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

This study was sponsored by Pfizer Inc. J.R. Curtis, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA; X. Zhou, PhD, Y. Chen, MD, B. Benda, MD, PhD, A. Madsen, PhD, J. Geier, PhD, Pfizer Inc, New York, New York, USA; D.T. Rubin, MD, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA; W. Reinisch, MD, Medical University of Vienna, Vienna, Austria; J. Yazdany, MD, Division of Rheumatology, Department of Medicine, University of California, San Francisco, California, USA; P.C. Robinson, MBChB, PhD, School of Clinical Medicine, Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia. JRC has received grant support from, and has been a consultant for, Pfizer Inc. DTR has received grant support from Takeda; and has received consulting fees from AbbVie, AbGenomics, Allergan Inc, Boehringer Ingelheim, BMS, Celgene Corp/Syneos, Check-Cap, Dizal Pharmaceuticals, Eli Lilly, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GSK, Ichnos Sciences S.A., Janssen, Narrow River Management, Pfizer Inc, Prometheus Laboratories, Reistone, Shire, Takeda, and Techlab Inc. WR has received grant support from Abbott, AbbVie, AESCA, Centocor, Dr. Falk Pharma, Immundiagnostik, and MSD; has received lecture fees from Abbott, AbbVie, AESCA, Aptalis, Celltrion, Centocor, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Immundiagnostik, Mitsubishi Tanabe Pharma, MSD, Otsuka, PDL, Pharmacosmos, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; and has received consulting fees from Abbott, AbbVie, AESCA, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia Biologics, Bioclinica, Biogen Idec, Boehringer Ingelheim, BMS, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Galapagos, Genentech, Gilead Sciences, Grünenthal, ICON, Index Pharma, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestlé, Novartis, Ocera, Otsuka, PDL, Pfizer Inc, Pharmacosmos, Procter & Gamble, Prometheus Laboratories, Robarts Clinical Trials, Schering-Plough, Second Genome, SetPoint Medical, Takeda, Therakos, TiGenix, UCB, Vifor, Zyngenia, and 4SC. JY has received consulting fees from AstraZeneca and Eli Lilly; and has received a research grant from AstraZeneca. PCR has received personal fees from AbbVie, Atom Biosciences, Eli Lilly, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Roche, and UCB; and has received grant support from Janssen, Novartis, Pfizer Inc, and UCB. XZ, YC, BB, and AM are employees and shareholders of Pfizer Inc. JG was formerly employed by Pfizer Inc. JRC, XZ, BB, AM, and JG contributed to the conception and design of the study. All authors contributed to the acquisition, analysis and interpretation of the data, critically revised each draft of the manuscript for intellectual content, read and gave approval of the final version submitted for publication and accept accountability for the accuracy and integrity of the work. Address correspondence to Dr. X. Zhou, Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA. Email: xiaofeng.zhou@pfizer.com. Accepted for publication October 26, 2021.

This study was sponsored by Pfizer Inc. J.R. Curtis, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA; X. Zhou, PhD, Y. Chen, MD, B. Benda, MD, PhD, A. Madsen, PhD, J. Geier, PhD, Pfizer Inc, New York, New York, USA; D.T. Rubin, MD, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA; W. Reinisch, MD, Medical University of Vienna, Vienna, Austria; J. Yazdany, MD, Division of Rheumatology, Department of Medicine, University of California, San Francisco, California, USA; P.C. Robinson, MBChB, PhD, School of Clinical Medicine, Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia. JRC has received grant support from, and has been a consultant for, Pfizer Inc. DTR has received grant support from Takeda; and has received consulting fees from AbbVie, AbGenomics, Allergan Inc, Boehringer Ingelheim, BMS, Celgene Corp/Syneos, Check-Cap, Dizal Pharmaceuticals, Eli Lilly, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GSK, Ichnos Sciences S.A., Janssen, Narrow River Management, Pfizer Inc, Prometheus Laboratories, Reistone, Shire, Takeda, and Techlab Inc. WR has received grant support from Abbott, AbbVie, AESCA, Centocor, Dr. Falk Pharma, Immundiagnostik, and MSD; has received lecture fees from Abbott, AbbVie, AESCA, Aptalis, Celltrion, Centocor, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Immundiagnostik, Mitsubishi Tanabe Pharma, MSD, Otsuka, PDL, Pharmacosmos, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; and has received consulting fees from