OFFICIAL HIGHLIGHTS

American Diabetes Association

Conference summaries


Acne & rosacea

Isotretinoin for acne and rosacea

Presented by: Dr. Pedro Mendes-Bastos Dermatology Centre, Hospital CUF Descobertas, Lisbon, Portugal
  • It is likely that less rigorous laboratory is needed and that the previously reported psychological risks may not be strictly related to isotretinoin therapy.
  • There is no evidence to support poor outcomes of surgical/cosmetic procedures during isotretinoin therapy except for mechanical dermabrasion and ablative lasers.
  • It is likely that there is no impact of isotretinoin on the onset of IBD, while early results suggest that low-dose isotretinoin is effective in papulopustular rosacea.

Isotretinoin has revolutionised treatment of acne, with new studies showing evidence of excellent clinical outcomes in treating rosacea. After decades of clinical experience, new insights are still being gained into dosing strategies, prevention of recurrence and dose-related side effects.

  • Some of the major concerns during treatment with isotretinoin include hypertriglyceridaemia, liver enzyme elevation, leukopenia and thrombocytopenia; in brief, recent studies do not support monthly testing.
  • According to the most recent recommendations, complete blood counts should be eliminated and a lipid panel and liver function should be assessed at baseline and after achieving peak dose.
  • No further monitoring is warranted if these parameters are normal. [1]
  • This guidance is confirmed by the results of a recent study in over 1800 patients in routine practice in which grade 3 or greater triglyceride and liver function testing abnormalities were noted in fewer than 1% and 0.5% of patients screened, respectively, and no grade 3 or greater cholesterol or complete blood count abnormalities were observed. [2]
  • Moreover, there were no meaningful changes in the frequency of laboratory monitoring over time.
  • A decrease in testing is also highly relevant in an era of high-value, cost-conscious care.
  • Although no causal link between isotretinoin and psychiatric adverse effects has been established, widespread media reporting of depression and suicidality with use of isotretinoin have raised concerns in both patients and clinicians and generated numerous cases of costly litigation.
  • Between 1997 and 2017, 17,829 psychiatric adverse events with isotretinoin use were submitted to the US FDA, with depressive disorders, emotional lability and anxiety disorders reported most frequently. [3]
  • However, these reports must be considered in the context of elevated rates of depression and suicide among patients with acne at large.
  • In fact, recent data suggest that the rate of completed suicide in patients taking isotretinoin may be lower than that of the general US population.
  • Many psychiatric adverse events unrelated to depression and suicidality were also reported, but it is unclear if they were a result of isotretinoin therapy.
  • At present, no causal link between isotretinoin and psychiatric risk has been established, even if patients taking the drug appear vulnerable to psychiatric concerns.
  • Similar results were reported in a nationwide cohort study involving over 440,000 patients taking isotretinoin in France where, compared with the general population, a lower risk of suicide attempt was observed among patients exposed to isotretinoin and there was no evidence for a triggering effect of isotretinoin initiation on suicide attempt. [4]
  • Regarding depression, in a systematic review and meta-analysis, isotretinoin was associated with significantly improved depressive symptoms. [5]
  • The conflicting results may be explained as isotretinoin was associated with an increased risk for depression on pooling retrospective studies, while this significant difference was not observed upon pooling prospective studies.
  • In fact, isotretinoin has been shown to improve quality of life, social anxiety and obsessive-compulsive disorder symptoms in acne patients. [6]
  • There is a widespread notion that systemic isotretinoin taken within 6 to 12 months of cutaneous surgery contributes to abnormal scarring or delayed wound healing.
  • However, this idea is recently being challenged.
  • In a systematic review on 32 relevant publications and 1485 procedures, there was insufficient evidence to support delaying manual dermabrasion, superficial chemical peels, cutaneous surgery, laser hair removal, and fractional ablative and non-ablative laser procedures for patients currently receiving or having recently completed isotretinoin therapy. [7]
  • The American Society for Dermatologic Surgery recently issued consensus recommendations regarding the safety of lasers, dermabrasion, chemical peels, energy devices and skin surgery during and after isotretinoin use, stating that there is insufficient evidence to justify delaying treatment with superficial chemical peels and nonablative lasers, including hair removal lasers and lights, vascular lasers, and nonablative fractional devices for patients currently or recently exposed to isotretinoin. [8]
  • Over the years, patients have experienced cases of IBD that appeared to be temporally associated with isotretinoin use even though a causal relationship has not been demonstrated. [9]
  • Following a number of legal litigations and additional studies, at present there appears to be no increased risk of developing IBD following isotretinoin exposure.
  • Oral isotretinoin has been associated with somewhat conflicting evidence in the treatment of papulopustular rosacea.
  • New data from randomised trials is now indicating that isotretinoin is associated with significant reduction in papules and pustules (in one study by 90%), although relapse is seen in about 50% of patients. [10]
  • Considering this, further studies are needed on the value of a minimal effective isotretinoin dose to maintain these remissions.
  • A small retrospective review of 52 patients reported that very low-dose isotretinoin (e.g., 10-20 mg once to five times a week, equivalent to 5 mg/day) is an effective treatment for mild to moderate papulopustular rosacea and is well tolerated. [11]
  • Greater personalisation of laboratory monitoring is needed during therapy with isotretinoin.
  • The psychological risks previously reported with isotretinoin may be related to acne per se, and not to isotretinoin.
  • There is no evidence to support poor outcomes of surgical/cosmetic procedures during isotretinoin therapy except for mechanical dermabrasion and ablative lasers.
  • There is likely no impact of isotretinoin on the onset of IBD.
  • New evidence suggests that low-dose isotretinoin is effective in difficult to treat papulopustular rosacea.

