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1. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis

Author

Fraenkel, Liana, Bathon, Joan M, England, Bryant R, St.Clair, E William, Arayssi, Thurayya, Carandang, Kristine, Deane, Kevin D, Genovese, Mark, Huston, Kent Kwas, Kerr, Gail, Kremer, Joel, Nakamura, Mary C, Russell, Linda A, Singh, Jasvinder A, Smith, Benjamin J, Sparks, Jeffrey A, Venkatachalam, Shilpa, Weinblatt, Michael E, Al‐Gibbawi, Mounir, Baker, Joshua F, Barbour, Kamil E, Barton, Jennifer L, Cappelli, Laura, Chamseddine, Fatimah, George, Michael, Johnson, Sindhu R, Kahale, Lara, Karam, Basil S, Khamis, Assem M, Navarro-Millán, Iris, Mirza, Reza, Schwab, Pascale, Singh, Namrata, Turgunbaev, Marat, Turner, Amy S, Yaacoub, Sally, and Akl, Elie A

Subjects
Arthritis, Clinical Research, Management of diseases and conditions, 7.3 Management and decision making, Inflammatory and immune system, Good Health and Well Being, Antirheumatic Agents, Arthritis, Rheumatoid, Clinical Decision-Making, Consensus, Decision Support Techniques, Humans, Remission Induction, Rheumatology, Treatment Outcome, Clinical Sciences, Public Health and Health Services, Psychology
Abstract

ObjectiveTo develop updated guidelines for the pharmacologic management of rheumatoid arthritis.MethodsWe developed clinically relevant population, intervention, comparator, and outcomes (PICO) questions. After conducting a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the certainty of evidence. A voting panel comprising clinicians and patients achieved consensus on the direction (for or against) and strength (strong or conditional) of recommendations.ResultsThe guideline addresses treatment with disease-modifying antirheumatic drugs (DMARDs), including conventional synthetic DMARDs, biologic DMARDs, and targeted synthetic DMARDs, use of glucocorticoids, and use of DMARDs in certain high-risk populations (i.e., those with liver disease, heart failure, lymphoproliferative disorders, previous serious infections, and nontuberculous mycobacterial lung disease). The guideline includes 44 recommendations (7 strong and 37 conditional).ConclusionThis clinical practice guideline is intended to serve as a tool to support clinician and patient decision-making. Recommendations are not prescriptive, and individual treatment decisions should be made through a shared decision-making process based on patients' values, goals, preferences, and comorbidities.

Published
2021

2. Development of the American College of Rheumatology's Rheumatoid Arthritis Electronic Clinical Quality Measures

Author

Yazdany, Jinoos, Robbins, Mark, Schmajuk, Gabriela, Desai, Sonali, Lacaille, Diane, Neogi, Tuhina, Singh, Jasvinder A, Genovese, Mark, Myslinski, Rachel, Fisk, Natalie, Francisco, Melissa, and Newman, Eric

Subjects
Rheumatoid Arthritis, Health Services, Arthritis, Networking and Information Technology R&D (NITRD), Clinical Research, Autoimmune Disease, Inflammatory and immune system, Good Health and Well Being, Algorithms, Antirheumatic Agents, Arthritis, Rheumatoid, Electronic Health Records, Humans, Outcome Assessment, Health Care, Quality Assurance, Health Care, Registries, Reproducibility of Results, Rheumatology, Societies, Medical, United States, Clinical Sciences, Public Health and Health Services, Psychology
Abstract

ObjectiveElectronic clinical quality measures (eCQMs) rely on computer algorithms to extract data from electronic health records (EHRs). On behalf of the American College of Rheumatology (ACR), we sought to develop and test eCQMs for rheumatoid arthritis (RA).MethodsDrawing from published ACR guidelines, a working group developed candidate RA process measures and subsequently assessed face validity through an interdisciplinary panel of health care stakeholders. A public comment period followed. Measures that passed these levels of review were electronically specified using the quality data model, which provides standard nomenclature for data elements (category, datatype, and value sets) obtained through an EHR. For each eCQM, 3 clinical sites using different EHR systems tested the scientific feasibility and validity of measures. Measures appropriate for accountability were presented for national endorsement.ResultsExpert panel validity ratings were high for all measures (median 8-9 of 9). Health system performance on the eCQMs was 53.6% for RA disease activity assessment, 69.1% for functional status assessment, 93.1% for disease-modifying antirheumatic drug (DMARD) use, and 72.8% for tuberculosis screening. Kappa statistics, which evaluated whether the eCQM validly captured data obtained from manual EHR chart review, demonstrated moderate to substantial agreement (0.54 for functional status assessment, 0.73 for tuberculosis screening, 0.84 for disease activity, and 0.85 for DMARD use).ConclusionFour eCQMs for RA have achieved national endorsement and are recommended for use in federal quality reporting programs. Implementation and further refinement of these measures is ongoing in the ACR's registry, the Rheumatology Informatics System for Effectiveness (RISE).

