P1639 - Characteristics, Comorbidities, and Outcomes of SARS-CoV-2 Infection in Patients With Conditions Treated With Systemic Immunosuppressive Therapies: A Population-Based Study

Monday, October 25, 2021

10:30 AM – 4:15 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Presenting Author(s)

David T. Rubin, MD, FACG

University of Chicago Medicine, Inflammatory Bowel Disease Center
Chicago, IL, United States

Jeffrey R. Curtis, MD, MS, MPH¹, Xiaofeng Zhou, ², David T. Rubin, MD, FACG³, Walter Reinisch, MD, PhD⁴, Jinoos Yazdany, MD, MPH⁵, Philip C. Robinson, MBChB, PhD⁶, Yan Chen, ², Ann Madsen, ², Jamie Geier, ², Birgitta Benda, MD, PhD²
¹University of Alabama at Birmingham, Birmingham, AL; ²Pfizer Inc., New York, NY; ³University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL; ⁴Medical University of Vienna, Wien, Wien, Austria; ⁵University of California, San Francisco, San Francisco, CA; ⁶School of Clinical Medicine, Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia

Introduction: We describe the characteristics and COVID-19 clinical outcomes in this pt population, compared with the general population.

Methods: This descriptive retrospective cohort study used data from the US Optum^® deidentified COVID-19 electronic health record dataset (2007–2020). Adults with COVID-19 were stratified into 3 disease cohorts (pts with rheumatoid arthritis [RA], psoriatic arthritis [PsA], or UC who had received systemic immunosuppressive therapy) and a comparator cohort that did not meet these criteria. Incidence proportions of hospitalization, intensive care unit admission, in-hospital death, all-cause mortality, and clinical manifestations of interest were calculated. Logistic regression was used in exploratory analyses to estimate the risk of endpoints, adjusting for demographics (age, sex, race, region), and demographics plus comorbidities.

Results: This analysis (Feb 01–Dec 09, 2020) included 315,101 COVID-19 pts. The incidence of hospitalization due to COVID-19 was greatest in the RA cohort compared with the PsA, UC, and comparator cohorts (Table). Adjusting for demographics, and demographics plus comorbidities, COVID-19 pts with RA had an increased risk of hospitalization and in-hospital death, compared with the comparator cohort (Figure). Adjusting for demographics, pts with UC had an increased risk of hospitalization; after adjustment for demographics plus comorbidities, the risk was no longer statistically significant (Figure). There was no statistically significant increased risk of hospitalization among pts with PsA (Figure). The risk of hospitalization was lower in COVID-19 pts with RA receiving tumor necrosis factor inhibitors (TNFi) vs non-TNFi biologics (0.32 [0.20, 0.53]) and vs the comparator cohort (0.77 [0.51, 1.17]). Compared with the comparator cohort, the risk of hospitalization due to COVID-19 was similar between pts with RA receiving tofacitinib (1.06 [0.55, 2.05]), JAK inhibitors (1.26 [0.74, 2.16]) or csDMARDs (1.21 [1.02, 1.44]). The risk of hospitalization due to COVID-19 was greater in pts with RA receiving non-TNFi biologics vs the comparator cohort (2.33 [1.79, 3.04]). A similar analysis was not performed for the UC and PsA cohorts due to small sample sizes.

Discussion: Compared with the comparator cohort, pts with RA were at a higher risk of more severe COVID-19, and except for non-TNFi biologics, immunosuppressive therapies in general did not further increase the risk. COVID-19 outcomes in pts with UC were generally similar to the comparator cohort.

