Should biologics for psoriasis be interrupted in the era of COVID-19?

Should biologics for psoriasis be interrupted in the era of COVID-19? Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID- 19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. JAM ACAD DERMATOL Research Letters 1217 VOLUME 82, NUMBER 5 Should biologics for psoriasis be and this analysis is further flawed by small numbers interrupted in the era of COVID-19? of infections and short placebo-controlled periods. Moreover, minor respiratory infections may be To the Editor: With daily media warnings of a underreported, and some infections may be reported looming pandemic, physicians are understandably doubly as upper respiratory infections and as concerned about immunosuppressive or immuno- nasopharyngitis. modulating effects that might render patients Nonetheless, these data may be used to decide receiving biologic therapies more susceptible to whether to continue biologic therapy during pan- COVID-19 infection. At this early stage, we do not demics. We do not know if biologic therapies render have specific data about susceptibility to the virus, patients more susceptible to coronavirus, but we but we have data on infectious complications for know that in the pre-coronavirus era, respiratory biologic therapies from their pivotal trials for infection rates were comparable to those with psoriasis. placebo. Conversely, discontinuation of some In Table I, we compare overall infection rates as biologics can result in loss of response when well as rates of upper respiratory infections and treatments are reintroduced or even result in the nasopharyngitis for each drug versus its placebo formation of antibodies to the discontinued bio- control based on published data from pivotal trials. 2-4 logic. All of these factors must be considered when For tumor necrosis factor blockers, during the advising patients about continuing or discontinuing placebo-controlled periods, overall infections and biologic therapies. upper respiratory infections were increased by up to 7% compared with placebo, except for etanercept, a a Mark Lebwohl, MD, Ryan Rivera-Oyola, MS, and which showed no increase. Tumor necrosis factor Dedee F. Murrell, MA, BMBCh, MD, FRCP, blockers carry a black box warning concerning FACD infection. Ustekinumab showed a small increase in overall infections but not in respiratory tract in- From the Icahn School of Medicine at Mt Sinai fections. Ustekinumab blocks interleukin (IL) 12 Hospital, New York, New York ;and St. George and IL-23; IL-12 plays an important role in fighting Hospital, University of New South Wales, Sydney, viral infections. IL-23 blockers showed increases in Australia. overall infections of up to 9%, but upper respiratory Funding sources: None. infections were increased slightly in some trials but not in others. IL-17 blockers showed increases in Disclosure: Dr Lebwohl is an employee of Mount overall infections of up to 11%, but much of that Sinai; receives research funds from AbbVie, increase could be accounted for by increases in Amgen, Eli Lilly, Janssen Research and Develop- monilial infections. Upper respiratory infections ment, LLC, Novartis, Ortho Dermatologics, were increased slightly for secukinumab, but not Sanofi-Regeneron, and UCB, Inc; and has been for ixekizumab or brodalumab. the principal investigator for numerous clinical It is difficult to extrapolate from these data to trials but has no personal financial gain. determine susceptibility to coronavirus infection, Table I. Rate of infections in available biologic agents for psoriasis, n (%) Infections, overall: Nasopharyngitis: Class Biologics biologics/placebo URTI: biologics/placebo biologics/placebo TNF Etanercept NR 51 (13)/25 (13) NR Adalimumab 235 (29)/89 (22) 59 (7)/14 (4) 73 (8)/37 (8)* ,y ,y Infliximab 125 (42)/30 (40) 135 (15)/41 (14)* 50 (5)/13 (5)* ,y ,y ,y Certolizumab 129 (36)/31 (31)* 24 (7)/5 (5)* 50 (14)/12 (12)* ,y ,y ,y IL-12/IL-23 Ustekinumab 326 (25)/150 (23)* 64 (5)/30 (5)* 105 (8)/29 (8)* IL-23 Guselkumab 191 (23)/90 (21)* 41 (5)/19 (5)* 65 (8)/33 (8)* ,y ,y Tildrakizumab NR 25 (2)/9 (3)* 120 (10)/20 (6)* Risankizumab 131 (22)/26 (13)* 28 (5)/4 (2)* NR ,y ,y ,y IL-17 Secukinumab 326 (29)/103 (18)* 36 (3)/3 (1)* 125 (11)/45 (8)* ,y ,y ,y Ixekizumab 381 (26)/74 (21)* 51 (3)/12 (3)* 119 (8)/28 (8)* ,y ,y Brodalumab NR 112 (5)/40 (6)* 157 (6)/36 (6)* IL, Interleukin; NR, not reported; TNF, tumor necrosis factor; URTI, upper respiratory tract infection. *Data were collected from 2 pivotal phase 3 trials and are reported as the mean. Combined doses are reported as the mean. 1218 Research Letters JAM ACAD DERMATOL MAY 2020 Dr Murrell is an employee of St George Hospital; isotretinoin treatment with sufficient documentation. has been an investigator/advisor for Novartis, Data was compiled from the electronic