Published
2016

14. Long-Term Safety, Efficacy, and Patient-Centered Outcomes of Filgotinib in the Treatment of Rheumatoid Arthritis: Current Perspectives

Author

Tanaka,Yoshiya, Genovese,Mark C, Matsushima,Hironori, Tanaka,Yoshiya, Genovese,Mark C, and Matsushima,Hironori

Abstract

Yoshiya Tanaka,1 Mark C Genovese,2,3 Hironori Matsushima4 1The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan; 2Division of Immunology and Rheumatology, Stanford University, Stanford, CA, USA; 3Gilead Sciences, Inc, Foster City, CA, USA; 4Gilead Sciences, Inc, Tokyo, JapanCorrespondence: Yoshiya Tanaka, The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, 1-1 Iseigaoka, Yahata-nishi, Kitakyushu, 807-8555, Japan, Tel +81-93-603-1611, Fax +81-93-691-7580, Email tanaka@med.uoeh-u.ac.jpAbstract: Filgotinib is an orally administered, preferential Janus kinase (JAK) inhibitor indicated for the treatment of moderate-to-severe rheumatoid arthritis (RA). The short-term safety, efficacy, and patient-reported outcomes (PROs) with filgotinib from Phase 2b/3 clinical trials (DARWIN 1 and 2; FINCH 1, 2, and 3) are described in patients who inadequately responded to methotrexate (MTX) and biologic disease-modifying antirheumatic drugs or who were naïve to MTX. This article reviews the safety and efficacy from the long-term extension (LTE) trials, DARWIN 3 (N=739) and FINCH 4 (N=2731), and PROs across the filgotinib development program in RA. Overall, in the DARWIN clinical trials (conducted from 2013– 2023), patients received their LTE treatment for ≤ 8 years, while in the FINCH trials (ongoing from 2016– 2025), patients received filgotinib treatment for ≤ 6 years in the LTE. The longer-term safety profile and consistent, sustained efficacy (American College of Rheumatology 20/50/70, Clinical Disease Activity Index, and Disease Activity Scale in 28 joints with C-reactive protein response rates) of filgotinib were largely similar to those observed in the shorter-term parent trials ≤ 52 weeks. PRO results from the parent trials showed improvements in patients’ quality of life with filgotinib treatment, which compar

Published
2023

15. A Randomized, Double‐Blind, Sham‐Controlled, Clinical Trial of Auricular Vagus Nerve Stimulation for the Treatment of Active Rheumatoid Arthritis.

Author

Baker, Matthew C., Kavanagh, Sarah, Cohen, Stanley, Matsumoto, Alan K., Dikranian, Ara, Tesser, John, Kivitz, Alan, Alataris, Konstantinos, and Genovese, Mark C.

Subjects
RHEUMATOID arthritis treatment, BIOTHERAPY, RHEUMATOID arthritis diagnosis, C-reactive protein, VAGUS nerve, ANTIRHEUMATIC agents, TREATMENT effectiveness, RANDOMIZED controlled trials, BLIND experiment, QUESTIONNAIRES, DESCRIPTIVE statistics, STATISTICAL sampling, DATA analysis software, NEURAL stimulation, TRANSCUTANEOUS electrical nerve stimulation
Abstract