Abbott, AbbVie, AESCA, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia Biologics, Bioclinica, Biogen Idec, Boehringer Ingelheim, BMS, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Galapagos, Genentech, Gilead Sciences, Grünenthal, ICON, Index Pharma, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestlé, Novartis, Ocera, Otsuka, PDL, Pfizer Inc, Pharmacosmos, Procter & Gamble, Prometheus Laboratories, Robarts Clinical Trials, Schering-Plough, Second Genome, SetPoint Medical, Takeda, Therakos, TiGenix, UCB, Vifor, Zyngenia, and 4SC. JY has received consulting fees from AstraZeneca and Eli Lilly; and has received a research grant from AstraZeneca. PCR has received personal fees from AbbVie, Atom Biosciences, Eli Lilly, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Roche, and UCB; and has received grant support from Janssen, Novartis, Pfizer Inc, and UCB. XZ, YC, BB, and AM are employees and shareholders of Pfizer Inc. JG was formerly employed by Pfizer Inc. JRC, XZ, BB, AM, and JG contributed to the conception and design of the study. All authors contributed to the acquisition, analysis and interpretation of the data, critically revised each draft of the manuscript for intellectual content, read and gave approval of the final version submitted for publication and accept accountability for the accuracy and integrity of the work. Address correspondence to Dr. X. Zhou, Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA. Email: xiaofeng.zhou@pfizer.com. Accepted for publication October 26, 2021.

This study was sponsored by Pfizer Inc. J.R. Curtis, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA; X. Zhou, PhD, Y. Chen, MD, B. Benda, MD, PhD, A. Madsen, PhD, J. Geier, PhD, Pfizer Inc, New York, New York, USA; D.T. Rubin, MD, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA; W. Reinisch, MD, Medical University of Vienna, Vienna, Austria; J. Yazdany, MD, Division of Rheumatology, Department of Medicine, University of California, San Francisco, California, USA; P.C. Robinson, MBChB, PhD, School of Clinical Medicine, Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia. JRC has received grant support from, and has been a consultant for, Pfizer Inc. DTR has received grant support from Takeda; and has received consulting fees from AbbVie, AbGenomics, Allergan Inc, Boehringer Ingelheim, BMS, Celgene Corp/Syneos, Check-Cap, Dizal Pharmaceuticals, Eli Lilly, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GSK, Ichnos Sciences S.A., Janssen, Narrow River Management, Pfizer Inc, Prometheus Laboratories, Reistone, Shire, Takeda, and Techlab Inc. WR has received grant support from Abbott, AbbVie, AESCA, Centocor, Dr. Falk Pharma, Immundiagnostik, and MSD; has received lecture fees from Abbott, AbbVie, AESCA, Aptalis, Celltrion, Centocor, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Immundiagnostik, Mitsubishi Tanabe Pharma, MSD, Otsuka, PDL, Pharmacosmos, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; and has received consulting fees from Abbott, AbbVie, AESCA, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia Biologics, Bioclinica, Biogen Idec, Boehringer Ingelheim, BMS, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Galapagos, Genentech, Gilead Sciences, Grünenthal, ICON, Index Pharma, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestlé, Novartis, Ocera, Otsuka, PDL, Pfizer Inc, Pharmacosmos, Procter & Gamble, Prometheus Laboratories, Robarts Clinical Trials, Schering-Plough, Second Genome, SetPoint Medical, Takeda, Therakos, TiGenix, UCB, Vifor, Zyngenia, and 4SC. JY has received consulting fees from AstraZeneca and Eli Lilly; and has received a research grant from AstraZeneca. PCR has received personal fees from AbbVie, Atom Biosciences, Eli Lilly, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Roche, and UCB; and has received grant support from Janssen, Novartis, Pfizer Inc, and UCB. XZ, YC, BB, and AM are employees and shareholders of Pfizer Inc. JG was formerly employed by Pfizer Inc. JRC, XZ, BB, AM, and JG contributed to the conception and design of the study. All authors contributed to the acquisition, analysis and interpretation of the data, critically revised each draft of the manuscript for intellectual content, read and gave approval of the final version submitted for publication and accept accountability for the accuracy and integrity of the work. Address correspondence to Dr. X. Zhou, Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA. Email: xiaofeng.zhou@pfizer.com. Accepted for publication October 26, 2021.

