Influence of study characteristics on harm estimates from randomised controlled trials in patients with inflammatory arthritis receiving biological or synthetic antirheumatic drugs: a meta-epidemiological study

Authors: Berg, Johannes Iuel ^{1, 2, ⁎}, Nielsen, Sabrina Mai ^{1, 2}, Malm, Esben ^{1, 2}, Ioannidis, John P.A. ³, Furst, Daniel E. ⁴, Smolen, Josef S. ⁵, Taylor, Peter C. ⁶, Kristensen, Lars Erik ¹, Tarp, Simon ¹, Ellingsen, Torkell ², Christensen, Robin ^{1, 2}

Source: In Annals of the Rheumatic Diseases March 2025 84(3):398-408

Expert consensus statement on the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: 2024 update

Authors: Nash, Peter ¹, Kerschbaumer, Andreas ², Konzett, Victoria ², Aletaha, Daniel ², Dörner, Thomas ³, Fleischmann, Roy ⁴, McInnes, Iain ⁵, Primdahl, Jette ⁶, Sattar, Naveed ⁷, Tanaka, Yoshiya ⁸, Trauner, Michael ⁹, Winthrop, Kevin ¹⁰, de Wit, Maarten ¹¹, Askling, Johan ¹², Baraliakos, Xenofon ¹³, Boehncke, Wolf-Henning ^{14, 15}, Emery, Paul ¹⁶, Gossec, Laure ¹⁷, Isaacs, John D. ¹⁸, Krauth, Maria ¹⁹, Lee, Eun Bong ²⁰, Maksymowych, Walter ²¹, Pope, Janet ²², Scholte-Voshaar, Marieke ^{23, 24}, Schreiber, Karen ^{25, 26, 27}, Schreiber, Stefan ²⁸, Stamm, Tanja ²⁹, Taylor, Peter C. ³⁰, Takeuchi, Tsutomu ³¹, Tam, Lai-Shan ³², Van den Bosch, Filip ^{33, 34}, Westhovens, Rene ³⁵, Zeitlinger, Markus ³⁶, Smolen, Josef S. ^{2, ⁎}

Source: In Annals of the Rheumatic Diseases December 2024

Efficacy of Janus kinase inhibitors in immune-mediated inflammatory diseases a systematic literature review informing the 2024 update of an international consensus statement

Authors: Konzett, Victoria ^{1, ⁎}, Smolen, Josef S. ¹, Nash, Peter ², Aletaha, Daniel ¹, Winthrop, Kevin ³, Dörner, Thomas ⁴, Fleischmann, Roy ⁵, Tanaka, Yoshiya ⁶, Primdahl, Jette ⁷, Baraliakos, Xenofon ⁸, McInnes, Iain B. ⁹, Trauner, Michael ¹⁰, Sattar, Naveed ¹¹, de Wit, Maarten ¹², Schoones, Jan W. ¹³, Kerschbaumer, Andreas ¹

Source: In Annals of the Rheumatic Diseases November 2024

Safety of Janus kinase inhibitors in immune-mediated inflammatory diseases – a systematic literature review informing the 2024 update of an international expert consensus statement

Authors: Konzett, Victoria ^{1, ⁎}, Smolen, Josef S. ¹, Nash, Peter ², Winthrop, Kevin ³, Aletaha, Daniel ¹, Dörner, Thomas ⁴, Fleischmann, Roy ⁵, Tanaka, Yoshiya ⁶, Primdahl, Jette ⁷, Baraliakos, Xenofon ⁸, McInnes, Iain B. ⁹, Trauner, Michael ¹⁰, Sattar, Naveed ¹¹, de Wit, Maarten ¹², Schoones, Jan W. ¹³, Kerschbaumer, Andreas ¹

Source: In Annals of the Rheumatic Diseases November 2024

2023 International Consensus Guidance for the use of Tripterygium Wilfordii Hook F in the treatment of active rheumatoid arthritis

Authors: Zhang, Xuan, Xia, Jun, Jiang, Ying, Pisetsky, David S., Smolen, Josef S., Mu, Rong, Dai, Shengming, Weinblatt, Michael E., Kvien, Tore K., Li, Juan, Dörner, Thomas, Zhang, Yu, Lu, Liwei, Yang, Chengde, Yang, Pingting, Zhang, Yuan, Xu, Chenchen, Zhao, Zhan, Lipsky, Peter E.