Objective: Preliminary evidence suggests that vagus nerve stimulation (VNS) may have some benefit in patients with rheumatoid arthritis (RA); however, prior studies have been small and/or uncontrolled; this study aimed to address that gap. Methods: This randomized, double‐blind, sham‐controlled trial enrolled patients aged 18 to 75 years with active RA who had failed conventional synthetic disease‐modifying antirheumatic drugs (DMARDs) and were naïve to biologic and/or targeted synthetic DMARDs. All patients received an auricular vagus nerve stimulator and were randomized 1:1 to active stimulation or sham. The primary endpoint was the proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Secondary endpoints included mean changes in disease activity score of 28 joints with C‐reactive protein (DAS28‐CRP) and Health Assessment Questionnaire‐Disability Index (HAQ‐DI). Results: A total of 113 patients (mean age 54 years; 82% female) enrolled, and 101 patients (89.4%) completed week 12. ACR20 response at week 12 was 25.0% for active stimulation versus 26.9% for sham (difference vs. sham, −1.9; 95% CI, −18.8, 14.9, P = 0.823). The least square mean ± SE change in DAS28‐CRP was −0.95 ± 0.16 for active stimulation and −0.66 ± 0.16 for sham (P = 0.201); in HAQ‐DI it was −0.19 ± 0.06 for active stimulation and −0.02 ± 0.06 for sham (P = 0.044). Adverse events occurred in 17 patients (15%); all were mild or moderate. Conclusion: Auricular VNS did not meaningfully improve RA disease activity. If VNS with other modalities is pursued in the future for the treatment of RA, larger, controlled studies will be needed to understand its utility. [ABSTRACT FROM AUTHOR]

Published
2023
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19. Characterisation of the safety profile of evobrutinib in over 1000 patients from phase II clinical trials in multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus: an integrated safety analysis

Author

Montalban, Xavier, Wallace, Daniel, Genovese, Mark C., Tomic, Davorka Lucia, Parsons-Rich, Dana, Le Bolay, Claire, Kao, Amy H., Guehring, Hans, Universitat Autònoma de Barcelona, Institut Català de la Salut, [Montalban X] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Wallace D] Cedars-Sinai Medical Center, David Geffen School of Medicine, University of California, Los Angeles, California, USA. [Genovese MC] Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA. [Tomic D] Global Clinical Development, Ares Trading SA, Eysins, Switzerland, an affiliate of Merck KGaA. [Parsons-Rich D] Global Clinical Development, EMD Serono Research & Development Institute, Inc, Billerica, Massachusetts, USA, an affiliate of Merck KGaA (affiliation at the time the research was conducted). ECD-Early Clinical Development, Pfizer, Cambridge, Massachusetts, USA. [Le Bolay C] Biostatistics, Merck Healthcare KGaA, Darmstadt, Germany. [Kao AH] Translational Innovation Platform in Immunology & Neuroscience, EMD Serono Research & Development Institute, Inc, Billerica, Massachusetts, USA, an affiliate of Merck KGaA. [Guehring H] Global Patient Safety, Merck Healthcare KGaA, Darmstadt, Germany, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Other subheadings::Other subheadings::/antagonists & inhibitors [Other subheadings], Immune System Diseases::Autoimmune Diseases::Lupus Erythematosus, Systemic [DISEASES], Artritis reumatoide - Tractament, Immunology, SLE, Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis [DISEASES], enfermedades musculoesqueléticas::artropatías::artritis::artritis reumatoide [ENFERMEDADES], Multiple sclerosis, Psychiatry and Mental health, Rheumatology, Lupus eritematós - Tractament, enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES], enzimas y coenzimas::enzimas::transferasas::fosfotransferasas::fosfotransferasas (grupo alcohol aceptor)::proteína cinasas::proteína-tirosina cinasas [COMPUESTOS QUÍMICOS Y DROGAS], Surgery, Neurology (clinical), Otros calificadores::Otros calificadores::/antagonistas & inhibidores [Otros calificadores], Enzymes and Coenzymes::Enzymes::Transferases::Phosphotransferases::Phosphotransferases (Alcohol Group Acceptor)::Protein Kinases::Protein-Tyrosine Kinases [CHEMICALS AND DRUGS], Esclerosi múltiple - Tractament, Musculoskeletal Diseases::Joint Diseases::Arthritis::Arthritis, Rheumatoid [DISEASES], enfermedades del sistema inmune::enfermedades autoinmunes::lupus eritematoso sistémico [ENFERMEDADES], Proteïnes quinases - Inhibidors - Ús terapèutic
Abstract