This study was sponsored by Pfizer Inc. J.R. Curtis, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA; X. Zhou, PhD, Y. Chen, MD, B. Benda, MD, PhD, A. Madsen, PhD, J. Geier, PhD, Pfizer Inc, New York, New York, USA; D.T. Rubin, MD, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA; W. Reinisch, MD, Medical University of Vienna, Vienna, Austria; J. Yazdany, MD, Division of Rheumatology, Department of Medicine, University of California, San Francisco, California, USA; P.C. Robinson, MBChB, PhD, School of Clinical Medicine, Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia. JRC has received grant support from, and has been a consultant for, Pfizer Inc. DTR has received grant support from Takeda; and has received consulting fees from AbbVie, AbGenomics, Allergan Inc, Boehringer Ingelheim, BMS, Celgene Corp/Syneos, Check-Cap, Dizal Pharmaceuticals, Eli Lilly, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GSK, Ichnos Sciences S.A., Janssen, Narrow River Management, Pfizer Inc, Prometheus Laboratories, Reistone, Shire, Takeda, and Techlab Inc. WR has received grant support from Abbott, AbbVie, AESCA, Centocor, Dr. Falk Pharma, Immundiagnostik, and MSD; has received lecture fees from Abbott, AbbVie, AESCA, Aptalis, Celltrion, Centocor, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Immundiagnostik, Mitsubishi Tanabe Pharma, MSD, Otsuka, PDL, Pharmacosmos, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; and has received consulting fees from Abbott, AbbVie, AESCA, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia Biologics, Bioclinica, Biogen Idec, Boehringer Ingelheim, BMS, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Galapagos, Genentech, Gilead Sciences, Grünenthal, ICON, Index Pharma, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestlé, Novartis, Ocera, Otsuka, PDL, Pfizer Inc, Pharmacosmos, Procter & Gamble, Prometheus Laboratories, Robarts Clinical Trials, Schering-Plough, Second Genome, SetPoint Medical, Takeda, Therakos, TiGenix, UCB, Vifor, Zyngenia, and 4SC. JY has received consulting fees from AstraZeneca and Eli Lilly; and has received a research grant from AstraZeneca. PCR has received personal fees from AbbVie, Atom Biosciences, Eli Lilly, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Roche, and UCB; and has received grant support from Janssen, Novartis, Pfizer Inc, and UCB. XZ, YC, BB, and AM are employees and shareholders of Pfizer Inc. JG was formerly employed by Pfizer Inc. JRC, XZ, BB, AM, and JG contributed to the conception and design of the study. All authors contributed to the acquisition, analysis and interpretation of the data, critically revised each draft of the manuscript for intellectual content, read and gave approval of the final version submitted for publication and accept accountability for the accuracy and integrity of the work. Address correspondence to Dr. X. Zhou, Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA. Email: xiaofeng.zhou@pfizer.com. Accepted for publication October 26, 2021.