medical Sun Pharma, Janssen, and AbbVie; and is the records and analyzed by using IBM SPSS Statistics director of a clinical trial center for dermato- version 25 (Armonk, NY). The average age of our logic diseases. Dr Rivera-Oyola has no conflicts patients was 34.6 years, median age 31 years, of interest to declare. average 6 standard deviation cumulative dosage 103.83 6 52.78 mg/kg, and duration 6 standard IRB approval status: Not applicable. deviation of treatment 3.9 6 1.7 months, Accepted for publication March 11, 2020. respectively. The results showed that 95.4% of patients had a Reprints not available from the authors. positive response to treatment, with 43.3% experi- Correspondence to: Ryan Rivera-Oyola, MS, The encing 100% clearance of their lesions and 52.2% Kimberly and Eric J. Waldman Department of experiencing improvement but not complete reso- Dermatology, 5 E 98th St, 5th Floor, New York, NY lution. The most frequently reported side effect from 10029 treatment was cheilitis and xerosis (97.3%). The side effect frequencies are summarized in Table I. Two E-mail: ryan.riveraoyola@mountsinai.org patients discontinued treatment because of side effects (1 because of increased joint pain and the REFERENCES other a melasma flare while on treatment). In 1. Gee K, Guzzo C, Che Mat NF, Ma W, Kumar A. The IL-12 family addition, 5 (1.3%) patients had elevations in liver of cytokines in infection, inflammation and autoimmune disorders. Inflamm Allergy Drug Targets. 2009;8(1):40-52. enzymes or lipid panel results requiring discontinu- 2. Reich K, Ortonne JP, Gottlieb AB, et al. Successful treatment of ation of therapy. moderate to severe plaque psoriasis with the PEGylated Fab’ Oral contraceptive pills (OCPs) were used as a certolizumab pegol: results of a phase II randomized, form of contraception in 35.6% of patients. OCPs are placebo-controlled trial with a re-treatment extension. Br J a known therapeutic agent used to treat acne Dermatol. 2012;167(1):180-190. 3. Ortonne JP, Ta€ıeb A, Ormerod AD, et al. Patients with moderate- vulgaris. A  analysis revealed no difference in the to-severe psoriasis recapture clinical response during re-treatment response rates between patients on OCPs and those with etanercept. Br J Dermatol. 2009;161(5):1190-1195. on nonhormonal contraceptive methods (P ¼ .763, 4. Blauvelt A, Papp KA, Sofen H, et al. Continuous dosing versus Pearson  ¼ .540, degrees of freedom ¼ 2). interrupted therapy with ixekizumab: an integrated analysis of Limitations to our study include a lack of a two phase 3 trials in psoriasis [published correction appears in J Eur Acad Dermatol Venereol. 2017;31(10):1764]. J Eur Acad standardized grading system for acne as well as a Dermatol Venereol. 2017;31(6):1004-1013. high rate of patients lost to follow-up (24.9%). Although these patients did not return for posttreat- https://doi.org/10.1016/j.jaad.2020.03.031 ment follow-up, their last note did document their response to treatment, and these individuals were Retrospective case series of therefore included in the study. isotretinoin outcomes for acne in The high response rates demonstrated by our 393 female patients at Baylor College study match other studies, suggesting that isotreti- of Medicine during 2012-2016 noin is useful for treating acne vulgaris in both the 3,4 adolescent and adult populations (91%-97.4%). To the Editor: Adult acne vulgaris (in persons aged After isotretinoin treatment, 15.5% of patients had a $25 years) has a similar pathophysiologic mecha- relapse documented at some point, lower than what nism as teenage acne, with hormonal regulation, was seen in a previous study (47.4%). Despite the cosmetic products, and stress or genetic factors high frequency of cheilitis and xerosis, no patient contributing to its pathomechanism. There are a elected to discontinue treatment because of these wide variety of treatments for adult acne, including side effects. When combined with the low fre- isotretinoin. Interestingly, there are few randomized quency of other side effects, isotretinoin should control trials of isotretinoin compared with other be considered a well-tolerated, useful option for acne treatments. Many studies demonstrate im- physicians to consider when treating acne in adult provements in adolescent acne after isotretinoin female patients. treatment. However, we sought to examine its use- fulness in treating acne in women. We analyzed 3800 a a Joan Fernandez, BS, Brigette Lee, BS, Jay M. patient charts of female patients $25 years of age a b a Patel, BS, Emma Weiss, MD, Jiating Jiang, BS, with acne vulgaris diagnoses in the Baylor Clinic. Of a a Harry Dao, MD, and Soo Jung Kim, MD, PhD these patients, 393 met the inclusion criteria of http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of the American Academy of Dermatology Pubmed Central