ObjectiveAnalyse the integrated safety profile of evobrutinib, a Bruton’s tyrosine kinase inhibitor (BTKi), using pooled data from multiple sclerosis (MS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) trials.MethodsPhase II, randomised, double-blind, placebo-controlled trial data were analysed (N=1083; MS: n=213, 48 weeks (W); RA: n=390, 12W; SLE: n=480, 52W). The analysis included all patients who received ≥1 dose of evobrutinib (25 mg or 75 mg once daily, or 50 mg or 75 mgtwice daily) or placebo. Descriptive statistics and exposure-adjusted incidence rates (EAIR) were used to report treatment-emergent adverse events (TEAEs).ResultsData from 1083 patients were pooled: evobrutinib, n=861; placebo, n=271 (sum >1083 due to MS trial design: n=49 received both placebo (W0–24) and evobrutinib 25 mg (W25–48)); median follow-up time (pt-years): evobrutinib, 0.501; placebo, 0.463. Across indications, the proportion of patients with TEAEs and the EAIR were similar for evobrutinib and placebo (66.2% (247.6 events/100 pt-years) vs 62.4% (261.4 events/100 pt-years)). By indication, the EAIR (events/100 pt-years) of TEAEs for evobrutinib versus placebo were: MS: 119.7 vs 148.3; RA: 331.8 vs 306.8; SLE: 343.0 vs 302.1. Two fatal events occurred (in SLE). The serious infections EAIR was 2.7 and 2.1 events/100 pt-years for evobrutinib and placebo. For previously reported BTKi-class effects, the EAIR of transient elevated alanine aminotransferase/aspartate aminotransferase TEAEs (events/100 pt-years) with evobrutinib versus placebo was 4.8 vs 2.8/3.5 vs 0.7, respectively. IgG levels were similar in evobrutinib/placebo-treated patients.ConclusionsThis is the first BTKi-integrated safety analysis that includes patients with MS. Overall, evobrutinib treatment (all doses) was generally well tolerated across indications.Trial registration numbersNCT02975349,NCT03233230,NCT02975336.

Published
2022

24. Sarilumab Plus Methotrexate in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study

Author

Genovese, Mark C., Fleischmann, Roy, Kivitz, Alan J., Rell-Bakalarska, Maria, Martincova, Renata, Fiore, Stefano, Rohane, Patricia, van Hoogstraten, Hubert, Garg, Anju, Fan, Chunpeng, van Adelsberg, Janet, Weinstein, Steven P., Graham, Neil M. H., Stahl, Neil, Yancopoulos, George D., Huizinga, Tom W. J., and van der Heijde, Désirée

Published
2015
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25. Fenebrutinib Versus Placebo or Adalimumab in Rheumatoid Arthritis: A Randomized, Double‐Blind, Phase II Trial