This study was sponsored by Pfizer Inc. J.R. Curtis, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA; X. Zhou, PhD, Y. Chen, MD, B. Benda, MD, PhD, A. Madsen, PhD, J. Geier, PhD, Pfizer Inc, New York, New York, USA; D.T. Rubin, MD, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA; W. Reinisch, MD, Medical University of Vienna, Vienna, Austria; J. Yazdany, MD, Division of Rheumatology, Department of Medicine, University of California, San Francisco, California, USA; P.C. Robinson, MBChB, PhD, School of Clinical Medicine, Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia. JRC has received grant support from, and has been a consultant for, Pfizer Inc. DTR has received grant support from Takeda; and has received consulting fees from AbbVie, AbGenomics, Allergan Inc, Boehringer Ingelheim, BMS, Celgene Corp/Syneos, Check-Cap, Dizal Pharmaceuticals, Eli Lilly, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GSK, Ichnos Sciences S.A., Janssen, Narrow River Management, Pfizer Inc, Prometheus Laboratories, Reistone, Shire, Takeda, and Techlab Inc. WR has received grant support from Abbott, AbbVie, AESCA, Centocor, Dr. Falk Pharma, Immundiagnostik, and MSD; has received lecture fees from Abbott, AbbVie, AESCA, Aptalis, Celltrion, Centocor, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Immundiagnostik, Mitsubishi Tanabe Pharma, MSD, Otsuka, PDL, Pharmacosmos, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; and has received consulting fees from Abbott, AbbVie, AESCA, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia Biologics, Bioclinica, Biogen Idec, Boehringer Ingelheim, BMS, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Galapagos, Genentech, Gilead Sciences, Grünenthal, ICON, Index Pharma, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestlé, Novartis, Ocera, Otsuka, PDL, Pfizer Inc, Pharmacosmos, Procter & Gamble, Prometheus Laboratories, Robarts Clinical Trials, Schering-Plough, Second Genome, SetPoint Medical, Takeda, Therakos, TiGenix, UCB, Vifor, Zyngenia, and 4SC. JY has received consulting fees from AstraZeneca and Eli Lilly; and has received a research grant from AstraZeneca. PCR has received personal fees from AbbVie, Atom Biosciences, Eli Lilly, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Roche, and UCB; and has received grant support from Janssen, Novartis, Pfizer Inc, and UCB. XZ, YC, BB, and AM are employees and shareholders of Pfizer Inc. JG was formerly employed by Pfizer Inc. JRC, XZ, BB, AM, and JG contributed to the conception and design of the study. All authors contributed to the acquisition, analysis and interpretation of the data, critically revised each draft of the manuscript for intellectual content, read and gave approval of the final version submitted for publication and accept accountability for the accuracy and integrity of the work. Address correspondence to Dr. X. Zhou, Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA. Email: xiaofeng.zhou@pfizer.com. Accepted for publication October 26, 2021.

This study was sponsored by Pfizer Inc. J.R. Curtis, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA; X. Zhou, PhD, Y. Chen, MD, B. Benda, MD, PhD, A. Madsen, PhD, J. Geier, PhD, Pfizer Inc, New York, New York, USA; D.T. Rubin, MD, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA; W. Reinisch, MD, Medical University of Vienna, Vienna, Austria; J. Yazdany, MD, Division of Rheumatology, Department of Medicine, University of California, San Francisco, California, USA; P.C. Robinson, MBChB, PhD, School of Clinical Medicine, Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia. JRC has received grant support from, and has been a consultant for, Pfizer Inc. DTR has received grant support from Takeda; and has received consulting fees from AbbVie, AbGenomics, Allergan Inc, Boehringer Ingelheim, BMS, Celgene Corp/Syneos, Check-Cap, Dizal Pharmaceuticals, Eli Lilly, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GSK, Ichnos Sciences S.A., Janssen, Narrow River Management, Pfizer Inc, Prometheus Laboratories, Reistone, Shire, Takeda, and Techlab Inc. WR has received grant support from Abbott, AbbVie, AESCA, Centocor, Dr. Falk Pharma, Immundiagnostik, and MSD; has received lecture fees from Abbott, AbbVie, AESCA, Aptalis, Celltrion, Centocor, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Immundiagnostik, Mitsubishi Tanabe Pharma, MSD, Otsuka, PDL, Pharmacosmos, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; and has received consulting fees from Abbott, AbbVie, AESCA, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia Biologics, Bioclinica, Biogen Idec, Boehringer Ingelheim, BMS, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Galapagos, Genentech, Gilead Sciences, Grünenthal, ICON, Index Pharma, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestlé, Novartis, Ocera, Otsuka, PDL, Pfizer Inc, Pharmacosmos, Procter & Gamble, Prometheus Laboratories, Robarts Clinical Trials, Schering-Plough, Second Genome, SetPoint Medical, Takeda, Therakos, TiGenix, UCB, Vifor, Zyngenia, and 4SC. JY has received consulting fees from AstraZeneca and Eli Lilly; and has received a research grant from AstraZeneca. PCR has received personal fees from AbbVie, Atom Biosciences, Eli Lilly, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Roche, and UCB; and has received grant support from Janssen, Novartis, Pfizer Inc, and UCB. XZ, YC, BB, and AM are employees and shareholders of Pfizer Inc. JG was formerly employed by Pfizer Inc. JRC, XZ, BB, AM, and JG contributed to the conception and design of the study. All authors contributed to the acquisition, analysis and interpretation of the data, critically revised each draft of the manuscript for intellectual content, read and gave approval of the final version submitted for publication and accept accountability for the accuracy and integrity of the work. Address correspondence to Dr. X. Zhou, Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA. Email: xiaofeng.zhou@pfizer.com. Accepted for publication October 26, 2021.