Should biologics for psoriasis be interrupted in the era of COVID-19?

Journal of the American Academy of Dermatology, Volume 82 (5) – Mar 19, 2020

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Abstract

Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID- 19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. JAM ACAD DERMATOL Research Letters 1217 VOLUME 82, NUMBER 5 Should biologics for psoriasis be and this analysis is further flawed by small numbers interrupted in the era of COVID-19? of infections and short placebo-controlled periods. Moreover, minor respiratory infections may be To the Editor: With daily media warnings of a underreported, and some infections may be reported looming pandemic, physicians are understandably doubly as upper respiratory infections and as concerned about immunosuppressive or immuno- nasopharyngitis. modulating effects that might render patients Nonetheless, these data may be used to decide receiving biologic therapies more susceptible to whether to continue biologic therapy during pan- COVID-19 infection. At this early stage, we do not demics. We do not know if biologic therapies render have specific data about susceptibility to the virus, patients more susceptible to coronavirus, but we but we have data on infectious complications for know that in the pre-coronavirus era, respiratory biologic therapies from their pivotal trials for infection rates were comparable to those with psoriasis. placebo. Conversely, discontinuation of some In Table I, we compare overall infection rates as biologics can result in loss of response when well as rates of upper respiratory infections and treatments are reintroduced or even result in the nasopharyngitis for each drug versus its placebo formation of antibodies to the discontinued bio- control based on published data from pivotal trials. 2-4 logic. All of these factors must be considered when For tumor necrosis factor blockers, during the advising patients about continuing or discontinuing placebo-controlled periods, overall infections and biologic therapies. upper respiratory infections were increased by up to 7% compared with placebo, except for etanercept, a a Mark Lebwohl, MD, Ryan Rivera-Oyola, MS, and which showed no increase. Tumor necrosis factor Dedee F. Murrell, MA, BMBCh, MD, FRCP, blockers carry a black box warning concerning FACD infection. Ustekinumab showed a small increase in overall infections but not in respiratory tract in- From the Icahn School of Medicine at Mt Sinai fections. Ustekinumab blocks interleukin (IL) 12 Hospital, New York, New York ;and St. George and IL-23; IL-12 plays an important role in fighting Hospital, University of New South Wales, Sydney, viral infections. IL-23 blockers showed increases in Australia. overall infections of up to 9%, but upper respiratory Funding sources: None. infections were increased slightly in some trials but not in others. IL-17 blockers showed increases in Disclosure: Dr Lebwohl is an employee of Mount overall infections of up to 11%, but much of that Sinai; receives research funds from AbbVie, increase could be accounted for by increases in Amgen, Eli Lilly, Janssen Research and Develop- monilial infections. Upper respiratory infections ment, LLC, Novartis, Ortho Dermatologics, were