Alhusayen, Raed

Guilbault, Sandra

Hills, Nancy K.

Ingram, John R.

Kudlinski, Margaret V.

Lowes, Michelle A.

Marzano, Angelo V.

Naik, Haley B.

Paul, Maia

Villumsen, Bente

Williams, Jazzmin C.

Yannuzzi, Christine A.

Jazzmin C. Williams

Raed Alhusayen

Sandra Guilbault

Nancy K. Hills

John R. Ingram

Margaret V. Kudlinski

Michelle A. Lowes

Angelo V. Marzano

Maia Paul

Bente Villumsen

Christine A. Yannuzzi

Haley B. Naik

Crossref

Biologic Therapy Is Not Associated with Increased COVID-19 Severity in Patients with Hidradenitis Suppurativa: Updated Findings from the Global Hidradenitis Suppurativa COVID-19 Registry

Williams, Jazzmin C

Hills, Nancy K

Ingram, John R

Kudlinski, Margaret V

Lowes, Michelle A

Marzano, Angelo V

Yannuzzi, Christine A

Naik, Haley B

AIR Universita degli studi di Milano

Online Research @ Cardiff

Dermatology Letter  Biologic therapy is not associated with increased COVID-19 severity in patients with hidradenitis suppurativa: Updated findings from the Global Hidradenitis Suppurativa COVID-19 Registry  Jazzmin C. Williams,1 Raed Alhusayen,2 Sandra Guilbault,3 Nancy K. Hills,4 John R. Ingram,5 Margaret V. Kudlinski,1 Michelle A. Lowes,6 Angelo V. Marzano,7,8 Maia Paul,1 Bente Villumsen,9 Christine A. Yannuzzi,10 Haley B. Naik1  1Department of Dermatology, University of California San Francisco, San Francisco, CA, U.S.A; 2Dermatology Division, Department of Medicine, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada.; 3Hope for HS, Troy, MI, U.S.A.; 4Department of Neurology, Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, U.S.A.; 5Division of Infection and Immunity, Department of Dermatology & Academic Wound Healing, Cardiff University, Cardiff, U.K.; 6The Rockefeller University, New York, NY, U.S.A; 7Dermatology Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy.; 8Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy.; 9Patientforeningen HS Danmark, Copenhagen, Denmark; 10HS Warriors, Port Richey, FL, U.S.A.  Short Title: Updated findings from the Global Hidradenitis Suppurativa COVID-19 Registry  Corresponding Author: Haley B. Naik, MD, MHSc Associate Professor of Dermatology University of California, San Francisco 2340 Sutter Street, S429 San Francisco, CA 94143-0808 USA Mail Code 0808 Phone: +1 415 514 9769 Email: haley.naik@ucsf.edu  Key Message: HS patients on biologics have similar COVID-19 outcomes to those on nonbiologic therapy.  Number of Tables: 1 Number of Figures: 0 Word count: 918  Keywords: hidradenitis suppurativa; COVID-19; biologic      Dear Editor,  1  2 As the COVID-19 pandemic persists, dermatologists continue to balance the desire to achieve 3 effective hidradenitis suppurativa (HS) control through biologic therapy with the risk it may 4 pose during active COVID-19 infection in the context of comorbidities associated with severe 5 COVID-19 infection.[1] This study expands upon previous findings[1] with 188 additional 6 cases reported over 10 more months to the Global Hidradenitis Suppurativa COVID-19 7 Registry from April 5, 2020 to December 9, 2021. Registry entries were submitted by health 8 care providers (HCPs) and patients (or their caregivers, in the case of children or those too ill 9 or without capacity to complete the survey). Eligible cases had 1) an HCP-confirmed 10 diagnosis of HS and 2) an HCP-confirmed diagnosis of COVID-19 based on a positive test or 11 symptom screening questions. Data were compared based on the type of HS treatment used 12 prior to COVID-19 diagnosis: biologic vs nonbiologic. Nonbiologic treatments included 13 systemic antibiotics, anti-androgenic agents, and disease-modifying anti-rheumatic drugs. 14 Additionally, data from patients who continued biologic therapy through their COVID-19 15 diagnosis were compared to those who discontinued biologic therapy upon their COVID-19 16 diagnosis. Statistical comparisons were performed using Fisher’s exact or Pearson χ2 tests. 17 Multivariable logistic regression adjusted for age, sex, cardiovascular disease, pulmonary 18 disease, diabetes, obesity, and tobacco smoking was used to determine whether biologic use 19 predicted COVID-19 outcomes. 