and minocycline have been associated with bacterial dysbiosis with alterations in both the gut and the skin.20-23 In addition, some reports suggest a potential association between inflammatory bowel disease (IBD) and broad-spectrum antibiotics.23-25
Sarecycline is a narrow-spectrum tetracycline-class antibiotic; its narrow-spectrum is defined as negligible antibiotic activity against many Gram-negative and anaerobic bacteria, while retaining high activity against C. acnes and clinically relevant Gram-positive organisms such as streptococci and Staphylococcus aureus, including methicillin-resistant strains.26 Sarecycline has been shown to more selectively inhibit C. acnes and several Gram-positive bacteria with minimal activity against enteric aerobic gram-negative bacteria, such as those commonly found in the gut.11-13,26 Additionally, sarecycline is active against macrolide erythromycin-resistant C. acnes.26
Sarecycline has shown reduced potential for antibacterial resistance and is currently the only antibiotic approved for acne with a low bacterial resistance statement supported in FDAapproved prescribing information.10,26 Available microbiologic data supports that sarecycline has a low propensity to induce bacterial resistance among many specific types of bacteria, including many Gram-negative bacteria and some anaerobes, which differentiates sarecycline from other tetracycline-class antibiotics that exhibit a broader spectrum of antibiotic activity.26
To date, sarecycline is the only oral antibiotic formally studied in truncal acne in pivotal trials, although evaluation of truncal acne was not the primary objective of the phase 3 studies. In pivotal phase 3 studies, sarecycline was shown to be effective for moderate to severe facial acne, with low rates of AEs, including GI side effects.10,14 Analysis of IGA data in subjects with truncal acne enrolled in the phase 3 studies demonstrates the efficacy of sarecycline for acne affecting the chest and/or back, observed as early as 3 weeks after initiation of treatment, with continued improvement over the duration of the study. The narrower spectrum of antibiotic activity compared to other tetracyclines commonly used for acne, favorable safety and tolerability profile, convenience of once-daily administration with or without food, and decreased likelihood of antibiotic resistance based currently available data, collectively support sarecycline as an optimal choice for the oral treatment of moderate to severe acne affecting the face and/or trunk.
Sarecycline is a narrow-spectrum tetracycline-class antibiotic; its narrow-spectrum is defined as negligible antibiotic activity against many Gram-negative and anaerobic bacteria, while retaining high activity against C. acnes and clinically relevant Gram-positive organisms such as streptococci and Staphylococcus aureus, including methicillin-resistant strains.26 Sarecycline has been shown to more selectively inhibit C. acnes and several Gram-positive bacteria with minimal activity against enteric aerobic gram-negative bacteria, such as those commonly found in the gut.11-13,26 Additionally, sarecycline is active against macrolide erythromycin-resistant C. acnes.26
Sarecycline has shown reduced potential for antibacterial resistance and is currently the only antibiotic approved for acne with a low bacterial resistance statement supported in FDAapproved prescribing information.10,26 Available microbiologic data supports that sarecycline has a low propensity to induce bacterial resistance among many specific types of bacteria, including many Gram-negative bacteria and some anaerobes, which differentiates sarecycline from other tetracycline-class antibiotics that exhibit a broader spectrum of antibiotic activity.26
To date, sarecycline is the only oral antibiotic formally studied in truncal acne in pivotal trials, although evaluation of truncal acne was not the primary objective of the phase 3 studies. In pivotal phase 3 studies, sarecycline was shown to be effective for moderate to severe facial acne, with low rates of AEs, including GI side effects.10,14 Analysis of IGA data in subjects with truncal acne enrolled in the phase 3 studies demonstrates the efficacy of sarecycline for acne affecting the chest and/or back, observed as early as 3 weeks after initiation of treatment, with continued improvement over the duration of the study. The narrower spectrum of antibiotic activity compared to other tetracyclines commonly used for acne, favorable safety and tolerability profile, convenience of once-daily administration with or without food, and decreased likelihood of antibiotic resistance based currently available data, collectively support sarecycline as an optimal choice for the oral treatment of moderate to severe acne affecting the face and/or trunk.
DISCLOSURES
James Del Rosso is a consultant and/or speaker (honoraria), and/or research investigator (grants) for Almirall, BioparmX, Bausch Health (Bausch Health), EPI Health, Galderma, JEM Health, LaRoche-Posay, Leo Pharma, Mayne Pharma, Sebacia, SolGel, Sun Pharma, and Vyne Therapeutics (Foamix).
Linda Stein Gold has received honoraria and/or grants from Almirall, Bausch Health (Ortho Dermatologics), Cassiopeia, Galderma, Mayne Pharma, Sol Gel, Sun Pharma, and Vyne Therapeutics (Foamix).
Hilary Baldwin has received honoraria from Almirall, Bausch Health (Ortho Dermatologics), EPI Health, Galderma, LaRoche- Posay, Mayne Pharma, Journey and SolGel.
Julie Harper has received honoraria from Almirall, Bausch Health (Ortho Dermatologics), BiopharmX, Cassiopeia, Cutanea, Dermira, EPI Health, Galderma, LaRoche Posay, SolGel, Sun Pharma, and Vyne Therapeutics (Foamix).
Joshua Zeichner has received honoraria from Almirall, Bausch Health (Ortho Dermatologics), Cassiopea, EPI Health, Galderma, Johnson & Johnson, L’Oreal, Sun Pharma, Unilever, Vyne Therapeutics.
Sabine Obagi has no conflicts of interest to disclose.
Emmy Graber has received honoraria and/or grants from Almirall, Allergan, Hovione, Sebacia, Alcimed, WebMD, Wolters Kluwer, 3Derm, and Oakland Innovation.
Francisco Hernandez Vicentei is an employee of Almirall.
