JAMA Dermatology

<jats:sec id="ab-doi240066-4"><jats:title>Importance</jats:title><jats:p>Isotretinoin is the only medical acne treatment capable of inducing acne remission; however, some patients experience acne relapse and require retrials of isotretinoin. There is a need to understand who is most at risk and how daily dose and cumulative dosage can influence outcomes.</jats:p></jats:sec><jats:sec id="ab-doi240066-5"><jats:title>Objective</jats:title><jats:p>To assess rates of acne relapse and isotretinoin retrial and to identify associated factors among patients with acne who received an isotretinoin treatment course.</jats:p></jats:sec><jats:sec id="ab-doi240066-6"><jats:title>Design, Setting, and Participants</jats:title><jats:p>This cohort study used data from the MarketScan commercial claims database from January 1, 2017, to December 31, 2020, to identify patients with acne who were 12 years or older and had received isotretinoin for 4 months or longer, with at least 1 year of continuous enrollment after completion of isotretinoin. Data analyses were performed from June 30, 2024, to August 1, 2024.</jats:p></jats:sec><jats:sec id="ab-doi240066-7"><jats:title>Main Outcomes and Measures</jats:title><jats:p>Multivariable Cox proportional hazards regression was used to quantify associations of patient demographic and treatment characteristics with acne relapse and isotretinoin retrial.</jats:p></jats:sec><jats:sec id="ab-doi240066-8"><jats:title>Results</jats:title><jats:p>A total of 19 907 patients (mean [SD] age, 20.6 [7.8] years; 10 504 females [52.8%]) were included, among whom 4482 (22.5%) had acne relapse and 1639 (8.2%) had isotretinoin retrial. Female sex (hazard ratio [HR], 1.43; 95% CI, 1.35-1.52) was significantly associated with increased rates of acne relapse, and isotretinoin cumulative dosage (mg/kg) was associated with a decreased rate of acne relapse (HR, 0.996; 95% CI, 0.995-0.997). Furthermore, daily dose was not associated with decreased risk of acne relapse or isotretinoin retrial among those with conventional and high cumulative dosages. Female sex (HR, 0.68; 95% CI, 0.62-0.76) and isotretinoin cumulative dosage (HR, 0.99; 95% CI, 0.98-0.99) were associated with decreased rates of isotretinoin retrial. Stratification by cumulative dosage indicated that higher cumulative dosage was associated with decreased rates of retrial among patients with low (&amp;amp;lt;120 mg/kg) and conventional (120-220 mg/kg), but not high (&amp;amp;gt;220 mg/kg) cumulative dosage. Maximum daily dose (mg/kg/d) was not negatively associated with acne relapse or isotretinoin retrial in patients with cumulative dosage of 120 mg/kg or more.</jats:p></jats:sec><jats:sec id="ab-doi240066-9"><jats:title>Conclusions and Relevance</jats:title><jats:p>The findings of this cohort study suggest that higher cumulative dosage may potentially reduce risk of acne relapse and isotretinoin retrial. Furthermore, daily dose was not associated with decreased risk of the outcomes for conventional and high cumulative dosage; therefore, daily dosing could be individualized to patient goals and preferences.</jats:p></jats:sec>

Guidelines of care for the management of acne vulgaris.

J Am Acad Dermatol

Adverse effects of isotretinoin: a retrospective review of 1743 patients started on isotretinoin.

Australas J Dermatol

Remission rates in acne patients treated with various doses of 13-cis-retinoic acid (isotretinoin).

Br J Dermatol

Isotretinoin for the treatment of acne vulgaris: which factors may predict the need for more than one course?

Isotretinoin for acne vulgaris–10 years later: a safe and successful treatment.

Recurrence rates after the first course of isotretinoin.

Arch Dermatol

Predictive factors for failure of isotretinoin treatment in acne patients: results from a cohort of 237 patients.

Dermatology

Isotretinoin in acne vulgaris: a prospective analysis of 160 cases from Kuwait.