20  21 311 self-reported and 113 HCP-reported cases were submitted to the registry. Of the self-22 reported cases, we excluded 58 without confirmed COVID-19 diagnosis and 6 without an HS 23 diagnosis. We excluded 48 incomplete HCP-reported cases. 240 self-reported (median age: 24 33.5 years, IQR: 27-42 years, range: 13-72 years) and 65/113 HCP-reported (median age: 33 25 years, IQR: 27-42 years, range: 16-65 years) were included in the study. Additional patient 26 characteristics are described in Table 1. Tumor necrosis factor-inhibitors were the most 27 frequently reported biologic (self-reported: 33/35, 94.29%; HCP-reported: 31/36, 86.11%). 28 Systemic antibiotics were the most frequently reported nonbiologic (self-reported: 34.1% 29 (70/205); HCP-reported: 79.3% (23/29)).  30  31 Among self-reported cases, there was no difference in odds of hospitalization (biologic: 32 22.86% (8/35); nonbiologic: 17.56% (36/205), adjusted odds ratio (aOR) 0.93, 95% CI 0.36-33 2.40, P=0.89) or required respiratory support (biologic: 31.43% (11/35); nonbiologic: 24.88% 34 (51/205), aOR 0.99, 95% CI 0.42-2.29, P=0.97) based on biologic use. No differences were 35 observed in COVID-19 treatments (P>0.2 for all) or COVID-19 duration (biologic: mean 36 [standard deviation] 21.70 [12.31] days; nonbiologic: 23.45 [26.22] days, P=0.13) between 37 groups. Patients treated with biologics more frequently reported HS exacerbations with 38 COVID-19 infection (biologic: 51.43% (18/35); nonbiologic: 25.37% (52/205), P<0.01). 39 Subgroup analysis revealed no association between disease severity and HS exacerbation 40 during COVID-19 infection among patients using biologics (mild: 19.0% (11/58); moderate-41 to-severe: 32.4% (59/182), P=0.07). Furthermore, biologic therapy was associated with HS 42 exacerbation during COVID-19 infection among patients with moderate-to-severe HS 43 (biologic: 54.8% (17/31); nonbiologic: 26.5% (40/151), P<0.01). No other differences in 44 COVID-19 complications were observed between groups (P>0.1 for all). One case each of 45 sepsis and myocardial infarction were reported in patients not treated with biologics. No 46 cases of stroke or death were reported. There were no differences in hospitalization rates 47 (P=0.61), respiratory support requirement (P=0.20), or complication rates (P>0.05 for all)—48 including HS flares (P=0.30), between those who remained on versus discontinued biologics 49 upon COVID-19 diagnosis. 50  51 Among HCP-reported cases, 90.0% (54/60) had mild or asymptomatic COVID-19 infection, 52 and no association was found between COVID-19 severity and use of biologic therapy (aOR 53 3.08, 95% CI 0.26-36.6, P=0.37). No differences in COVID-19 complication rates (P=0.55) 54 or treatment type were observed (P=0.48). Like self-reported cases, there was no association 55 between COVID-19 severity and continued use or discontinuation of biologic therapy with 56 COVID-19 infection (P=0.63).  57  58 Here, we report the most recent data from the Global Hidradenitis Suppurativa COVID-19 59 Registry, which further demonstrate that HS patients on biologics do not have higher odds of 60 hospitalization or required respiratory support compared to those on nonbiologic therapies. 61 Although previous studies of smaller HS cohorts have reported similar findings,[1,2] the 62 findings from this report, which includes 126 cases (105 self/caregiver-reported and 21 HCP-63 reported) that were reported after the introduction of COVID-19 vaccines, are notable given 64 that anti-TNF therapy is associated with faster declines in COVID-19 vaccine-induced 65 neutralizing antibodies in patients with chronic inflammatory diseases.[3]  66  67 Despite growing evidence that biologic use does not increase risk of severe COVID-19 68 outcomes, patients with immune-mediated diseases frequently experience interruptions in 69 biologic treatment. In this study, 17/35 patients on biologics reported discontinuing therapy 70 upon COVID-19 diagnosis. Similarly, a global registry of 374 psoriasis patients with 71 confirmed or suspected COVID-19 reported biologic discontinuation in 51.2% of patients.[4] 72 Yet, an analysis of claims data from IBM® MarketScan® Research Databases showed that of 73 787 patients with COVID-19 and comorbid immune-mediated conditions treated with 74 immunomodulating therapy, patients who did not experience interruptions in 75 immunomodulator therapy had lower odds of hospitalization compared to patients with 76 interrupted therapy (aOR 0.31, 95% [0.12-0.80], P=0.02).