This study was sponsored by Pfizer Inc. J.R. Curtis, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA; X. Zhou, PhD, Y. Chen, MD, B. Benda, MD, PhD, A. Madsen, PhD, J. Geier, PhD, Pfizer Inc, New York, New York, USA; D.T. Rubin, MD, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA; W. Reinisch, MD, Medical University of Vienna, Vienna, Austria; J. Yazdany, MD, Division of Rheumatology, Department of Medicine, University of California, San Francisco, California, USA; P.C. Robinson, MBChB, PhD, School of Clinical Medicine, Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia. JRC has received grant support from, and has been a consultant for, Pfizer Inc. DTR has received grant support from Takeda; and has received consulting fees from AbbVie, AbGenomics, Allergan Inc, Boehringer Ingelheim, BMS, Celgene Corp/Syneos, Check-Cap, Dizal Pharmaceuticals, Eli Lilly, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GSK, Ichnos Sciences S.A., Janssen, Narrow River Management, Pfizer Inc, Prometheus Laboratories, Reistone, Shire, Takeda, and Techlab Inc. WR has received grant support from Abbott, AbbVie, AESCA, Centocor, Dr. Falk Pharma, Immundiagnostik, and MSD; has received lecture fees from Abbott, AbbVie, AESCA, Aptalis, Celltrion, Centocor, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Immundiagnostik, Mitsubishi Tanabe Pharma, MSD, Otsuka, PDL, Pharmacosmos, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; and has received consulting fees from Abbott, AbbVie, AESCA, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia Biologics, Bioclinica, Biogen Idec, Boehringer Ingelheim, BMS, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Galapagos, Genentech, Gilead Sciences, Grünenthal, ICON, Index Pharma, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestlé, Novartis, Ocera, Otsuka, PDL, Pfizer Inc, Pharmacosmos, Procter & Gamble, Prometheus Laboratories, Robarts Clinical Trials, Schering-Plough, Second Genome, SetPoint Medical, Takeda, Therakos, TiGenix, UCB, Vifor, Zyngenia, and 4SC. JY has received consulting fees from AstraZeneca and Eli Lilly; and has received a research grant from AstraZeneca. PCR has received personal fees from AbbVie, Atom Biosciences, Eli Lilly, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Roche, and UCB; and has received grant support from Janssen, Novartis, Pfizer Inc, and UCB. XZ, YC, BB, and AM are employees and shareholders of Pfizer Inc. JG was formerly employed by Pfizer Inc. JRC, XZ, BB, AM, and JG contributed to the conception and design of the study. All authors contributed to the acquisition, analysis and interpretation of the data, critically revised each draft of the manuscript for intellectual content, read and gave approval of the final version submitted for publication and accept accountability for the accuracy and integrity of the work. Address correspondence to Dr. X. Zhou, Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA. Email: xiaofeng.zhou@pfizer.com. Accepted for publication October 26, 2021.