Author

Cohen, Stanley, primary, Tuckwell, Katie, additional, Katsumoto, Tamiko R., additional, Zhao, Rui, additional, Galanter, Joshua, additional, Lee, Chin, additional, Rae, Julie, additional, Toth, Balazs, additional, Ramamoorthi, Nandhini, additional, Hackney, Jason A., additional, Berman, Alberto, additional, Damjanov, Nemanja, additional, Fedkov, Dmytro, additional, Jeka, Slawomir, additional, Chinn, Leslie W., additional, Townsend, Michael J., additional, Morimoto, Alyssa M., additional, Genovese, Mark C., additional, Porto, Alejandro, additional, Granel, Amelia, additional, Asnal, Cecilia, additional, Mysler, Eduardo Fabian, additional, Testa, Gladys Alicia, additional, Zamora, Jose Luis Velasco, additional, Moreno, Jose Luis Cristian, additional, Gulin, Juan Pablo, additional, Hofman, Julio, additional, Ulla, Maria Rosa, additional, Sabelli, Mirtha, additional, Mannucci, Pablo Alejandro, additional, Maid, Pablo Jorge, additional, Melazzi, Ana Cláudia Cauceglia, additional, Scotton, Antônio Scafuto, additional, Ximenes, Antônio Carlos, additional, Funes, Elisete, additional, Gimenez, Emerson Alves, additional, Marcolino, Flora Maria D’Andrea, additional, Neto, João Francisco Marques, additional, Keiserman, Mauro Waldemar, additional, Radominski, Sebastião Cézar, additional, Lima, Sônia Maria Alvarenga Anti Loduca, additional, Pavan, Thaís Rohde, additional, Azevedo, Valderílio Feijó, additional, Koleva, Aneliya, additional, Toncheva, Antoaneta, additional, Bichovska, Daniela, additional, Ivanova, Delina, additional, Penev, Dimitar, additional, Dimitrov, Emil, additional, Mihaylova, Mariyana, additional, Kapandjieva, Nadezhda, additional, Marinova, Natalia, additional, Aleksieva, Tanya, additional, Tsvetanova, Tanya, additional, Petranova, Tsvetanka, additional, Popova, Valentina, additional, Spasov, Yuliy, additional, Toro, Carlos Enrique, additional, Arteaga Unigarro, Carlos Ernesto, additional, Jauregui, Edwin, additional, Hernandez, Javier Dario Marquez, additional, Raad, Juan Jose Jaller, additional, Sanchez, Patricia Julieta Velez, additional, Lee, Chang Keun, additional, Suh, Chang‐Hee, additional, Lee, Eun Young, additional, Lee, Sang‐Heon, additional, Kang, Seong Wook, additional, Lee, Shin‐Seok, additional, Lee, Yun Jong, additional, Montiel, Beatriz Elena Zazueta, additional, Pinzon de la O, Blanca Irma, additional, Friedmann, Daniel Xibille, additional, Lopez, Francisco Rosas, additional, Torres, Isaura Rodriguez, additional, Quezada, Luis Jara, additional, Ceceña, Marco Maradiaga, additional, Hernandez, Miguel Cortes, additional, Salinas, Miguel Saavedra, additional, Rapa, Agnieszka, additional, Pawtel, Agnieszka, additional, Zielinska, Agnieszka, additional, Dudek, Anna, additional, Rychlewska‐Hanczewska, Anna, additional, Strzelecka, Anna, additional, Racewicz, Artur, additional, Stasiuk, Barbara, additional, Gruszecka, Katarzyna, additional, Dworak, Krystyna, additional, Lowenhoff, Tomasz, additional, Maslyanskiy, Alexey, additional, Rebrov, Andrey, additional, Krechikova, Diana, additional, Zhugrova, Elena, additional, Shmidt, Evgeniya, additional, Matsievskaya, Galina, additional, Vinogradova, Irina, additional, Ler, Irina, additional, Eliseeva, Larisa, additional, Savina, Ludmila, additional, Stanislav, Marina, additional, Sandin, Mikhail, additional, Zyablova, Natalia, additional, Korshunov, Nikolay, additional, Mosesova, Nino, additional, Polovnikova, Oksana, additional, Nesmeyanova, Olga, additional, Samigullina, Ruzana, additional, Moiseev, Sergey, additional, Noskov, Sergey, additional, Raskina, Tatiana, additional, Popova, Tatiana, additional, Marchenko, Valeriy, additional, Jovanovski, Aleksandar, additional, Stamenkovic, Bojana, additional, Ristic, Gorica, additional, Lazarevic, Milijanka, additional, Veselinovic, Mirjana, additional, Vujasinovic‐Stupar, Nada, additional, Ostojic, Predrag, additional, Yagensky, Andriy, additional, Gnylorybov, Andriy, additional, Rekalov, Dmytro, additional, Reshotko, Dmytroo, additional, Dzyak, Georgiy, additional, Gasanov, Iurii, additional, Khimion, Ludmila, additional, Stanislavchuk, Mykola, additional, Prykhodko, Natalya, additional, Nadashkevych, Oleg, additional, Bortkevych, Oleg, additional, Abrahamovych, Orest, additional, Yatsyshyn, Roman, additional, Turyanytsya, Samvel, additional, Smiyan, Svitlana, additional, Vizir, Vadym, additional, Kachur, Victoria, additional, Tseluyko, Vira, additional, Povoroznyuk, Vladyslav, additional, Koshlia, Volodymyr, additional, Zhdan, Vyacheslav, additional, Lymar, Yurii, additional, Mostovoy, Yuriy, additional, Hawkes, Angela, additional, Mabaquiao, Arthur, additional, Chu, Cong‐Qiu, additional, Scoville, Craig, additional, Wyatt, David, additional, Weinstein, Debra, additional, McIlwain, Harris, additional, Vo, Jacqueline, additional, Poiley, Jeffrey, additional, Forstot, Joseph, additional, Dao, Kathryn, additional, Turner, Mark, additional, Genovese, Mark, additional, Borofsky, Michael, additional, Caldron, Paul, additional, Waller, Philip, additional, Levin, Robert, additional, Metyas, Samy, additional, Stein, Scott, additional, Shroff, Sharukh, additional, Pang, Shirley, additional, Cohen, Stanley, additional, Syed, Tauseef, additional, and Chindalore, Vishala, additional