J Drugs Dermatol

Prospective study of risk factors of relapse after treatment of acne with oral isotretinoin.

Isotretinoin therapy and the incidence of acne relapse: a nested case-control study.

Relapse of acne following isotretinoin treatment: a retrospective study of 405 patients.

The relapses of cystic acne after isotretinoin treatment are age-related: a long-term follow-up study.

Dermatologica

Low-cumulative dose isotretinoin treatment in mild-to-moderate acne: efficacy in achieving stable remission.

J Eur Acad Dermatol Venereol

Could higher doses of isotretinoin reduce the frequency of treatment failure in patients with acne?

High-dose isotretinoin treatment and the rate of retrial, relapse, and adverse effects in patients with acne vulgaris.

JAMA Dermatol

Acne relapse rate and predictors of relapse following treatment with oral isotretinoin.

Actas Dermosifiliogr

Retrospective case series of isotretinoin outcomes for acne in 393 female patients at Baylor College of Medicine during 2012-2016.

Investigation of relapse rate and factors affecting relapse after oral isotretinoin treatment in patients with acne vulgaris.

Dermatol Ther

Advantages of tailored isotretinoin treatment in moderate to severe acne: real-life data.

Front Pharmacol

Truven Health Analytics MarketScan databases for clinical research in colon and rectal surgery.

Clin Colon Rectal Surg

Big data in dermatology: publicly available health care databases for population health research.

Temporal trends in the use of systemic medications for acne from 2017 to 2020.

Anthropometric reference data for children and adults: United States, 2015-2018.

Vital Health Stat 3

Safety and efficacy of low-dose isotretinoin in the treatment of moderate to severe acne vulgaris.

Indian J Dermatol

Isotretinoin: dose, duration and relapse. What does 30 years of usage tell us?

A systematic review of isotretinoin dosing in acne vulgaris.

JEADV Clin Pract

Effectiveness of conventional, low-dose and intermittent oral isotretinoin in the treatment of acne: a randomized, controlled comparative study.

Differences in isotretinoin start, interruption, and early termination across race and sex in the iPLEDGE era.

PLoS One

The prevalence of acne in adults 20 years and older.

[Acne, hyperandrogenism and oral isotretinoin resistance. 23 cases. Therapeutic implications].

Ann Dermatol Venereol

Isotretinoin treatment in nodulocystic acne with and without polycystic ovary syndrome: efficacy and determinants of relapse.

Int J Dermatol

Acne accounts for an almost 2.5-fold higher proportion of dermatology visits among adult females compared to adult males in the United States: a study of the national ambulatory medical care survey from 2002-2016.

Making sense of the effects of the cumulative dose of isotretinoin in acne vulgaris.

Isotretinoin is the only medical acne treatment capable of inducing acne remission; however, some patients experience acne relapse and require retrials of isotretinoin. There is a need to understand who is most at risk and how daily dose and cumulative dosage can influence outcomes.
To assess rates of acne relapse and isotretinoin retrial and to identify associated factors among patients with acne who received an isotretinoin treatment course.
This cohort study used data from the MarketScan commercial claims database from January 1, 2017, to December 31, 2020, to identify patients with acne who were 12 years or older and had received isotretinoin for 4 months or longer, with at least 1 year of continuous enrollment after completion of isotretinoin. Data analyses were performed from June 30, 2024, to August 1, 2024.
Multivariable Cox proportional hazards regression was used to quantify associations of patient demographic and treatment characteristics with acne relapse and isotretinoin retrial.
A total of 19 907 patients (mean [SD] age, 20.6 [7.8] years; 10 504 females [52.8%]) were included, among whom 4482 (22.5%) had acne relapse and 1639 (8.2%) had isotretinoin retrial. Female sex (hazard ratio [HR], 1.43; 95% CI, 1.35-1.52) was significantly associated with increased rates of acne relapse, and isotretinoin cumulative dosage (mg/kg) was associated with a decreased rate of acne relapse (HR, 0.996; 95% CI, 0.995-0.997). Furthermore, daily dose was not associated with decreased risk of acne relapse or isotretinoin retrial among those with conventional and high cumulative dosages. Female sex (HR, 0.68; 95% CI, 0.62-0.76) and isotretinoin cumulative dosage (HR, 0.99; 95% CI, 0.98-0.99) were associated with decreased rates of isotretinoin retrial. Stratification by cumulative dosage indicated that higher cumulative dosage was associated with decreased rates of retrial among patients with low (<120 mg/kg) and conventional (120-220 mg/kg), but not high (>220 mg/kg) cumulative dosage. Maximum daily dose (mg/kg/d) was not negatively associated with acne relapse or isotretinoin retrial in patients with cumulative dosage of 120 mg/kg or more.
The findings of this cohort study suggest that higher cumulative dosage may potentially reduce risk of acne relapse and isotretinoin retrial. Furthermore, daily dose was not associated with decreased risk of the outcomes for conventional and high cumulative dosage; therefore, daily dosing could be individualized to patient goals and preferences.