[5] 77  78 Limitations of this study include small sample size, recall bias, and non-response bias. Our 79 study population is notable for the underrepresentation of Black patients, a group known to 80 be disproportionately affected by both HS[6] and COVID-19.[7] For example, one study of 81 7,361 patients treated with biologics and 74,910 matched controls showed that Black patients 82 on biologics had greater risk of COVID-19 infection compared to White patients on biologics 83 (aOR 2.10, 95% CI [1.73-2.56], P<0.001).[8] Thus our findings may not be generalizable to 84 groups with high social and structural risk for increased COVID19 infection.[7]  85  86 Considering the prolonged duration of the pandemic, our findings from the largest 87 international cohort of HS patients with COVID-19 infection offer meaningful support to 88 continue biologic therapy for HS patients.  89  Statements Conflict of Interest Statement Dr Alhusayen has received fees for participating in advisory boards for AbbVie, Janssen, and Novartis; has received consulting fees from Sandoz, Merck, and Boehringer Ingelheim; and is a board member of the Canadian Hidradenitis Suppurativa Foundation. Author Ingram has received fees for participating in advisory boards for Viela Bio and Kymera Therapeutics; consulting fees from UCB Pharma, Novartis, ChemoCentryx, and Boehringer Ingelheim; editorial honorarium as BJD Editor-in-Chief; royalties as chapter author for UpToDate; and co-copyright holder for the HiSQOL, HS Patient Global Assessment, HS Investigator Global Assessment. He received travel expenses and a speaker's honorarium from UCB Pharma. His department receives income from copyright of the Dermatology Life Quality Instrument (DLQI) and related instruments. Dr Lowes has received fees for participating in advisory boards for AbbVie, Janssen, Viela Bio and consulting fees from Incyte, BSN, XBiotech, Kymera, and Almirall and is the Vice President of the US Hidradenitis Suppurativa Foundation. Author Guilbault has received compensation for patient advisory board from Boehringer Ingelheim and is a board member of the US HS Foundation and Hope for HS. Author Villumsen has received consulting fees from Boehringer Ingelheim, UCB and Novartis and is the President of Patientforeningen HS Danmark and co-copyright holder for the HiSQOL, HS Patient Global Assessment, HS Investigator Global Assessment. Dr Naik has received grant support from AbbVie, consulting fees from 23andme, advisory board fees from Invitrogen Biovitrum; has served as an investigator for Pfizer; and is a board member of the US Hidradenitis Suppurativa Foundation. Dr Marzano and Authors Williams, Kudlinski, Paul, and Yannuzzi have no conflicts of interest to declare.  Funding Sources Dr. Naik is supported by the National Institutes of Health (NIAMS K23 AR074531). Study recruitment was supported by the US and Canadian Hidradenitis Suppurativa Foundation.  Author Contributions J.C.W. led manuscript writing, review, and editing, and supported formal analysis. R.A., J.R.I., M.A.L., A.V.M., and B.V. contributed a supporting role in study conceptualization, data curation, methodology, and manuscript review and editing. S.G. and C.Y. contributed a supporting role in study conceptualization, data curation, and methodology. N.H. led formal analysis. M.V.K. supported formal analysis and led data curation and project administration. M.P. supported data curation and project administration. H.B.N. led study conceptualization, methodology, funding acquisition, investigation, resources, and supervision, and supported data curation, formal analysis, project administration, and manuscript review and editing.  References 1  Naik HB, Alhusayen R, Frew J, Guilbault S, Hills NK, Ingram JR, et al. Biologic therapy is not associated with increased COVID-19 severity in patients with hidradenitis suppurativa: Initial findings from the Global Hidradenitis Suppurativa COVID-19 Registry. J Am Acad Dermatol. 2022 Jan;86(1):249–52.  