.28) | 0.15 |
Basal SALT score (%) | 73.92 (SD 29.75) | 69 (SD 6.41) | 0.64 |
Oral minoxidil co-treatment (%) | 14.2% (2/14) | 34.62% (9/26) | 0.17 |
Factors | SALT Reduction (3 Months) | SALT Reduction (9 Months) | ||||||
---|---|---|---|---|---|---|---|---|
Univariate Analysis | Multivariate Analysis | Univariate Analysis | Multivariate Analysis | |||||
Difference/Beta | p-Value | Beta | p-Value | Difference/Beta | p-Value | Beta | p-Value | |
Sex | Male: 6.78 (SE 6.74) | 0.28 | 8.33 (SE 4.18) (female sex) | 0.05 | Male: 25.7 (SE 10.48) | 0.63 | 4.72 (SE 6.58) | 0.48 |
Female: 16.22 (SE 5.26) | Female: 31.05 (SE 8.03) | |||||||
Age | 0.38 (SE 0.26) | 0.14 | - | - | 0.69 (SE 0.40) | 0.10 | - | - |
Age of onset | 0.41 (SE 0.24) | 0.09 | 0.67 (SE 0.27) | 0.02 | 0.85 (SE 0.36) | 0.02 | 1.06 (SE 0.46) | 0.02 |
Evolution time | −0.03 (SE 0.005) | 0.49 | - | - | −0.09 (SE 0.06) | 0.17 | - | - |
Family history | Yes: 9.16 (SE 10.4) | 0.71 | - | - | Yes: 15.40 (SE 14.55) | 0.28 | - | - |
No: 13.32 (SE 4.6) | No: 32.95 (SE 6.93) | |||||||
Basal SALT | 0.057 (SE 0.13) | 0.67 | - | - | 0.23 (SE 0.22) | 0.32 | - | - |
Hypothyroidism | Yes: 7.27 (SE 7.66) | 0.40 | −11.34 (SE 4.87) | 0.03 | Yes: 25.6 (SE 14.86) | 0.76 | −12.76 (SE 9.47) | 0.19 |
No: 14.92 (SE 4.98) | No: 30.73 (SE 7.08) | |||||||
Celiac disease | Yes: 0 (SE 25.58) | 0.61 | - | - | Yes: −2 (SE 32.66) | 0.33 | - | - |
No: 13 (SE 4.26) | No: 30.92 (SE 6.40) | |||||||
Oral minoxidil co-treatment | Yes: 18 (SE 8.05) | 0.44 | 1.85 (SE 4.51) | 0.68 | Yes: 42.50 (SE 13.20) | 0.28 | −1.26 (SE 8.46) | 0.88 |
No: 10.67 (SE 4.89) | No: 7.09 (SE 11.40) | |||||||
Dexamethasone dose | 0.10 (SE 3.09) | 0.97 | - | −6.37 (SE 5.49) | 0.25 | - | - | |
R2 | - | 0.2500 | - | 0.2507 |
Factors | Overall Side Effects | Weight Gain | ||||||
---|---|---|---|---|---|---|---|---|
Univariate Analysis | Multivariate Analysis | Univariate Analysis | Multivariate Analysis | |||||
Mean/% | p-Value | Beta | p-Value | Mean/% | p-Value | Beta | p-Value | |
Sex (%) | Male: 46.67% | 0.65 | 0.57 (SE 0.43) (male sex) | 0.20 | Male: 53.33% | 0.08 | 0.63 (SE 0.42) (male sex) | 0.13 |
Female: 39.13% | Female: 26.09% | |||||||
Age (years) | Yes: 35.09 (SD 4.02) | 0.63 | - | - | Yes: 30.82 (SE 4.27) | 0.41 | ||
No: 32.55 (SD 3.43) | No: 35.25 (SE 3.26) | |||||||
Age of onset (years) | Yes: 31.42 (SD 4.18) | 0.33 | - | - | Yes: 26.50 (SE 4.52) | 0.63 | ||
No: 25.95 (SD 3.57) | No: 29.29 (SE 3.45) | |||||||
Oral minoxidil co-treatment (%) | Yes:36.36% | 0.65 | - | - | Yes: 36.36% | 0.96 | ||
No: 44.44% | No: 37.04% | |||||||
Dexamethasone dose (mg/day) | Yes: 3.38 (SD 0.34) | 0.04 | 1.87 (SE 0.92) | 0.04 | Yes: 3.11 (SE 0.38) | 0.36 | 0.053 (SE 0.42) | 0.89 |
No: 2.42 (SD 0.29) | No: 2.66 (SE 0.29) | |||||||
Treatment duration (months) | Yes: 14.18 (SD 2.27) | 0.27 | 0.35 (SE 0.38) | 0.06 | Yes: 15.07 (SE 2.39) | 0.15 | 0.01 (SE 0.11) | 0.90 |
No: 10.81 (SD 1.93) | No: 10.58 (SE 1.83) | |||||||
Cumulative dose of dexamethasone (mg) | Yes: 321 (SD 49.29) | 0.17 | 0.01 (SE 0.008) | 0.11 | Yes: 363.43 (SE 50.31) | 0.02 | 0.004 (SE 0.005) | 0.39 |
No: 229.8 (SD 42.03) | No: 212.67 (SE 38.42) | |||||||
R2 | - | 0.2048 | 0.1666 |
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Sánchez-Díaz, M.; Montero-Vilchez, T.; Bueno-Rodriguez, A.; Molina-Leyva, A.; Arias-Santiago, S. Alopecia Areata and Dexamethasone Mini-Pulse Therapy, A Prospective Cohort: Real World Evidence and Factors Related to Successful Response. J. Clin. Med. 2022, 11, 1694. https://doi.org/10.3390/jcm11061694
Sánchez-Díaz M, Montero-Vilchez T, Bueno-Rodriguez A, Molina-Leyva A, Arias-Santiago S. Alopecia Areata and Dexamethasone Mini-Pulse Therapy, A Prospective Cohort: Real World Evidence and Factors Related to Successful Response. Journal of Clinical Medicine. 2022; 11(6):1694. https://doi.org/10.3390/jcm11061694
Chicago/Turabian StyleSánchez-Díaz, Manuel, Trinidad Montero-Vilchez, Ahinoa Bueno-Rodriguez, Alejandro Molina-Leyva, and Salvador Arias-Santiago. 2022. "Alopecia Areata and Dexamethasone Mini-Pulse Therapy, A Prospective Cohort: Real World Evidence and Factors Related to Successful Response" Journal of Clinical Medicine 11, no. 6: 1694. https://doi.org/10.3390/jcm11061694
APA StyleSánchez-Díaz, M., Montero-Vilchez, T., Bueno-Rodriguez, A., Molina-Leyva, A., & Arias-Santiago, S. (2022). Alopecia Areata and Dexamethasone Mini-Pulse Therapy, A Prospective Cohort: Real World Evidence and Factors Related to Successful Response. Journal of Clinical Medicine, 11(6), 1694. https://doi.org/10.3390/jcm11061694