This study was sponsored by Pfizer Inc. J.R. Curtis, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA; X. Zhou, PhD, Y. Chen, MD, B. Benda, MD, PhD, A. Madsen, PhD, J. Geier, PhD, Pfizer Inc, New York, New York, USA; D.T. Rubin, MD, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA; W. Reinisch, MD, Medical University of Vienna, Vienna, Austria; J. Yazdany, MD, Division of Rheumatology, Department of Medicine, University of California, San Francisco, California, USA; P.C. Robinson, MBChB, PhD, School of Clinical Medicine, Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia. JRC has received grant support from, and has been a consultant for, Pfizer Inc. DTR has received grant support from Takeda; and has received consulting fees from AbbVie, AbGenomics, Allergan Inc, Boehringer Ingelheim, BMS, Celgene Corp/Syneos, Check-Cap, Dizal Pharmaceuticals, Eli Lilly, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GSK, Ichnos Sciences S.A., Janssen, Narrow River Management, Pfizer Inc, Prometheus Laboratories, Reistone, Shire, Takeda, and Techlab Inc. WR has received grant support from Abbott, AbbVie, AESCA, Centocor, Dr. Falk Pharma, Immundiagnostik, and MSD; has received lecture fees from Abbott, AbbVie, AESCA, Aptalis, Celltrion, Centocor, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Immundiagnostik, Mitsubishi Tanabe Pharma, MSD, Otsuka, PDL, Pharmacosmos, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; and has received consulting fees from Abbott, AbbVie, AESCA, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia Biologics, Bioclinica, Biogen Idec, Boehringer Ingelheim, BMS, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Galapagos, Genentech, Gilead Sciences, Grünenthal, ICON, Index Pharma, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestlé, Novartis, Ocera, Otsuka, PDL, Pfizer Inc, Pharmacosmos, Procter & Gamble, Prometheus Laboratories, Robarts Clinical Trials, Schering-Plough, Second Genome, SetPoint Medical, Takeda, Therakos, TiGenix, UCB, Vifor, Zyngenia, and 4SC. JY has received consulting fees from AstraZeneca and Eli Lilly; and has received a research grant from AstraZeneca. PCR has received personal fees from AbbVie, Atom Biosciences, Eli Lilly, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Roche, and UCB; and has received grant support from Janssen, Novartis, Pfizer Inc, and UCB. XZ, YC, BB, and AM are employees and shareholders of Pfizer Inc. JG was formerly employed by Pfizer Inc. JRC, XZ, BB, AM, and JG contributed to the conception and design of the study. All authors contributed to the acquisition, analysis and interpretation of the data, critically revised each draft of the manuscript for intellectual content, read and gave approval of the final version submitted for publication and accept accountability for the accuracy and integrity of the work. Address correspondence to Dr. X. Zhou, Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA. Email: xiaofeng.zhou@pfizer.com. Accepted for publication October 26, 2021.

This study was sponsored by Pfizer Inc. J.R. Curtis, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA; X. Zhou, PhD, Y. Chen, MD, B. Benda, MD, PhD, A. Madsen, PhD, J. Geier, PhD, Pfizer Inc, New York, New York, USA; D.T. Rubin, MD, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA; W. Reinisch, MD, Medical University of Vienna, Vienna, Austria; J. Yazdany, MD, Division of Rheumatology, Department of Medicine, University of California, San Francisco, California, USA; P.C. Robinson, MBChB, PhD, School of Clinical Medicine, Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia. JRC has received grant support from, and has been a consultant for, Pfizer Inc. DTR has received grant support from Takeda; and has received consulting fees from AbbVie, AbGenomics, Allergan Inc, Boehringer Ingelheim, BMS, Celgene Corp/Syneos, Check-Cap, Dizal Pharmaceuticals, Eli Lilly, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GSK, Ichnos Sciences S.A., Janssen, Narrow River Management, Pfizer Inc, Prometheus Laboratories, Reistone, Shire, Takeda, and Techlab Inc. WR has received grant support from Abbott, AbbVie, AESCA, Centocor, Dr. Falk Pharma, Immundiagnostik, and MSD; has received lecture fees from Abbott, AbbVie, AESCA, Aptalis, Celltrion, Centocor, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Immundiagnostik, Mitsubishi Tanabe Pharma, MSD, Otsuka, PDL, Pharmacosmos, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; and has received consulting fees from Abbott, AbbVie, AESCA, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia Biologics, Bioclinica, Biogen Idec, Boehringer Ingelheim, BMS, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Galapagos, Genentech, Gilead Sciences, Grünenthal, ICON, Index Pharma, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestlé, Novartis, Ocera, Otsuka, PDL, Pfizer Inc, Pharmacosmos, Procter & Gamble, Prometheus Laboratories, Robarts Clinical Trials, Schering-Plough, Second Genome, SetPoint Medical, Takeda, Therakos, TiGenix, UCB, Vifor, Zyngenia, and 4SC. JY has received consulting fees from AstraZeneca and Eli Lilly; and has received a research grant from AstraZeneca. PCR has received personal fees from AbbVie, Atom Biosciences, Eli Lilly, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Roche, and UCB; and has received grant support from Janssen, Novartis, Pfizer Inc, and UCB. XZ, YC, BB, and AM are employees and shareholders of Pfizer Inc. JG was formerly employed by Pfizer Inc. JRC, XZ, BB, AM, and JG contributed to the conception and design of the study. All authors contributed to the acquisition, analysis and interpretation of the data, critically revised each draft of the manuscript for intellectual content, read and gave approval of the final version submitted for publication and accept accountability for the accuracy and integrity of the work. Address correspondence to Dr. X. Zhou, Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA. Email: xiaofeng.zhou@pfizer.com. Accepted for publication October 26, 2021.