Published
2020
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26. Effects of Fostamatinib, an Oral Spleen Tyrosine Kinase Inhibitor, in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate: Results From a Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Author

Weinblatt, Michael E., Genovese, Mark C., Ho, Meilien, Hollis, Sally, Rosiak-Jedrychowicz, Krystyna, Kavanaugh, Arthur, Millson, David S., Leon, Gustavo, Wang, Millie, and van der Heijde, Désirée

Published
2014
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29. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis

Author

Fraenkel, Liana, primary, Bathon, Joan M., additional, England, Bryant R., additional, St.Clair, E. William, additional, Arayssi, Thurayya, additional, Carandang, Kristine, additional, Deane, Kevin D., additional, Genovese, Mark, additional, Huston, Kent Kwas, additional, Kerr, Gail, additional, Kremer, Joel, additional, Nakamura, Mary C., additional, Russell, Linda A., additional, Singh, Jasvinder A., additional, Smith, Benjamin J., additional, Sparks, Jeffrey A., additional, Venkatachalam, Shilpa, additional, Weinblatt, Michael E., additional, Al‐Gibbawi, Mounir, additional, Baker, Joshua F., additional, Barbour, Kamil E., additional, Barton, Jennifer L., additional, Cappelli, Laura, additional, Chamseddine, Fatimah, additional, George, Michael, additional, Johnson, Sindhu R., additional, Kahale, Lara, additional, Karam, Basil S., additional, Khamis, Assem M., additional, Navarro-Millán, Iris, additional, Mirza, Reza, additional, Schwab, Pascale, additional, Singh, Namrata, additional, Turgunbaev, Marat, additional, Turner, Amy S., additional, Yaacoub, Sally, additional, and Akl, Elie A., additional

Published
2021
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30. Long-term safety and efficacy of olokizumab in patients with rheumatoid arthritis and inadequate response to tumor necrosis factor inhibitor therapy in phase II studies.

Author

UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Genovese, Mark C, Durez, Patrick, Fleischmann, Roy, Tanaka, Yoshiya, Furst, Daniel, Yamanaka, Hisashi, Korneva, Elena, Vasyutin, Igor, Takeuchi, Tsutomu, UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Genovese, Mark C, Durez, Patrick, Fleischmann, Roy, Tanaka, Yoshiya, Furst, Daniel, Yamanaka, Hisashi, Korneva, Elena, Vasyutin, Igor, and Takeuchi, Tsutomu

Abstract

This study aimed to evaluate the long-term safety and efficacy of olokizumab (OKZ), an anti-interleukin (IL)-6 monoclonal antibody, in patients with rheumatoid arthritis (RA) and inadequate response to tumor necrosis factor-alpha inhibitors. Eligible patients completed study RA0056, which tested several doses of OKZ, placebo (PBO), and tocilizumab (TCZ) plus methotrexate (MTX) in Western countries, and RA0083 included several doses of OKZ and PBO plus MTX in Asian countries. Both studies were followed by open-label extension (OLE) studies with OKZ 120 mg every 2 weeks, RA0057 and RA0089, respectively. Safety assessments were reported up to 124 weeks in RA0057 and 92 weeks in RA0089. Efficacy assessments were reported up to week 60 in RA0057 and week 52 in RA0089. No formal statistical hypothesis testing was performed, and missing data were not imputed. A total of 190 patients in RA0057 and 103 patients in RA0089 received OKZ with median treatment duration of 14.1 and 10.1 months, respectively. Serious adverse events (SAEs) were reported in 44 patients (23.2%, 32.7 events per 100 patient-years [PY]) in RA0057 and in 13 patients (12.6%, 23.6 events per 100 PY) in RA0089. Among treatment-emergent adverse events (TEAEs), including SAEs, infections were the most common events. TEAEs leading to withdrawal were reported in 33 (17.4%) patients in RA0057 and in 7 (6.8%) patients in RA0089. Disease activity score 28-joint count on the basis of C-reactive protein level, clinical disease activity index, and simplified disease activity index, as well as the American College of Rheumatology 20%, 50%, and 70% response rates were maintained during the OLE studies, including in those who switched from PBO or TCZ. Improvements in patient-reported outcomes were maintained in OLEs as well. In the 2 long-term studies, OKZ treatment demonstrated a safety profile expected for IL-6 blocking agents without new safety signals and led to sustained improvements in RA symptoms, physical functio

Published
2021

31. Selective tyrosine kinase inhibition by imatinib mesylate for the treatment of autoimmune arthritis

Author

Paniagua, Ricardo T., Sharpe, Orr, Ho, Peggy P., Chan, Steven M., Chang, Anna, Higgins, John P., Tomooka, Beren H., Thomas, Fiona M., Song, Jason J., Goodman, Stuart B., Lee, David M., Genovese, Mark C., Utz, Paul J., Steinman, Lawrence, and Robinson, William H.