increased slightly for secukinumab, but not Sanofi-Regeneron, and UCB, Inc; and has been for ixekizumab or brodalumab. the principal investigator for numerous clinical It is difficult to extrapolate from these data to trials but has no personal financial gain. determine susceptibility to coronavirus infection, Table I. Rate of infections in available biologic agents for psoriasis, n (%) Infections, overall: Nasopharyngitis: Class Biologics biologics/placebo URTI: biologics/placebo biologics/placebo TNF Etanercept NR 51 (13)/25 (13) NR Adalimumab 235 (29)/89 (22) 59 (7)/14 (4) 73 (8)/37 (8)* ,y ,y Infliximab 125 (42)/30 (40) 135 (15)/41 (14)* 50 (5)/13 (5)* ,y ,y ,y Certolizumab 129 (36)/31 (31)* 24 (7)/5 (5)* 50 (14)/12 (12)* ,y ,y ,y IL-12/IL-23 Ustekinumab 326 (25)/150 (23)* 64 (5)/30 (5)* 105 (8)/29 (8)* IL-23 Guselkumab 191 (23)/90 (21)* 41 (5)/19 (5)* 65 (8)/33 (8)* ,y ,y Tildrakizumab NR 25 (2)/9 (3)* 120 (10)/20 (6)* Risankizumab 131 (22)/26 (13)* 28 (5)/4 (2)* NR ,y ,y ,y IL-17 Secukinumab 326 (29)/103 (18)* 36 (3)/3 (1)* 125 (11)/45 (8)* ,y ,y ,y Ixekizumab 381 (26)/74 (21)* 51 (3)/12 (3)* 119 (8)/28 (8)* ,y ,y Brodalumab NR 112 (5)/40 (6)* 157 (6)/36 (6)* IL, Interleukin; NR, not reported; TNF, tumor necrosis factor; URTI, upper respiratory tract infection. *Data were collected from 2 pivotal phase 3 trials and are reported as the mean. Combined doses are reported as the mean. 1218 Research Letters JAM ACAD DERMATOL MAY 2020 Dr Murrell is an employee of St George Hospital; isotretinoin treatment with sufficient documentation. has been an investigator/advisor for Novartis, Data was compiled from the electronic medical Sun Pharma, Janssen, and AbbVie; and is the records and analyzed by using IBM SPSS Statistics director of a clinical trial center for dermato- version 25 (Armonk, NY). The average age of our logic diseases. Dr Rivera-Oyola has no conflicts patients was 34.6 years, median age 31 years, of interest to declare. average 6 standard deviation cumulative dosage 103.83 6 52.78 mg/kg, and duration 6 standard IRB approval status: Not applicable. deviation of treatment 3.9 6 1.7 months, Accepted for publication March 11, 2020. respectively. The results showed that 95.4% of patients had a Reprints not available from the authors. positive response to treatment, with 43.3% experi- Correspondence to: Ryan Rivera-Oyola, MS, The encing 100% clearance of their lesions and 52.2% Kimberly and Eric J. Waldman Department of experiencing improvement but not complete reso- Dermatology, 5 E 98th St, 5th Floor, New York, NY lution. The most frequently reported side effect from 10029 treatment was cheilitis and xerosis (97.3%). The side effect frequencies are summarized in Table I. Two E-mail: ryan.riveraoyola@mountsinai.org patients discontinued treatment because of side effects (1 because of increased joint pain and the REFERENCES other a melasma flare while on treatment). In 1. Gee K, Guzzo C, Che Mat NF, Ma W, Kumar A. The IL-12 family addition, 5 (1.3%) patients had elevations in liver of cytokines in infection, inflammation and autoimmune disorders. Inflamm Allergy Drug Targets. 