Acne Relapse and Isotretinoin Retrial in Patients With Acne.

Acne Relapse and Isotretinoin Retrial in Patients With Acne

Journal of the American Academy of Dermatology

publisher

articletitle

journaltitle

articlelink

content_type

copyright

American Academy of Dermatology

The burden of skin disease in the United States

Magnitude and temporal trend of acne vulgaris burden in 204 countries and territories from 1990 to 2019: an analysis from the global burden of disease study 2019

Guidelines of care for the management of acne vulgaris

Evidence-based recommendations for the diagnosis and treatment of pediatric acne

Pediatrics

GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations

J Clin Epidemiol

GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength

Guideline panels should seldom make good practice statements: guidance from the GRADE Working Group

Management of acne vulgaris: a review

JAMA

The global burden of skin disease in 2010: an analysis of the prevalence and impact of skin conditions

J Invest Dermatol

Epidemiology of acne vulgaris

Global skin disease morbidity and mortality: an update from the global burden of disease study 2013

Recent findings in the epidemiologic evidence, classification, and subtypes of acne vulgaris

A qualitative investigation of the impact of acne on health-related quality of life (HRQL): development of a conceptual model

Patient perspectives on the lived experience of acne and its treatment among adult women with acne: a qualitative study

The quality of life in acne: a comparison with general medical conditions using generic questionnaires

The quality of life impact of acne and rosacea compared to other major medical conditions

Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis

Experiences of appearance-related teasing and bullying in skin diseases and their psychological sequelae: results of a qualitative study

Scand J Caring Sci

Psychosocial judgements and perceptions of adolescents with acne vulgaris: a blinded, controlled comparison of adult and peer evaluations

Biopsychosoc Med

Acne, anxiety, depression and suicide in teenagers: a cross-sectional survey of New Zealand secondary school students

J Paediatr Child Health

Systematic review of the epidemiology of acne vulgaris

Sci Rep

Prioritizing treatment outcomes: how people with acne vulgaris decide if their treatment is working

J Evid Based Med

The Leeds revised acne grading system

J Dermatol Treat

A comparison of current acne grading systems and proposal of a novel system

Development and evaluation of a global acne severity scale (GEA scale) suitable for France and Europe

Development and validation of a comprehensive acne severity scale

J Cutan Med Surg

The patient-centered acne severity scale study

Pediatr Dermatol

Development and initial validation of a multidimensional acne global grading system integrating primary lesions and secondary changes

Analysis of trends and status of physician-based evaluation methods in acne vulgaris from 2000 to 2019

J Dermatol

Evolution of acne assessments and impact on acne medications: an evolving, imperfect paradigm

Evaluation of essential clinical components and features of current acne global grading scales

Acne severity grading: determining essential clinical components and features using a Delphi consensus

A provider global assessment quality measure for clinical practice for inflammatory skin disorders