Subjects
Rheumatoid arthritis -- Care and treatment, Tyrosine -- Research
Abstract

Tyrosine kinases play a central role in the activation of signal transduction pathways and cellular responses that mediate the pathogenesis of rheumatoid arthritis. Imatinib mesylate (imatinib) is a tyrosine kinase [...]

Published
2006

33. P171 Efficacy and safety of upadacitinib in patients with active PsA and inadequate response to biologic DMARDs (SELECT-PsA-2): a double-blind, randomised controlled Phase III trial

Author

Genovese, Mark C, primary, Lertratanakul, Apinya, additional, Anderson, Jaclyn, additional, Papp, Kim, additional, Tillett, William, additional, van den Bosch, Filip, additional, Tsuji, Shigeyoshi, additional, Dokoupilova, Eva, additional, Keiserman, Mauro, additional, Wang, Xin, additional, Zhong, Sheng, additional, Zueger, Patrick, additional, Pangan, Aileen, additional, and Mease, Philip, additional

Published
2021
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34. Corrigendum to: Safety of ixekizumab in adult patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis: data from 21 clinical trials

Author

Genovese, Mark C, primary, Mysler, Eduardo, additional, Tomita, Tetsuya, additional, Papp, Kim A, additional, Salvarani, Carlo, additional, Schwartzman, Sergio, additional, Gallo, Gaia, additional, Patel, Himanshu, additional, Lisse, Jeffrey R, additional, Kronbergs, Andris, additional, Leage, Soyi Liu, additional, Adams, David H, additional, Xu, Wen, additional, Marzo-Ortega, Helena, additional, and Lebwohl, Mark G, additional

Published
2021
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36. The Incidence, Prevalence, and Associated Costs of Anemia, Malignancy, Venous Thromboembolism, Major Adverse Cardiovascular Events, and Infections in Rheumatoid Arthritis Patients by Treatment History in the United States.

Author

Dore, Robin K., Antonova, Jenya N., Burudpakdee, Chakkarin, Chang, Lawrence, Gorritz, Magdaliz, and Genovese, Mark C.

Subjects
MAJOR adverse cardiovascular events, THROMBOEMBOLISM, UNITED States history, RHEUMATOID arthritis, MEDICAL care costs, HERPES zoster
Abstract

Objective: Comorbidities in rheumatoid arthritis (RA) can influence treatment selection, impact treatment persistency, and increase health care costs. This study assessed the magnitude of comorbidity burden via epidemiology (incidence and prevalence) and associated costs of select comorbidities in RA patients: anemia, malignancy, venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and infections, stratified by history of disease‐modifying antirheumatic drug (DMARD) exposure. Methods: From the IQVIA PharMetrics® Plus database, we selected adult patients with RA (2 or more RA diagnostic codes at least 30 days apart) at initiation of a new DMARD (DMARD‐naïve), after the first conventional synthetic DMARD (csDMARD) or after the first biologic DMARD (bDMARD). We assessed pre‐index prevalence (percentage) and on‐treatment incidence (per 100 patient‐years [P100PY]) of the aforementioned comorbidities. For patients with versus without incident conditions, we compared total all‐cause health care costs as unadjusted and adjusted for baseline characteristics and health care costs. Results: Prior to initiating a new treatment, among DMARD‐naïve patients (N = 28,201), csDMARD switchers (N = 7,816), or bDMARD switchers (N = 4,656), the overall prevalence ranged from 14.1% to 16.2% (anemia), from 1.3% to 5.2% (malignancy, evaluated in csDMARD and bDMARD switchers), from 1.5% to 2.1% (VTE), from 1.8% to 2.9% (MACE), and from 66.6% to 76.1% (infections). Once on index treatment, overall incidence (P100PY) among the cohorts ranged from 6.9 to 8.9 (anemia), from 2.0 to 2.3 (malignancy), from 0.7 to 0.9 (VTE), from 1.6 to 2.0 (MACE), and from 77.4 to 87.7 (infections). The incident comorbidities (except herpes zoster) were associated with increased adjusted health care costs. Conclusion: Anemia, malignancy, VTE, MACE, and infections affect patients with RA at all stages of their treatment journey and are associated with increased health care costs. [ABSTRACT FROM AUTHOR]

