Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials

September 2018 | Volume 17 | Issue 9 | Original Article | 987 | Copyright © September 2018


Angela Moore MD,a Lawrence J. Green MD,b Suzanne Bruce MD,c Neil Sadick MD,d Eduardo Tschen MD MBA,e Philip Werschler MD FAAD FAACS,f Fran E. Cook-Bolden, MD,g Sunil S. Dhawan MD,h Douglass Forsha MD,i Michael H. Gold MD FAAD,j Scott Guenthner MD,k Steven E. Kempers MD,l Leon H. Kircik MD,m Jennifer L. Parish MD,n Marta I. Rendon MD,o Phoebe Rich MD,p Linda Stein-Gold MD,q Stephen K. Tyring MD PhD,r Robert A. Weiss MD FAAD,s Adnan Nasir MD,t Carsten Schmitz MD PhD,u* Terry I. Boodhoo MS,u Alexandre Kaoukhov MD,u,* and David R. Berk MDu

aArlington Research Center, Inc., Arlington, TX bLawrence J. Green, MD, LLC, George Washington University School of Medicine, Washington, DC cSuzanne Bruce and Associates, PA, Houston, TX dSadick Research Group, New York, NY eAcademic Dermatology Associates, Albuquerque, NM fPremier Clinical Research, Spokane, WA gSkin Specialty Dermatology, New York, NY hCenter for Dermatology Clinical Research, Inc, Fremont, CA iJordan Valley Dermatology Center, Jordan, UT jTennessee Clinical Research Center, Nashville, TN kThe Dermatology Center of Indiana, PC, Plainfield, IN lAssociated Skin Care Specialists, Fridley, MN mDermResearch, PLLC, Louisville, KY nParish Dermatology, Philadelphia, PA oRendon Center, Boca Raton, FL pOregon Dermatology and Research Center, Portland, OR qHenry Ford Health System, West Bloomfield, MI rUniversity of Texas Health Science Center, Department of Dermatology, Houston, TX sLaser Skin & Vein Institute, Hunt Valley, MD tWake Research Associates, Raleigh, NC uAllergan plc, Irvine, CA *Former employee

The patient-reported outcomes for Skindex-16 symptoms, emotion, and functioning indicate that patient quality of life improved with the use of sarecycline over 12 weeks. They are also similar to Skindex-16 outcomes in patients with moderate to severe acne who were treated with minocycline.17

Limitations

Monotherapy with oral antibiotics, as evaluated in the trials here, is not standard in clinical practice1; the concomitant use of topical treatments could augment the benefit demonstrated here. The studies did not include microbiological testing of cultures obtained from patients, which may have yielded additional valuable insights into the antibacterial activity of sarecycline and impact on the human microbiome.1 Additionally, the studies were originally designed to evaluate the effect of sarecycline on noninflammatory lesion counts from a safety standpoint; thus no lower limit on baseline noninflammatory lesion counts was established to assess changes from baseline as an efficacy measure. The studies also were not powered to evaluate the effect of sarecycline on nonfacial acne. Nevertheless, sarecycline demonstrated a statistically significant benefit for noninflammatory lesions and nonfacial acne.

CONCLUSIONS

Sarecycline is a novel, tetracycline-class antibiotic representing the first narrow-spectrum, targeted therapy for acne. Oral sarecycline 1.5 mg/kg per day was effective for improving acne severity and inflammatory and noninflammatory lesion counts, with onset of efficacy for inflammatory lesions observed as early as week 3, and onset of efficacy for absolute reduction in noninflammatory lesion count observed at week 6 for study SC1401 and at week 9 for study SC1402. A benefit was also seen for nonfacial acne at week 12. Sarecycline was well tolerated and associated with low rates of vestibular side effects, phototoxicity, and GI side effects, all of which are commonly observed with use of currently available first-line oral tetracycline-class antibiotics for moderate to severe acne.

DISCLOSURES

S. Bruce, F. E. Cook-Bolden, S. S. Dhawan, D. Forsha, M. H. Gold, L. J. Green, S. Guenthner, S. E. Kempers, L. H. Kircik, A. Moore, A. Nasir, J. L. Parish, M. I. Rendon, P. Rich, N. Sadick, L. Stein- Gold, E. Tschen, S. K. Tyring, R. A. Weiss, and W. P. Werschler are investigators for Allergan plc. T. I. Boodhoo and D. R. Berk are employees of Allergan plc, and C. Schmitz and A. Kaoukhov were employees of Allergan plc at the time the studies were conducted; all may own stock/stock options in that company.

ACKNOWLEDGMENTS

Writing and editorial assistance was provided to the authors by Peloton Advantage, Parsippany, NJ, and was funded by Allergan plc, Dublin, Ireland. All authors meet the ICMJE authorship criteria.

Funding Disclosures

This study was sponsored by Allergan plc, Dublin, Ireland. Writing and editorial assistance was provided to the authors by Peloton Advantage, Parsippany, NJ, and was funded by Allergan plc. Neither honoraria nor other form of payments were made for authorship.

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AUTHOR CORRESPONDENCE

Angela Moore MD acdermacderm@gmail.com
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