Figure: Figure. Adjusted odds ratios of each endpoint in the (A) RA cohort, (B) UC cohort, and (C) PsA cohort vs the comparator cohort. a.Covariates included in logistic regression models were age, sex, race, and region; b.Covariates included in logistic regression models were age, sex, race, region, lung disease (interstitial lung disease, asthma, and chronic obstructive pulmonary disease), VTE, hypertension, coronary artery disease, serious infections (hospitalized), cancer, diabetes, CKD or dialysis, and liver disease, except for UC, which did not include serious infections (hospitalized). Odds ratios using this model are only displayed for endpoints for which there were ≥ 30 events; c.Serious infections (hospitalized) was not included as a covariate; d.CKD/dialysis was not included as a covariate; e. VTE was not included as a covariate.
ARDS, acute respiratory distress syndrome; CI, confidence interval; CKD, chronic kidney disease; ECMO, extracorporeal membrane oxygenation; ICU, intensive care unit; PsA, psoriatic arthritis; RA, rheumatoid arthritis; UC, ulcerative colitis

	RA cohort^a (N=2,306)	PsA cohort^a (N=421)	UC cohort^a (N=811)	Comparator cohort^b (N=311,563)
Baseline demographics^c Age (yrs), median (range) Female, n (%) White, n (%)	61 (19–89) 1,795 (77.8) 1,634 (70.9)	55 (22–89) 226 (53.7) 367 (87.2)	52 (18–89) 428 (52.8) 651 (80.3)	49 (18–89) 177,732 (57.1) 218,293 (70.1)
Baseline IM therapy, n (%)^c Tofacitinib Any JAK inhibitors TNFi Non-TNFi biologic csDMARD^d Corticosteroid use^e	69 (3.0) 96 (4.2) 228 (9.9) 278 (12.1) 838 (36.3) 748 (32.4)	13 (3.1) 13 (3.1) 103 (24.5) 75 (17.8) 93 (22.1) 85 (20.2)	11 (1.4) 11 (1.4) 76 (9.4) 145 (17.9) 254 (31.3) 198 (24.4)	0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 19,651 (6.3)
Primary endpoints, n; IP (95% CI) Hospitalization ICU admission	585; 25.4 (23.6, 27.2) 135; 23.1 (19.7, 26.7)	50; 11.9 (8.9, 15.4) 9; 18.0 (8.6, 31.4)	149; 18.4 (15.8, 21.2) 23; 15.4 (10.0, 22.3)	45,712; 14.7 (14.6, 14.8) 9,353; 20.5 (20.1, 20.8)
Clinical manifestations/outcomes of interest, n; IP (95% CI) In-hospital death^f All-cause mortality^g Pneumonia^h Kidney failure^h Thrombotic event^h ARDS^h Heart failure^h Sepsis/septic shock^h Mechanical ventilation/ECMO IV immunoglobulin	93; 15.9 (13.0, 19.1) 118; 5.1 (4.3, 6.1) 519; 22.5 (20.8, 24.3) 210; 9.1 (8.0, 10.4) 108; 4.7 (3.9, 5.6) 368; 16.0 (14.5, 17.5) 205; 8.9 (7.8, 10.1) 167; 7.2 (6.2, 8.4) 70; 3.0 (2.4, 3.8) 9; 0.4 (0.2, 0.7)	8; 16.0 (7.2, 29.1) 10; 2.4 (1.1, 4.3) 54; 12.8 (9.8, 16.4) 19; 4.5 (2.7, 7.0) 11; 2.6 (1.3, 4.6) 35; 8.3 (5.9, 11.4) 18; 4.3 (2.6, 6.7) 14; 3.3 (1.8, 5.5) 5; 1.2 (0.4, 2.8) 2; 0.5 (0.1, 1.7)	17; 11.4 (6.8, 17.6) 23; 2.8 (1.8, 4.2) 110; 13.6 (11.3, 16.1) 59; 7.3 (5.6, 9.3) 24; 3.0 (1.9, 4.4) 71; 8.8 (6.9, 10.9) 39; 4.8 (3.4, 6.5) 43; 5.3 (3.9, 7.1) 19; 2.3 (1.4, 3.6) 1; 0.1 (0.0, 0.7)	5,226; 11.4 (11.1, 11.7) 7,937; 2.6 (2.5, 2.6) 41,296; 13.3 (13.1, 13.4) 15,700; 5.0 (5.0, 5.1) 6,664; 2.1 (2.1, 2.2) 26,709; 8.6 (8.5, 8.7) 9,814; 3.2 (3.1, 3.2) 11,555; 3.7 (3.6, 3.8) 4,607; 1.5 (1.4, 1.5) 595; 0.2 (0.2, 0.2)