2  Benesh G, Andriano TM, Babbush KM, Hosgood HD, Cohen SR. Impact of Treatment With TNF-α Inhibitors for Hidradenitis Suppurativa During the COVID-19 Pandemic. J Cutan Med Surg. 2021 Jul;25(4):446–8.  3  Geisen UM, Sümbül M, Tran F, Berner DK, Reid HM, Vullriede L, et al. Humoral protection to SARS-CoV2 declines faster in patients on TNF alpha blocking therapies. RMD Open. 2021 Dec;7(3):e002008.  4  Mahil SK, Dand N, Mason KJ, Yiu ZZN, Tsakok T, Meynell F, et al. Factors associated with adverse COVID-19 outcomes in patients with psoriasis—insights from a global registry–based study. J Allergy Clin Immunol. 2021 Jan;147(1):60–71.  5  Bergman M, Saffore CD, Kim KJ, Patel PA, Garg V, Xuan S, et al. Healthcare Resource Use in Patients with Immune-Mediated Conditions Treated with Targeted Immunomodulators During COVID-19 Pandemic: A Retrospective Claims Analysis. Adv Ther. 2021;38(10):5302–16.  6  Sachdeva M, Shah M, Alavi A. Race-Specific Prevalence of Hidradenitis Suppurativa. J Cutan Med Surg. 2020 Nov;1203475420972348.  7  Franz B, Parker B, Milner A, Braddock JH. The Relationship between Systemic Racism, Residential Segregation, and Racial/Ethnic Disparities in COVID-19 Deaths in the United States. Ethn Dis. 2022;32(1):31–8.  8  Pahalyants V, Murphy WS, Klebanov N, Lu C, Theodosakis N, Klevens RM, et al. Immunosuppressive biologics did not increase the risk of COVID-19 or subsequent mortality: A retrospective matched cohort study from Massachusetts. J Am Acad Dermatol. 2022 Jan;86(1):252–5.  Table 1 Patient Characteristics  Patient/Caregiver-reported cases Health care provider-reported cases Characteristics Biologic No Biologic All Biologic No Biologic All Number  35 205 240 36 29 65 Age, y (median, IQR) 38 (32-46) 34 (26-41) 35 (27-42) 34 (25-42) 36 (28-42) 35 (27-42) Female sex, n (%) 32 (91.4) 186 (90.7) 218 (90.8) 21 (58.3) 19 (67.9) 40 (62.5) Race/ethnicity, n (%)  White 22 (62.9) 146 (71.2) 168 (70.0) 16 (44.4) 11 (37.9) 27 (41.5)  Black, African  4 (11.4) 2 (1.0) 6 (2.5) 2 (5.6) 6 (20.7) 8 (12.3)  Black, Afro-Caribbean 0 (0.0) 3 (1.46) 3 (1.25) 1 (2.8) 1 (3.5) 2 (3.1)  Black, African American 2 (5.7) 6 (2.9) 8 (3.3) 6 (16.7) 1 (3.5) 7 (10.8)  Asian 0 (0.0) 2 (1.0) 2 (0.8) 3 (8.3) 1 (3.5) 4 (6.2)  Hispanic 3 (8.6) 21 (10.2) 24 (10.0) 3 (8.3) 1 (3.5) 4 (6.2)  Mixed race 4 (11.4) 17 (8.3) 21 (8.75) 0 (0.0) 2 (6.9) 2 (3.1)  Other 0 (0.0) 8 (3.9) 8 (3.3) 5 (13.9) 6 (20.7) 11 (16.9) Country, n (%)  United States 32 (91.43) 107 (52.2) 139 (57.9) 16 (44.4) 9 (31.0) 25 (38.5)  United Kingdom 1 (2.9) 16 (7.8) 17 (7.1) 5 (13.9) 4 (13.8) 9 (13.9)  Brazil 0 (0.0) 29 (14.2) 29 (12.1) 1 (2.8) 2 (6.9) 3 (4.6)  Sweden 0 (0.0) 16 (7.8) 16 (7.8) − − −  Argentina 0 (0.0) 13 (6.3) 13 (5.4) 1 (2.8) 0 (0.0) 1 (1.5)  France − − − 1 (2.8) 10 (34.5) 11 (16.9)  Italy 0 (0.0) 1 (0.5) 1 (0.4) 5 (13.9) 1 (3.5) 6 (9.2)  Other 2 23 25* 7 (19.4) 3 (10.3) 10 (15.4)† Comorbidities, n (%)  Obesity 25 (71.4) 127 (62.0) 152 (63.3) 12 (33.3) 9 (31.0) 21 (32.3)  Diabetes 4 (11.4) 11 (5.4) 15 (6.3) 5 (13.9) 2 (6.9) 7 (10.8)  Pulmonary disease 13 (37.1) 41 (20.0) 54 (22.5) 2 (5.6) 2 (6.9) 4 (6.2)  Tobacco smoking 5 (14.3) 34 (16.6) 9 (16.3) − − −  CV disease 1 (2.9) 5 (2.4) 6 (2.5) 2 (5.6) 0 (0.0) 2 (3.1) Hurley stage, n (%)  Hurley 1 − − − 3 (8.6) 5 (17.2) 8 (12.5)  Hurley 2 − − − 14 (40.0) 11 (37.9) 25 (39.1)  Hurley 3 − − − 18 (51.4) 12 (41.4%) 30 (46.9)  Unknown − − − 0 (0.0) 1 (3.5%) 1 (1.6%) CV, Cardiovascular; IQR, interquartile range. ∗ Other category includes 1-5 cases each from Austria, Belgium, Canada, Czech Republic, Denmark, Germany, Ireland, Peru, Saudi Arabia, and Spain. † Other category includes 1-5 cases each from Canada, Czech Republic, India, Israel, and Saudi Arabia.  

Biologic therapy is not associated with increased covid-19 severity in patients with hidradenitis suppurativa: updated findings from the global hidradenitis suppurativa covid-19 registry

https://orca.cardiff.ac.uk/id/eprint/155367/3/Dermatology%20HS-COVID%20Biologics%20update_final.pdf

Biologic therapy is not associated with increased covid-19 severity in patients with hidradenitis suppurativa: updated findings from the global hidradenitis suppurativa covid-19 registry

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AIR Universita degli studi di Milano

Online Research @ Cardiff