Source: In Journal of Autoimmunity January 2024 142

Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study

Authors: Yu, Kyung-Sang, Kim, Byungwook, Shin, Dongseong, Park, Min Kyu, Hwang, Jun Gi, Kim, Min-Gul, Chung, Hyewon, Ghim, JongLyul, Chung, Jae-Yong, Smolen, Josef S., Burmester, Gerd R., Kim, SungHyun, Bae, YunJu, Jeon, DaBee, Yoo, JaeKyoung, Yang, GoEun, Bae, JiHun, Keystone, Edward

Source: Expert opinion on investigational drugs. 32(5):429-439

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100185046950.0x000001&indx=1&recIds=ETOCvdc_100185046950.0x000001

American College of Rheumatology/EULAR Remission Criteria for Rheumatoid Arthritis: 2022 Revision

Authors: Studenic, Paul, Aletaha, Daniel, Wit, Maarten, Stamm, Tanja A., Alasti, Farideh, Lacaille, Diane, Smolen, Josef S., Felson, David T.

Source: Arthritis & rheumatology. 75(1):15-22

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100175489490.0x000001&indx=1&recIds=ETOCvdc_100175489490.0x000001

Patient-defined flares and disease activity worsening in 222 patients with psoriatic arthritis from 14 countries

Authors: Sousa, Marlene, Lubrano, Ennio, Smolen, Josef S., Gorlier, Clémence, de Wit, Maarten, Coates, Laura C., Kalyoncu, Umut, Ruyssen-Witrand, Adeline, Leung, Ying-Ying, Scrivo, Rossana, Cañete, Juan D., Palominos, Penelope, Meisalu, Sandra, Balanescu, Andra, Kiltz, Uta, Aydin, Sibel Zehra, Gaydukova, Inna, Dernis, Emmanuelle, Fautrel, Bruno, Orbai, Ana-Maria, Gossec, Laure

Source: In Joint Bone Spine May 2023 90(3)

Accelerated waning of immune responses to a third COVID-19 vaccination in patients with immune-mediated inflammatory diseases

Authors: Mrak, Daniel, Kartnig, Felix, Sieghart, Daniela, Simader, Elisabeth, Radner, Helga, Mandl, Peter, Göschl, Lisa, Hofer, Philipp, Deimel, Thomas, Gessl, Irina, Kain, Renate, Winkler, Stefan, Smolen, Josef S., Perkmann, Thomas, Haslacher, Helmuth, Aletaha, Daniel, Heinz, Leonhard X., Bonelli, Michael

Source: In Journal of Autoimmunity February 2023 135

Comparison of disease activity index for psoriatic arthritis (DAPSA) and minimal disease activity (MDA) targets for patients with psoriatic arthritis: A post hoc analysis of data from phase 3 tofacitinib studies

Authors: Schneeberger, Emilce E., Citera, Gustavo, Nash, Peter, Smolen, Josef S., Mease, Philip J., Soriano, Enrique R., Helling, Claudia, Szumski, Annette E., Mundayat, Rajiv, de León, Darío Ponce

Source: In Seminars in Arthritis and Rheumatism February 2023 58

Torque Teno Virus quantification for monitoring of immunomodulation with biologic compounds in the treatment of rheumatoid arthritis

Authors: Studenic, Paul, Bond, Gregor, Kerschbaumer, Andreas, Bécède, Manuel, Pavelka, Karel, Karateev, Dmitry, Stieger, Jutta, Puchner, Rudolf, Mueller, Ruediger B, Puchhammer-Stöckl, Elisabeth, Durechova, Martina, Loiskandl, Michaela, Perkmann, Thomas, Olejarova, Martina, Luchikhina, Elena, Steiner, Carl-Walter, Bonelli, Michael, Smolen, Josef S, Aletaha, Daniel