Table: Table. Baseline Characteristics and IPs of Clinical Manifestations/Outcomes in the RA, PsA, UC, and Comparator Cohorts. a.At least 1 diagnosis of RA, PsA, or UC, and treatment with IM therapy (JAK inhibitor, TNFi, non-TNFi biologic, or csDMARD) within 2 yrs prior to SARS-CoV-2 diagnosis date; b.Absence of a diagnosis of RA, PsA, or UC, and no treatment with IM therapy within 2 yrs prior to SARS-CoV-2 diagnosis date; c.Baseline was defined as within 6 months prior to SARS-CoV-2 diagnosis date; d.csDMARDs included auranofin, aurothioglucose, azathioprine, chloroquine hydrochloride, chloroquine phosphate, cyclophosphamide, cyclosporine, gold sodium thiomalate, hydroxychloroquine sulfate, leflunomide, mercaptopurine, mesalamine, methotrexate, minocycline hydrochloride, n-acetylpenicillamine, penicillamine, primaquine, sulfasalazine, tacrolimus, and thalidomide; e.Within 90 days prior to SARS-CoV-2 diagnosis date; f.Denominator is the number of pts hospitalized within 30 days of SARS-CoV-2 diagnosis; defined as death during hospitalization; g.Within 90 days of SARS-CoV-2 diagnosis date; h.Within 30 days of SARS-CoV-2 diagnosis date.
ARDS, acute respiratory distress syndrome; CI, confidence interval; csDMARD, conventional synthetic disease-modifying antirheumatic drug; ECMO, extracorporeal membrane oxygenation; ICU, intensive care unit; IM, immunomodulatory; IP, incidence proportion; IV, intravenous; JAK, Janus kinase; N, number of pts in the cohort; n, number of pts in the specified category; PsA, psoriatic arthritis; pts, patients; RA, rheumatoid arthritis; TNFi, tumor necrosis factor inhibitor; UC, ulcerative colitis