Key messages/Clinical perspectives

  • Some of the common notions about isotretinoin in the treatment of acne are being revisited, and some of the limitations previously perceived about the drug are being contested in the light of recent evidence.


References

References


  1. Hansen TJ, Lucking S, Miller JJ, et al. Standardized laboratory monitoring with use of isotretinoin in acne. J Am Acad Dermatol. 2016 Aug;75(2):323-8.
  2. Barbieri JS, Shin DB, Wang S, et al. The clinical utility of laboratory monitoring during isotretinoin therapy for acne and changes to monitoring practices over time. J Am Acad Dermatol. 2019 Jun 19. pii: S0190-9622(19)30989-2.
  3. Singer S, Tkachenko E, Sharma P, et al. Psychiatric adverse events in patients taking isotretinoin as reported in a Food and Drug Administration database from 1997 to 2017. JAMA Dermatol. 2019 Jul 3. doi: 10.1001/jamadermatol.2019.1416.
  4. Droitcourt C, Nowak E, Rault C, et al. Risk of suicide attempt associated with isotretinoin: a nationwide cohort and nested case-time-control study. Int J Epidemiol. 2019 May 16. pii: dyz093. doi: 10.1093/ije/dyz093.
  5. Li C, Chen J, Wang W, et al. Use of isotretinoin and risk of depression in patients with acne: a systematic review and meta-analysis. BMJ Open. 2019 Jan 21;9(1):e021549.
  6. Erdoğan Y, Erturan İ, Aktepe E, et al. Comparison of quality of life, depression, anxiety, suicide, social anxiety and obsessive-compulsive symptoms between adolescents with acne receiving isotretinoin and antibiotics: A prospective, non-randomised, open-label study. Paediatr Drugs. 2019 Jun;21(3):195-202.
  7. Spring LK, Krakowski AC, Alam M, et al. Isotretinoin and timing of procedural interventions: a systematic review with consensus recommendations. JAMA Dermatol. 2017 Aug 1;153(8):802-9.
  8. Waldman A, Bolotin D, Arndt KA, et al. ASDS Guidelines Task Force: consensus recommendations regarding the safety of lasers, dermabrasion, chemical peels, energy devices, and skin surgery during and after isotretinoin use. Dermatol Surg. 2017 Oct;43(10):1249-62.
  9. Etminan M1, Bird ST, Delaney JA, et al. Isotretinoin and risk for inflammatory bowel disease: a nested case-control study and meta-analysis of published and unpublished data. JAMA Dermatol. 2013 Feb;149(2):216-20.
  10. Sbidian E, Vicaut É, Chidiack H, et al. A randomized-controlled trial of oral low-dose isotretinoin for difficult-to-treat papulopustular rosacea. J Invest Dermatol. 2016 Jun;136(6):1124-9.
  11. Rademaker M. Very low-dose isotretinoin in mild to moderate papulopustular rosacea; a retrospective review of 52 patients. Australas J Dermatol. 2018 Feb;59(1):26-30.