Objective assessment of acne

Clin Dermatol

Quality of life measurement in acne. Position paper of the European Academy of Dermatology and Venereology task forces on quality of life and patient oriented outcomes and acne, rosacea and hidradenitis suppurativa

Quality-of-Life research in acne vulgaris: current status and future directions

Am J Clin Dermatol

Patient-reported outcome measures for health-related quality of life in patients with acne vulgaris: a systematic review of measure development and measurement properties

Propionibacterium acnes strain populations in the human skin microbiome associated with acne

Quantitative PCR of Propionibacterium acnes DNA in samples aspirated from sebaceous follicles on the normal skin of subjects with or without acne

J Med Dent Sci

Microorganisms inhabiting follicular contents of facial acne are not only Propionibacterium but also Malassezia spp

Differences of microbiomes found in non-inflammatory and inflammatory lesions of acne vulgaris

Clin Cosmet Investig Dermatol

Skin microbiome and acne vulgaris: staphylococcus, a new actor in acne

Exp Dermatol

Inferences in microbial structural signatures of acne microbiome and mycobiome

J Microbiol

Analysis of facial skin-resident microbiota in Japanese acne patients

Nasal antibiotic-resistant Propionibacterium acnes carriage in acne vulgaris patients in Turkey

Antimicrobial susceptibility and genetic characteristics of Propionibacterium acnes isolated from patients with acne

Hormonal and metabolic aspects of acne vulgaris in women with polycystic ovary syndrome

Eur Rev Med Pharmacol Sci

Association of serum testosterone and sex hormone binding globulin levels in females with acne based on its severity

J Ayub Med Coll Abbottabad

Evaluation and treatment of hirsutism in premenopausal women: an endocrine society clinical practice guideline

J Clin Endocrinol Metab

Assessment of androgens in women with adult-onset acne

Endocrine parameters in acne vulgaris

Endocrinol Exp

Plasma androgens in women with acne vulgaris

Hormonal profiles and prevalence of polycystic ovary syndrome in women with acne

The relationship of lipid profile and menstrual cycle with acne vulgaris

Clin Biochem

Changes in the hormone and lipid profile of obese adolescent Saudi females with acne vulgaris

Braz J Med Biol Res

Role of growth hormone and insulin-like growth factor-I in hyperandrogenism and the severity of acne vulgaris in young males

Saudi Med J

Novel tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris: assessment of efficacy and safety in patients aged 9 years and older

J Drugs Dermatol JDD

Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomized, double-blind, controlled, phase III trial

Tazarotene gel is safe and effective in the treatment of acne vulgaris: a multicenter, double-blind, vehicle-controlled study

Cutis

Tazarotene 0.045% lotion for once-daily treatment of moderate-to-severe acne vulgaris: results from two phase 3 trials

Randomized phase 3 evaluation of trifarotene 50 mug/g cream treatment of moderate facial and truncal acne

Microencapsulated benzoyl peroxide and tretinoin for the treatment of acne vulgaris: results from a phase 2 multicenter, double-blind, randomized, vehicle-controlled study

Skinmed

Adapalene-benzoyl peroxide, a unique fixed-dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double-blind, controlled study in 1670 patients

Is benzoyl peroxide 3% topical gel effective and safe in the treatment of acne vulgaris in Japanese patients? A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study

Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study

Benzoyl peroxide lotion (20 percent) in acne

A double-blind study of the effectiveness of a 3% erythromycin and 5% benzoyl peroxide combination in the treatment of acne vulgaris

Treatment of acne with a combination clindamycin/benzoyl peroxide gel compared with clindamycin gel, benzoyl peroxide gel and vehicle gel: combined results of two double-blind investigations

A double-blind evaluation of topical isotretinoin 0.05%, benzoyl peroxide gel 5% and placebo in patients with acne

Clin Exp Dermatol

Efficacy and safety of clindamycin-tretinoin gel versus clindamycin or tretinoin alone in acne vulgaris: a randomized, double-blind, vehicle-controlled study