Disclosures:
Jeffrey Curtis: AbbVie – Consultant. Amgen – Consultant, Grant/Research Support. Bristol-Myers Squibb – Consultant. CorEvitas – Consultant, Grant/Research Support. Crescendo Bio – Grant/Research Support. Eli Lilly – Consultant. Janssen – Consultant. Myriad – Consultant. Pfizer Inc – Consultant, Grant/Research Support. Roche/Genentech – Consultant. UCB – Consultant.
Xiaofeng Zhou: Pfizer Inc – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
David Rubin: AbbVie – Consultant. Allergan – Consultant. AltruBio – Consultant. Arena – Consultant. Athos Therapeutics – Consultant. Bellatrix Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant. Bristol-Myers Squibb – Consultant. Celgene/Syneos – Consultant. Connect Biopharma – Consultant. Eli Lilly – Consultant. Galen Pharma/Atlantica – Consultant. Genentech/Roche – Consultant. Gilead Sciences – Consultant. InDex Pharmaceuticals – Consultant. Ironwood Pharmaceuticals – Consultant. Iterative Scopes – Consultant. Janssen – Consultant. Materia Prima – Consultant. Pfizer Inc – Consultant. Prometheus Biosciences – Consultant. Reistone Biopharma – Consultant. Takeda – Consultant, Grant/Research Support. TECHLAB, Inc. – Consultant.
Walter Reinisch: 4SC – Consultant. Abbott – Consultant, Grant/Research Support, Other Financial or Material Support, lecture fees. AbbVie – Consultant, Grant/Research Support, Other Financial or Material Support, lecture fees. AESCA – Consultant, Grant/Research Support, Other Financial or Material Support, lecture fees. AM Pharma – Consultant. Amgen – Consultant. Aptalis – Other Financial or Material Support, lecture fees. Astellas – Consultant. AstraZeneca – Consultant. Avaxia Biologics – Consultant. Bioclinica – Consultant. Biogen Idec – Consultant. Boehringer Ingelheim – Consultant. Bristol-Myers Squibb – Consultant. Celgene – Consultant. Cellerix – Consultant. Celltrion – Consultant, Other Financial or Material Support, lecture fees. Centocor – Consultant, Grant/Research Support, Other Financial or Material Support, lecture fees. ChemoCentryx – Consultant. Covance – Consultant. Danone – Consultant, Other Financial or Material Support, lecture fees. Dr. Falk Pharma – Consultant, Grant/Research Support, Other Financial or Material Support, lecture fees. Elan – Consultant, Other Financial or Material Support, lecture fees. Ferring Pharmaceuticals – Consultant, Other Financial or Material Support, lecture fees. Galapagos – Consultant. Genentech – Consultant. Gilead Sciences – Consultant. Grünenthal – Consultant. ICON – Consultant. Immundiagnostik – Grant/Research Support, Other Financial or Material Support, lecture fees. Index Pharma – Consultant. Inova – Consultant. Janssen – Consultant. Johnson and Johnson – Consultant. Kyowa Hakko Kirin Pharma – Consultant. Lipid Therapeutics – Consultant. MedImmune – Consultant. Millennium – Consultant. Mitsubishi Tanabe Pharma – Consultant, Grant/Research Support. MSD – Consultant, Grant/Research Support, Other Financial or Material Support, lecture fees. Nestlé – Consultant. Novartis – Consultant. Ocera – Consultant. Otsuka – Consultant, Other Financial or Material Support, lecture fees. PDL – Consultant, Other Financial or Material Support, lecture fees. Pfizer Inc – Consultant. Pharmacosmos – Consultant, Other Financial or Material Support, lecture fees. Procter & Gamble – Consultant. Prometheus Laboratories – Consultant. Robarts Clinical Trials – Consultant. Schering-Plough – Consultant, Other Financial or Material Support, lecture fees. Second Genome – Consultant. SetPoint Medical – Consultant. Shire – Other Financial or Material Support, lecture fees. Takeda – Consultant, Other Financial or Material Support, lecture fees. Therakos – Consultant, Other Financial or Material Support, lecture fees. TiGenix – Consultant. UCB – Consultant. Vifor – Consultant, Other Financial or Material Support, lecture fees. Yakult – Other Financial or Material Support, lecture fees. Zyngenia – Consultant.
Jinoos Yazdany: AstraZeneca – Grant/Research Support. Eli Lilly – Consultant. Pfizer Inc – Consultant. University of California, San Francisco – Employee.
Philip Robinson: AbbVie – Speaker's Bureau, Other Financial or Material Support, personal fees. Atom Biosciences – Other Financial or Material Support, personal fees. Eli Lilly – Speaker's Bureau, Other Financial or Material Support, personal fees. Gilead Sciences – Speaker's Bureau, Other Financial or Material Support, personal fees. Janssen – Grant/Research Support, Speaker's Bureau, Other Financial or Material Support, personal fees. Novartis – Grant/Research Support, Speaker's Bureau, Other Financial or Material Support, personal fees. Pfizer Inc – Grant/Research Support, Speaker's Bureau, Other Financial or Material Support, personal fees. Roche – Speaker's Bureau, Other Financial or Material Support, personal fees. The University of Queensland – Employee. UCB – Grant/Research Support, Other Financial or Material Support, personal fees.
Yan Chen: Pfizer Inc – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Ann Madsen: Pfizer Inc – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Jamie Geier: Pfizer Inc – Other Financial or Material Support, Former Employer.
Birgitta Benda: Pfizer Inc – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Jeffrey R. Curtis, MD, MS, MPH¹, Xiaofeng Zhou, ², David T. Rubin, MD, FACG³, Walter Reinisch, MD, PhD⁴, Jinoos Yazdany, MD, MPH⁵, Philip C. Robinson, MBChB, PhD⁶, Yan Chen, ², Ann Madsen, ², Jamie Geier, ², Birgitta Benda, MD, PhD². P1639 - Characteristics, Comorbidities, and Outcomes of SARS-CoV-2 Infection in Patients With Conditions Treated With Systemic Immunosuppressive Therapies: A Population-Based Study, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.