Currently Constrained, Dermatologists Are Ready for New Acne Therapies
June 2018 | Volume 17 | Issue 6 | Editorials | 686 | Copyright © June 2018
Arielle R. Nagler
The Ronald O. Perelman Department of Dermatology, New York University School of Medicine, New York, NY
Acne is the most common skin condition in the United States, affecting 50 million Americans annually. The disease
Acne is the most common skin condition in the United States, affecting 50 million Americans annually. The disease’s severity can range from mild to severe, with approximately 20% of people with acne experiencing moderate to severe disease. Acne can be associated with both physical and emotional morbidity. Nevertheless, despite the prevalence and impact of moderate to severe acne, therapeutic options for patients are limited, and options have become even more restricted with the evolution of medication regulation and acne management guidelines. The field needs new tools.While there has been an explosion in therapeutics for other skin diseases in recent years, advancements for the treatment of moderate to severe acne have been few and far between. Current treatment for moderate to severe acne primarily relies on systemic medications, including antibiotics (most commonly tetracyclines) and isotretinoin. For women, there are also the additional options of combined oral contraceptives (COC) and the off-label use of spironolactone. While COC have gained specific Food and Drug Administration (FDA) approval for acne in the last 20 years, isotretinoin is the only systemic medication specifically and primarily approved by the FDA for the treatment of acne in the last 35 years.This stands in contrast to, for example, systemic psoriasis treatments, for which there has been rapid development and approval of targeted therapies since etanercept was approved in 2004. There are now five classes of biologics, including 11 different drugs, approved for psoriasis. Many of these psoriasis drugs have impressive efficacy, creating a world in which we are talking about psoriasis clearance in the context of Psoriasis Area Severity Index (PASI) 90s and 100s.Further complicating the treatment of acne, dermatologists face barriers to prescribing the limited systemic acne therapies which are available. Isotretinoin is contraindicated in pregnancy, and since its approval in 1982, the FDA has implemented three iterations of pregnancy prevention programs. iPLEDGE, the current (and most stringent) pregnancy prevention program, is an online system that requires the registration of all parties involved in the isotretinoin distribution process (including the prescribing doctor, the pharmacist, and the patient), monthly pregnancy testing, and monthly confirmation that two forms of birth control are being used by female patients. iPLEDGE is burdensome for patients and providers, and, unsurprisingly, isotretinoin use has declined since iPLEDGE’s implementation. Although national data is limited, one study at Kaiser Permanente found that prescriptions for isotretinoin decreased by 29% in the first 2 years after iPLEDGE’s implementation.1 Moreover, an FDA special report found that by the fifth year of iPLEDGE, isotretinoin prescriptions dropped by 38% from levels prior to the implementation of pregnancy prevention programs for isotretinoin.2-4Antibiotic stewardship has also affected acne care as it has become a national and international priority. The focus on decreasing antibiotic use has led to calls to decrease the extended durations of antibiotics commonly used in treating acne. Extended antibiotic durations in acne have been associated with antimicrobial resistance, decreased responsiveness of acne to therapy, and an increased risk for pharyngitis and inflammatory bowel disease.5-7 Recent American Academy of Dermatology, Global Alliance to Improve Acne Outcomes, and European Expert Group on Oral Antibiotics and Acne guidelines recommend limiting antibiotic use to 3-6 months when possible.8-10 It has become difficult to justify extended durations of antibiotics in patients with moderate to severe acne, even when patients are doing well on antibiotic therapy.So what are we left with? While changes to iPLEDGE may alleviate some of the challenges we face in treating patients with moderate to severe acne, antibiotic stewardship serves an important public health goal and is here to stay. New drug development for patients with moderate to severe acne is the true solution. The resources dedicated to research and development of psoriasis therapies yielded a dramatic expansion in the available targeted therapies for an important dermatological disease. Acne is the most common condition we treat as dermatologists. New advancements in the treatment of acne, including the introduction of new medications are needed, as our current armamentarium is far too limited.
The authos has no conflicts of interest to declare.
- Shin J, Cheetham TC, Wong L, et al. The impact of the iPLEDGE program on isotretinoin fetal exposure in an integrated health care system. J Am Acad Dermatol 2011;65:1117-25.
- Isotretinoin Pregnancy Prevention Program Evaluation. 2004. (Accessed November 29 2017, at https://www.fda.gov/ohrms/dockets/ac/04/slides/4017S1_06_Pitts.ppt.)
- Drug Safety and Risk Management Advisory Committee, Dermatologic and Ophthalmic Drugs Advisory Committee, for iPLEDGE One Year Update. 2007. (Accessed November 29, 2017, at https://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4311b1-02-ipledge.pdf.)
- Drug Safety and Risk Management Advisory Committee, Dermatologic and Opthalmic Drugs Advisory Committee, Briefing Document for iPLEDGE. 2011. (Accessed November 29, 2017, at https://wayback.archive-it.org/7993/20170114004041/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DermatologicandOphthalmicDrugsAdvisoryCommittee/UCM281376.pdf.)
- Margolis DJ, Fanelli M, Kupperman E, et al. Association of pharyngitis with oral antibiotic use for the treatment of acne: a cross-sectional and prospective cohort study. Arch Dermatol 2012;148:326-32.
- Margolis DJ, Fanelli M, Hoffstad O, Lewis JD. Potential association between the oral tetracycline class of antimicrobials used to treat acne and inflammatory bowel disease. The American journal of gastroenterology 2010;105:2610-6.
- Eady EA, Cove JH, Holland KT, Cunliffe WJ. Erythromycin resistant propionibacteria in antibiotic treated acne patients: association with therapeutic failure. Br J Dermatol 1989;121:51-7.
- Thiboutot D, Gollnick H, Bettoli V, et al. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group. J Am Acad Dermatol 2009;60:S1-50.
- Dreno B, Bettoli V, Ochsendorf F, Layton A, Mobacken H, Degreef H. European recommendations on the use of oral antibiotics for acne. Eur J Dermatol 2004;14:391-9.
- Zaenglein AL, Pathy AL, Schlosser BJ et al. Guidelines for the management of acne vulgaris. J Am Acad Dermatol 2016; 74: 945-73.