Published
2022
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37. Autoantigen microarrays for multiplex characterization of autoantibody responses

Author

Robinson, William H., DiGennaro, Carla, Hueber, Wolfgang, Haab, Brian B., Kamachi, Makoto, Dean, Erik J., Fournel, Sylvie, Fong, Derek, Genovese, Mark C., de Vegvar, Henry E. Neuman, Skriner, Karl, Hirschberg, David L., Morris, Robert I., Muller, Sylviane, Pruijn, Ger J., van Venrooij, Walther J., Smolen, Josef S., Brown, Patrick O., Steinman, Lawrence, and Utz, Paul J.

Published
2002
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41. Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs

Author

Fleischmann, Roy, Cutolo, Maurizio, Genovese, Mark C., Lee, Eun Bong, Kanik, Keith S., Sadis, Seth, Connell, Carol A., Gruben, David, Krishnaswami, Sriram, Wallenstein, Gene, Wilkinson, Bethanie E., and Zwillich, Samuel H.

Published
2012
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42. Diminished cytokine-induced Jak/STAT signaling is associated with rheumatoid arthritis and disease activity

Author

Ptacek, Jason, primary, Hawtin, Rachael E., additional, Sun, Dongmei, additional, Louie, Brent, additional, Evensen, Erik, additional, Mittleman, Barbara B., additional, Cesano, Alessandra, additional, Cavet, Guy, additional, Bingham, Clifton O., additional, Cofield, Stacey S., additional, Curtis, Jeffrey R., additional, Danila, Maria I., additional, Raman, Chander, additional, Furie, Richard A., additional, Genovese, Mark C., additional, Robinson, William H., additional, Levesque, Marc C., additional, Moreland, Larry W., additional, Nigrovic, Peter A., additional, Shadick, Nancy A., additional, O’Dell, James R., additional, Thiele, Geoffrey M., additional, Clair, E. William St, additional, Striebich, Christopher C., additional, Hale, Matthew B., additional, Khalili, Houman, additional, Batliwalla, Franak, additional, Aranow, Cynthia, additional, Mackay, Meggan, additional, Diamond, Betty, additional, Nolan, Garry P., additional, Gregersen, Peter K., additional, and Bridges, S. Louis, additional

Published
2021
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48. Phase II, randomised, double-blind, multicentre study evaluating the safety and efficacy of filgotinib and lanraplenib in patients with lupus membranous nephropathy

Author

Baker, Matthew, primary, Chaichian, Yashaar, additional, Genovese, Mark, additional, Derebail, Vimal, additional, Rao, Panduranga, additional, Chatham, Winn, additional, Bubb, Michael, additional, Lim, Sam, additional, Hajian, Hooman, additional, Gurtovaya, Oksana, additional, Patel, Uptal, additional, and Tumlin, James, additional

Published
2020
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49. Association of High Serum Interleukin‐6 Levels With Severe Progression of Rheumatoid Arthritis and Increased Treatment Response Differentiating Sarilumab From Adalimumab or Methotrexate in a Post Hoc Analysis

Author

Boyapati, Anita, primary, Schwartzman, Sergio, additional, Msihid, Jérôme, additional, Choy, Ernest, additional, Genovese, Mark C., additional, Burmester, Gerd R., additional, Lam, Gordon, additional, Kimura, Toshio, additional, Sadeh, Jonathan, additional, Weinreich, David M., additional, Yancopoulos, George D., additional, and Graham, Neil M. H., additional

Published
2020
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50. Safety of ixekizumab in adult patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis: data from 21 clinical trials

Author

Genovese, Mark C, primary, Mysler, Eduardo, additional, Tomita, Tetsuya, additional, Papp, Kim A, additional, Salvarani, Carlo, additional, Schwartzman, Sergio, additional, Gallo, Gaia, additional, Patel, Himanshu, additional, Lisse, Jeffrey R, additional, Kronbergs, Andris, additional, Leage, Soyi Liu, additional, Adams, David H, additional, Xu, Wen, additional, Marzo-Ortega, Helena, additional, and Lebwohl, Mark G, additional

Published
2020
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