Presenter disclosure information: PM Bastos: AbbVie, Bayer, Cantabria Labs, Janssen-Cilag, LeoPharma, L’Oreal, Novartis, Pfizer, Sanofi, Teva.

Medical writer: Patrick Moore, PhD

Reviewer: Martina Lambertini, MD

Local reviewers: Martina Lambertini, MD (Italian); Alain Brassard, MD (French); Jorge Moreno González, MD (Spanish); Swen Malte John, MD, PhD (German); Marcelo Arnone, MD (Portuguese)

Scientific Editor: Prof. Brigitte Dréno, MD


CLINICAL TRIALS

PSORIASIS

Efficacy and safety of ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis

Presented by: Prof. Kim A. Papp, Department of Medicine, Division of Dermatology, University of Toronto, Toronto, Canada

ATOPIC DERMATITIS

Efficacy and safety of baricitinib in combination with topical corticosteroids in moderate to severe atopic dermatitis: results of a phase 3 randomized, double-blind, placebo-controlled 16-week trial (BREEZE-AD7)

Presented by: Prof. Kristian Reich, Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation® Center, Hamburg, Germany

PRURIGO NODULARIS

Phase 2b study of nemolizumab in patients with moderate to severe prurigo nodularis and associated severe pruritus

Presented by: Prof. Sonja Ständer, Department of Dermatology and Center for Chronic Pruritus (KCP), University Hospital Münster, Germany

VITILIGO

Efficacy and safety of a 52-week, randomized, double-blind trial of ruxolitinib cream for the treatment of vitiligo

Presented by: Dr. Amit G. Pandya, University of Texas Southwestern Medical Center, Dallas, TX, USA
 

EMERGING TERAPIES

PSORIASIS

Emerging therapies for psoriasis

Presented by: Prof. Michel Gilliet, Department of Dermatology, Lausanne CHUV, Switzerland

ATOPIC DERMATITIS

New and emerging therapies in atopic dermatitis

Presented by: Prof. Dagmar Simon, Department of Dermatology, Inselspital, Bern University Hospital, Bern, Switzerland

ONYCHOMYCOSIS

Emerging treatments for onychomycosis

Presented by: Dr. Ditte Marie L. Saunte, Department of Dermatology, Institute for Clinical Medicine, Zealand University Hospital, Roskilde, Denmark
 

REVIEW & UPDATES

ACNE & ROSACEA

Isotretinoin for acne and rosacea

Presented by: Dr. Pedro Mendes-Bastos, Dermatology Centre, Hospital CUF Descobertas, Lisbon, Portugal

ALOPECIA AREATA

New drugs for alopecia areata

Presented by: Prof. Spyridon Gkalpakiotis, Department of Dermatovenereology, Third Faculty of Medicine and University Hospital of Kralovske Vinohrady, Prague, Czech Republic.

DERMATOSURGERY

Update in dermatosurgery

Presented by: Prof. Eduardo Nagore, Department of Dermatology, Instituto Valenciano de Oncología, Valencia, Spain

EPIDERMOLYSIS BULLOSA

New start of gene therapy in epidermolysis bullosa

Presented by: Prof. Leena K. Bruckner-Tuderman, University Medical Center, Albert-Ludwigs-University of Freiburg, Germany

MELANOMA

Treatment resistance in metastatic melanoma

Presented by: Prof. Martin Röcken, Department of Dermatology, Eberhard-Karls-University Tübingen, Germany

SCAR TREATMENT

Future of medical scar treatment

Presented by: Prof. Gabriella Fabbrocini, Department of Dermatology, University of Naples Federico II, Naples, Italy
 

EDUCATION FORUM

NON-MELANOMA SKIN CANCER

Systemic treatments of non-melanoma skin cancer

Presented by: Prof. Henrik F. Lorentzen, Department of Dermatology, Aarhus University Hospital, Denmark
 

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