Xochitl Jimenez is Sr. Medical Science Liaison at Almirall US.
Ayman Grada is Head of R&D and Medical Affairs at Almirall US.
Linda Stein Gold has received honoraria and/or grants from Almirall, Bausch Health (Ortho Dermatologics), Cassiopeia, Galderma, Mayne Pharma, Sol Gel, Sun Pharma, and Vyne Therapeutics (Foamix).
Hilary Baldwin has received honoraria from Almirall, Bausch Health (Ortho Dermatologics), EPI Health, Galderma, LaRoche- Posay, Mayne Pharma, Journey and SolGel.
Julie Harper has received honoraria from Almirall, Bausch Health (Ortho Dermatologics), BiopharmX, Cassiopeia, Cutanea, Dermira, EPI Health, Galderma, LaRoche Posay, SolGel, Sun Pharma, and Vyne Therapeutics (Foamix).
Joshua Zeichner has received honoraria from Almirall, Bausch Health (Ortho Dermatologics), Cassiopea, EPI Health, Galderma, Johnson & Johnson, L’Oreal, Sun Pharma, Unilever, Vyne Therapeutics.
Sabine Obagi has no conflicts of interest to disclose.
Emmy Graber has received honoraria and/or grants from Almirall, Allergan, Hovione, Sebacia, Alcimed, WebMD, Wolters Kluwer, 3Derm, and Oakland Innovation.
Francisco Hernandez Vicentei is an employee of Almirall.
Xochitl Jimenez is Sr. Medical Science Liaison at Almirall US.
Ayman Grada is Head of R&D and Medical Affairs at Almirall US.
ACKNOWLEDGMENT
Editorial/manuscript preparation support was provided by
Jennifer Yang, PhD of ApotheCom, and Skin Sciences PPLC;
funding provided by Almirall, Exton, PA, USA.
REFERENCES
1. Del Rosso JQ, Bikowski JB, Baum E, et al. A closer look at truncal acne vulgaris: prevalence, severity, and clinical significance. J Drugs Dermatol. 2007;6(6): 597–600.
2. Poli F, Auffret N, Leccia MT, Claudel JP, Dréno B. Truncal acne, what do we know? J Eur Acad Dermatol Venereol. 2020;34(10):2241-2246.
3. Barbieri JS, Bhate K, Hartnett KP, Fleming-Dutra KE, Margolis DJ. Trends in oral antibiotic prescriptions in dermatology, 2008 to 2016. JAMA Dermatology. 2019;155(3):290-297.
4. Del Rosso JQ, Webster GF, Rosen T, et al. Status report from the Scientific Panel on Antibiotic Use in Dermatology of the American Acne and Rosacea Society: part 1: antibiotic prescribing patterns, sources of antibiotic exposure, antibiotic consumption and emergence of antibiotic resistance, impact of alterations in antibiotic prescribing, and clinical sequelae of antibiotic use. J Clin Aesthet Dermatol. 2016;9(4):18-24.
5. Stein Gold LF. Psychological burden of truncal acne. WebMD LLC. Published 2020. Updated 06/23/2020. Accessed 10/047/2020, 2020.
6. Hazarika N, Archana M. The psychosocial impact of acne vulgaris. Indian J Dermatol. 2016;61(5):515-520.
7. Cutanea Life Sciences I. New survery peports on acne, social media behavior and teenagers self-esteem. Cutanea Life Sciences, Inc. https:// www.multivu.com/players/English/8189451-cutanea-teen-acne-socialmedia- survey/. Published 2017. Updated 12/05/2017. Accessed 10/07/2020, 2020.
8. Acne Vulgaris:the psychosocial & psychological burden of illness. Dermatologist. 2013;21(9).
9. Del Rosso JQ, Stein-Gold L, Lynde C, Tanghetti E, Alexis AF. Truncal acne: a neglected entity. J Drugs Dermatol. 2019;18(12):205-1208.
2. Poli F, Auffret N, Leccia MT, Claudel JP, Dréno B. Truncal acne, what do we know? J Eur Acad Dermatol Venereol. 2020;34(10):2241-2246.
3. Barbieri JS, Bhate K, Hartnett KP, Fleming-Dutra KE, Margolis DJ. Trends in oral antibiotic prescriptions in dermatology, 2008 to 2016. JAMA Dermatology. 2019;155(3):290-297.
4. Del Rosso JQ, Webster GF, Rosen T, et al. Status report from the Scientific Panel on Antibiotic Use in Dermatology of the American Acne and Rosacea Society: part 1: antibiotic prescribing patterns, sources of antibiotic exposure, antibiotic consumption and emergence of antibiotic resistance, impact of alterations in antibiotic prescribing, and clinical sequelae of antibiotic use. J Clin Aesthet Dermatol. 2016;9(4):18-24.
5. Stein Gold LF. Psychological burden of truncal acne. WebMD LLC. Published 2020. Updated 06/23/2020. Accessed 10/047/2020, 2020.
6. Hazarika N, Archana M. The psychosocial impact of acne vulgaris. Indian J Dermatol. 2016;61(5):515-520.
7. Cutanea Life Sciences I. New survery peports on acne, social media behavior and teenagers self-esteem. Cutanea Life Sciences, Inc. https:// www.multivu.com/players/English/8189451-cutanea-teen-acne-socialmedia- survey/. Published 2017. Updated 12/05/2017. Accessed 10/07/2020, 2020.
8. Acne Vulgaris:the psychosocial & psychological burden of illness. Dermatologist. 2013;21(9).
9. Del Rosso JQ, Stein-Gold L, Lynde C, Tanghetti E, Alexis AF. Truncal acne: a neglected entity. J Drugs Dermatol. 2019;18(12):205-1208.
