Anti-Inflammatory–Dose Doxycycline Is Equally Effective in Men and Women with Rosacea

Payer Perspectives in Dermatology - Rosacea
Caroline Helwick

Doxycycline 40-mg modified-release capsules administered once daily is the first and only oral medication that is approved by the US Food and Drug Administration for papulopustular rosacea, which is characterized by persistent redness with transient bumps and pimples. A recent large, community-based trial evaluated the drug’s efficacy and its side effects according to sex, and found that approximately 75% of each sex cohort achieved treatment success after 12 weeks (Del Rosso JQ, et al. J Drugs Dermatol. 2012;11:703-707).

The modified-release doxycycline 40-mg capsule formulation is specifically referred to as “the anti-inflammatory–dose doxycycline” in peer-reviewed medical literature, because its pharmacokinetic and microbiologic profiles render it less likely to precipitate antibiotic resistance, which is a concern with oral antibiotics. The plasma concentrations achieved with this drug provide anti-inflammatory effects that are unrelated to antibiotic activity and are below those required to achieve the minimum inhibitory concentrations needed to suppress bacteria, explained James Q. Del Rosso, DO, Clinical Assistant Professor of Dermatology, University of Nevada, Las Vegas, the study’s lead investigator.

The anti-inflammatory formulation is also associated with a much lower incidence of gastrointestinal side effects compared with doxycycline 100 mg once daily, Dr Del Rosso noted.

The study was a prospective planned analysis of anti-inflammatory–dose doxycycline taken once daily for up to 12 weeks in subgroups of males and females with papulopustular rosacea from a large, open-label, multicenter, community-based study of 1421 patients. Of these, 28.5% were male and 71.5% were female; 826 patients were treated with doxycycline alone (ie, the monotherapy group).

Dr Del Rosso explained why the drug should be examined by sex. “A gap exists in that more clinical data is available in female patients compared to male patients. Overall, rosacea is reported to be more common in women than in men; however, men are more likely to develop phymatous changes, which possibly suggest that the pathophysiologic mechanisms and disease course may differ in some cases, depending on gender,” he explained. “Data on the comparative efficacy of treatment of papulopustular rosacea in men and women would be a useful addition to the literature.”

“Phymatous change” is the term for skin thickening and enlargement, usually around the nose.

Rosacea was assessed on a 5-point investigator’s global assessment (IGA) scale (0 = clear, 1 = near clear, 2 = mild, 3 = moderate, 4 = severe). Erythema was also assessed on a 5-point clinician’s erythema assessment (CEA) scale (similar scale).

Disease Severity Improved in Both Groups

In the primary results of the study, which were previously published, 12 weeks of treatment produced significant improvements in the severity of papulopustular rosacea and improvements in health-related quality of life when administered as monotherapy or when added to an ongoing topical regimen.

“The present analysis extends the findings of the trial by showing that the benefits of monotherapy with this unique capsule formulation are comparable between males and females,” Dr Del Rosso reported. “The overall proportion of patients who achieved treatment success after 12 weeks of monotherapy was 73.2% in males and 75.2% in females.”

Baseline IGA scores were higher in males; however, after 12 weeks of treatment, the severity distribution was similar for males and females (Table). The majority of patients had CEA scores that were moderate or significant at baseline and mild or none at week 12 in each group.

Table IGA (Severity) Scores in the Monotherapy Group, by Week 12a

  Males, %
(N = 235)
Females, %
(N = 591)
IGA baseline
Mild
Moderate
Severe

37
49
14

48
46
6
IGA week 12
Clear
Near Clear
Mild
Moderate
Severe

35
39
21
5
0

36
39
21
4
0

aBaseline versus 12 weeks, P <.001.
Source:Del Rosso JQ, et al. J Drugs Dermatol. 2012;11:703-707.

“The proportion of patients who achieved treatment success (IGA score of 0-1) progressively increased at every time point over the 12-week duration of the trial in both men and women,” he noted.

The analysis also showed the drug to be well tolerated in both sexes, either alone or in combination with topical therapies. The most common adverse events were gastrointestinal, which affected approximately 5% of the patients overall.

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Last modified: September 4, 2013
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