This study was sponsored by Pfizer Inc. J.R. Curtis, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA; X. Zhou, PhD, Y. Chen, MD, B. Benda, MD, PhD, A. Madsen, PhD, J. Geier, PhD, Pfizer Inc, New York, New York, USA; D.T. Rubin, MD, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA; W. Reinisch, MD, Medical University of Vienna, Vienna, Austria; J. Yazdany, MD, Division of Rheumatology, Department of Medicine, University of California, San Francisco, California, USA; P.C. Robinson, MBChB, PhD, School of Clinical Medicine, Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia. JRC has received grant support from, and has been a consultant for, Pfizer Inc. DTR has received grant support from Takeda; and has received consulting fees from AbbVie, AbGenomics, Allergan Inc, Boehringer Ingelheim, BMS, Celgene Corp/Syneos, Check-Cap, Dizal Pharmaceuticals, Eli Lilly, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, GSK, Ichnos Sciences S.A., Janssen, Narrow River Management, Pfizer Inc, Prometheus Laboratories, Reistone, Shire, Takeda, and Techlab Inc. WR has received grant support from Abbott, AbbVie, AESCA, Centocor, Dr. Falk Pharma, Immundiagnostik, and MSD; has received lecture fees from Abbott, AbbVie, AESCA, Aptalis, Celltrion, Centocor, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Immundiagnostik, Mitsubishi Tanabe Pharma, MSD, Otsuka, PDL, Pharmacosmos, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; and has received consulting fees from Abbott, AbbVie, AESCA, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia Biologics, Bioclinica, Biogen Idec, Boehringer Ingelheim, BMS, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone, Dr. Falk Pharma, Elan, Ferring Pharmaceuticals, Galapagos, Genentech, Gilead Sciences, Grünenthal, ICON, Index Pharma, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestlé, Novartis, Ocera, Otsuka, PDL, Pfizer Inc, Pharmacosmos, Procter & Gamble, Prometheus Laboratories, Robarts Clinical Trials, Schering-Plough, Second Genome, SetPoint Medical, Takeda, Therakos, TiGenix, UCB, Vifor, Zyngenia, and 4SC. JY has received consulting fees from AstraZeneca and Eli Lilly; and has received a research grant from AstraZeneca. PCR has received personal fees from AbbVie, Atom Biosciences, Eli Lilly, Gilead Sciences, Janssen, Novartis, Pfizer Inc, Roche, and UCB; and has received grant support from Janssen, Novartis, Pfizer Inc, and UCB. XZ, YC, BB, and AM are employees and shareholders of Pfizer Inc. JG was formerly employed by Pfizer Inc. JRC, XZ, BB, AM, and JG contributed to the conception and design of the study. All authors contributed to the acquisition, analysis and interpretation of the data, critically revised each draft of the manuscript for intellectual content, read and gave approval of the final version submitted for publication and accept accountability for the accuracy and integrity of the work. Address correspondence to Dr. X. Zhou, Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA. Email: xiaofeng.zhou@pfizer.com. Accepted for publication October 26, 2021.