Cortexolone 17alpha-propionate 1% cream, a new potent antiandrogen for topical treatment of acne vulgaris. A pilot randomized, double-blind comparative study vs. placebo and tretinoin 0.05% cream

Tazarotene 0.045% lotion for moderate-to-severe acne in male and female participants: a phase II post-hoc analysis

J Clin Aesthet Dermatol

Tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris: impact of gender and Race on efficacy and safety

Tazarotene 0.045% lotion for moderate-to-severe acne patients: pooled phase 3 analysis by age and sex

Tretinoin 0.05% lotion for the once-daily treatment of moderate and severe acne vulgaris in females: effect of age on efficacy and tolerability

Efficacy and safety of short term use of 0.1% tazarotene gel in the treatment of mild to moderate acne vulgaris: a randomized-vehicle controlled trial

J Postgrad Med Inst

Daily treatment with adapalene gel 0.1% maintains initial improvement of acne vulgaris previously treated with oral lymecycline

Eur J Dermatol

A placebo-controlled clinical trial to compare a gel containing a combination of isotretinoin (0.05%) and erythromycin (2%) with gels containing isotretinoin (0.05%) or erythromycin (2%) alone in the topical treatment of acne vulgaris

Dermatology (Basel, Switzerland)

A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a novel tazarotene 0.045% lotion and tazarotene 0.1% cream in the treatment of moderate-to-severe acne vulgaris

Efficacy of topical isotretinoin 0.05% gel in acne vulgaris: results of a multicenter, double-blind investigation

Efficacy and tolerability of a novel tretinoin 0.05% lotion for the once-daily treatment of moderate or severe acne vulgaris in adult females

Dapsone gel 5% for the treatment of acne vulgaris: safety and efficacy of long-term (1 year) treatment

Efficacy and safety of once-daily dapsone gel, 7.5% for treatment of adolescents and adults with acne vulgaris: second of two identically designed, large, multicenter, randomized, vehicle-controlled trials

Efficacy and safety of once-daily dapsone gel, 7.5% for treatment of adolescents and adults with acne vulgaris: first of two identically designed, large, multicenter, randomized, vehicle-controlled trials

BPX-01 minocycline topical gel shows promise for the treatment of moderate-tosevere inflammatory acne vulgaris

Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: a phase 3 study

Erythromycin 2 percent gel in the treatment of acne vulgaris

Topical erythromycin solution in acne: results of a multiclinic trial

Topically applied erythromycin in inflammatory acne vulgaris

An evaluation of a 2% erythromycin ointment in the topical therapy of acne vulgaris

Topical clindamycin therapy for acne vulgaris. A cooperative clinical study

Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials

A phase 2b, randomized, double-blind vehicle controlled, dose escalation study evaluating clascoterone 0.1%, 0.5%, and 1% topical cream in subjects with facial

Acne

Treatment of mild and moderate acne vulgaris with salicylic acid in an alcohol-detergent vehicle

Clinical and laboratory studies on treatment with 20% azelaic acid cream for acne

Acta Derm Venereol Suppl

Clinical studies of 20% azelaic acid cream in the treatment of acne vulgaris. Comparison with vehicle and topical tretinoin

Efficacy of topical azelaic acid gel in the treatment of mild-moderate acne vulgaris

Indian J Dermatol Venereol Leprol

Efficacy and safety of a fixed-dose clindamycin phosphate 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15% gel for moderate-to-severe acne: a randomized phase II study of the first triple-combination drug

The efficacy and tolerability of a fixed combination clindamycin (1.2%) and benzoyl peroxide (3.75%) aqueous gel in patients with facial acne vulgaris: gender as a clinically relevant outcome variable

isotretinoin: Research & Clinical Takeaways

Acne Relapse and Isotretinoin Retrial in Patients With Acne

Guidelines of care for the management of acne vulgaris

Isotretinoin and Adverse Psychiatric Effects

Risk of Suicide and Psychiatric Disorders Among Isotretinoin Users

Papers