2009;8(1):40-52. enzymes or lipid panel results requiring discontinu- 2. Reich K, Ortonne JP, Gottlieb AB, et al. Successful treatment of ation of therapy. moderate to severe plaque psoriasis with the PEGylated Fab’ Oral contraceptive pills (OCPs) were used as a certolizumab pegol: results of a phase II randomized, form of contraception in 35.6% of patients. OCPs are placebo-controlled trial with a re-treatment extension. Br J a known therapeutic agent used to treat acne Dermatol. 2012;167(1):180-190. 3. Ortonne JP, Ta€ıeb A, Ormerod AD, et al. Patients with moderate- vulgaris. A  analysis revealed no difference in the to-severe psoriasis recapture clinical response during re-treatment response rates between patients on OCPs and those with etanercept. Br J Dermatol. 2009;161(5):1190-1195. on nonhormonal contraceptive methods (P ¼ .763, 4. Blauvelt A, Papp KA, Sofen H, et al. Continuous dosing versus Pearson  ¼ .540, degrees of freedom ¼ 2). interrupted therapy with ixekizumab: an integrated analysis of Limitations to our study include a lack of a two phase 3 trials in psoriasis [published correction appears in J Eur Acad Dermatol Venereol. 2017;31(10):1764]. J Eur Acad standardized grading system for acne as well as a Dermatol Venereol. 2017;31(6):1004-1013. high rate of patients lost to follow-up (24.9%). Although these patients did not return for posttreat- https://doi.org/10.1016/j.jaad.2020.03.031 ment follow-up, their last note did document their response to treatment, and these individuals were Retrospective case series of therefore included in the study. isotretinoin outcomes for acne in The high response rates demonstrated by our 393 female patients at Baylor College study match other studies, suggesting that isotreti- of Medicine during 2012-2016 noin is useful for treating acne vulgaris in both the 3,4 adolescent and adult populations (91%-97.4%). To the Editor: Adult acne vulgaris (in persons aged After isotretinoin treatment, 15.5% of patients had a $25 years) has a similar pathophysiologic mecha- relapse documented at some point, lower than what nism as teenage acne, with hormonal regulation, was seen in a previous study (47.4%). Despite the cosmetic products, and stress or genetic factors high frequency of cheilitis and xerosis, no patient contributing to its pathomechanism. There are a elected to discontinue treatment because of these wide variety of treatments for adult acne, including side effects. When combined with the low fre- isotretinoin. Interestingly, there are few randomized quency of other side effects, isotretinoin should control trials of isotretinoin compared with other be considered a well-tolerated, useful option for acne treatments. Many studies demonstrate im- physicians to consider when treating acne in adult provements in adolescent acne after isotretinoin female patients. treatment. However, we sought to examine its use- fulness in treating acne in women. We analyzed 3800 a a Joan Fernandez, BS, Brigette Lee, BS, Jay M. patient charts of female patients $25 years of age a b a Patel, BS, Emma Weiss, MD, Jiating Jiang, BS, with acne vulgaris diagnoses in the Baylor Clinic. Of a a Harry Dao, MD, and Soo Jung Kim, MD, PhD these patients, 393 met the inclusion criteria of

Journal

Journal of the American Academy of DermatologyPubmed Central

Published: Mar 19, 2020

References

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