antibiotics in the treatment of acne vulgaris: a guideline ... · antibiotics in the treatment of...

RESULTS & CONCLUSION

After compilation of available research on the topic, we concluded that there is systematic

misuse of antibiotics in the treatment of acne vulgaris, and call into the question their

placement in current guidelines. Furthermore, the cost to society of the disease itself is

relatively undervalued and unrecognized. We conclude that isotretinoin should be

considered sooner in treatment for the indication of moderate to severe acne vulgaris,

following topical treatment options. We also conclude that the current method of managing

the teratogenicity of isotretinoin (iPLEDGE and birth control), is flawed and requires

revision to address the significant amount of birth defects associated with its use.

OBJECTIVE

Current treatment of acne vulgaris relies heavily on systemic antimicrobial agents. The

American Academy of Dermatology recommends their use in treatment of moderate to

severe inflammatory lesions for a duration of 3 months. Antibiotics should not be used as

a monotherapy or for a duration longer than 3 months, but they frequently are. Side effects

to antimicrobial treatment persist after discontinuation. In many patients, acne is a disorder

in which symptoms typically recur over years. Consequently, identifying a sustainable

treatment regimen is an important component of acne management. Isotretinoin is

extremely efficacious and has long-term benefits after use. It has also been the source of

controversy due to its alleged and real connection to severe side effects and teratogenicity.

The purpose of this review is to evaluate the use of antibiotics and isotretinoin in the

treatment of acne vulgaris.

METHODS

We achieved our objective by performing a literature review. Sources from a variety of

medical and scholarly databases were evaluated. We determined the current role of

antibiotics in the treatment of acne vulgaris to be inappropriate, and identified isotretinoin

as an under-utilized treatment option.

Resilience of the Dominant Human Fecal Microbiota upon Short-

Course Antibiotic Challenge

◼Study Results: 1.2 % of IBD cases used isotretinoin before

IBD diagnosis, which was statistically similar to controls (1.1 %

users). This was also similar to the number of IBD patients who

used isotretinoin after a diagnosis of IBD (1.1 % ).

Disproportionate reporting by attorneys

◼Cases reported to FAERS (2003-2011) queried for IBD +

isotretinoin use.

◼2,214 cases of IBD “resulting from isotretinoin”.

▪Attorneys: 1,944 (87.8%)

▪Physicians: 132 (6.0%)

▪Consumers: 112 (5.1%)

For the entire FAERS, only 87,905 of the total 2,451,354 (3.6%)

reports for all drug reactions during the same time

period were reported by attorneys. The signal

inflation factor for IBD with isotretinoin for attorney

initiated reports was 5.82, signifying a clear distortion.

1. Reduce the use of antibiotics in the treatment

of acne.

2. Address the mental health impact

surrounding untreated acne.

3. Combat the stigma surrounding isotretinoin

and prescribe sooner in appropriate

candidates.

4. Correct the existing weaknesses within the

iPLEDGE program.

Antibiotics In The Treatment of Acne Vulgaris: A Guideline Review Ben Gardner, Grant Jerkovich, Jacob Felckowski, Breannah May, Erika Ernst

University of Iowa College of Pharmacy

Abstract

Abstract Cont.

Antimicrobial Resistance

Mental Health and Acne

Bacterial Transfer of Drug Resistant Genes

Efficaciousness and Side Effects

Litigation Related to Isotretinoin

Cost on Society

Summary of ProposalsIsotretinoin: Link to IBD?

Teratogenicity & iPLEDGE

Side effects that have an occurrence

rate >5%

dry lips, dry skin, back pain, dry eye, arthralgia,

epistaxis, headache, nasopharyngitis,

dermatitis, blood creatine kinase increased,

chelitis, musculoskeletal discomfort, upper

respiratory tract infection, visual acuity reduced

Isotretinoin therapy can result in

clinically significant lesion

reduction.

Cohort analysis shows that

Isotretinoin is a far superior agent

for cystic acne against active

comparators

Isotretinoin is a known

teratogen that causes fetal

defects including soft

tissues, cranial

abnormalities, and mental

retardation iPLEDGE is a restrictive distribution

requiring patients to use 2 forms of birth

control and monthly pregnancy tests.

With iPLEDGE, 3 out of 1000 women

still become pregnant while taking

isotretinoin. In addition to a guideline

recommendation, an update distribution

system is also needed.This was a cross-sectional,

questionnaire-based study to explore

the relationship of suicidal ideation,

mental health problems, and social

functioning to acne severity among

adolescents aged 18–19 years. The

odds ratio is comparing substantial

acne with little or no acne.

“No evidence that use of isotretinoin is associated with an increased risk for

depression, suicide, or other psychiatric disorders.”

Breakdown of Direct Costs

Above is a pie chart comparing the direct cost of

acne to the top 5 skin diseases in the US (US

dollars in billions).

Breakdown of Indirect Costs

Based on the table, patients suffer

from diagnosed depression or

psychosis before exposure to

isotretinoin or antibiotic therapy and

the number of cases actually

decreases after use of either one.

There were more cases of

depression or psychosis with use of

an antibiotic than with isotretinoin.

Similarity of volunteers from D1 to D60, n, number of subjects tested.

Relationship between antibiotic resistance and bacterial fitness.

Table: Association

between the use of

isotretinoin and

inflammatory bowel

disease (IBD) in a

population-based case–

control study in

Manitoba, Canada,

1995–2007