Source: Rheumatology. 61(7):2815-2825

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100157060168.0x000001&indx=1&recIds=ETOCvdc_100157060168.0x000001

Implementing a Treat‐to‐Target Approach for Rheumatoid Arthritis During the COVID‐19 Pandemic: Results of a Virtual Learning Collaborative Program

Authors: Solomon, Daniel H., Pincus, Theodore, Shadick, Nancy A., Stratton, Jacklyn, Ellrodt, Jack, Santacroce, Leah, Katz, Jeffrey N., Smolen, Josef S.

Source: Arthritis care & research. 74(4):572-578

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100145472639.0x000001&indx=1&recIds=ETOCvdc_100145472639.0x000001

Patient Profiles in Randomized Controlled Trials Versus a Real-World Study in Psoriatic Arthritis: Scoping Review and Metaanalysis.

Authors: Alle, Gelsomina, Lopez-Medina, Clementina, Siebert, Stefan, Lavie, Frédéric, Noel, Wim, Smolen, Josef S., Gossec, Laure

Source: Journal of Rheumatology; Feb2025, Vol. 52 Issue 2, p138-144, 7p

Subject Terms: ANTIRHEUMATIC agents, BODY surface area, PSORIATIC arthritis, RANDOMIZED controlled trials, BIOTHERAPY

Considerations and priorities for incorporating the patient perspective on remission in rheumatoid arthritis: An OMERACT 2020 special interest group report

Authors: Jones, Bethan, Flurey, Caroline A, Proudman, Susanna, Ferreira, Ricardo J.O., Voshaar, Marieke, Hoogland, Wijnanda, Chaplin, Hema, Goel, Niti, Hetland, Merete Lund, Hill, Catherine, Kuriya, Bindee, Mather, Kate, Rasch, Linda, Shea, Beverley, Singh, Jasvinder A., Smolen, Josef S, da Silva, Jose AP, de Souza, Savia, Stamm, Tanja, Studenic, Paul, de Wit, Maarten, Tugwell, Peter, Boers, Maarten

Source: In Seminars in Arthritis and Rheumatism October 2021 51(5):1108-1112

OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

Authors: Nielsen, Sabrina Mai, Boers, Maarten, de Wit, Maarten, Shea, Beverly, van der Windt, Danielle A., Reeves, Barnaby C., Beaton, Dorcas, Alten, Rieke, Toupin April, Karine, Boonen, Annelies, Escorpizo, Reuben, Flurey, Caroline, Furst, Daniel E., Guillemin, Francis, Leong, Amye, Pohl, Christoph, Rasmussen, Marianne Uggen, Singh, Jasvinder A., Smolen, Josef S., Strand, Vibeke, Verstappen, Suzanne M.M., Voshaar, Marieke, Woodworth, Thasia G., Ellingsen, Torkell, March, Lyn, Wells, George A., Tugwell, Peter, Christensen, Robin

Source: In Seminars in Arthritis and Rheumatism June 2021 51(3):601-606

Comparing the Patient‐Reported Physical Function Outcome Measures in a Real‐Life International Cohort of Patients With Psoriatic Arthritis

Authors: Leung, Ying Ying, Orbai, Ana‐Maria, Wit, Maarten, Balanescu, Andra, Dernis, Emmanuelle, Soubrier, Martin, Eder, Lihi, Smolen, Josef S., Coates, Laura C., Gossec, Laure

Source: Arthritis care & research. 73(4):593-602

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100117469057.0x000001&indx=1&recIds=ETOCvdc_100117469057.0x000001

Efficacy and safety of Sandoz biosimilar rituximab for active rheumatoid arthritis: 52-week results from the randomized controlled ASSIST-RA trial

Authors: Smolen, Josef S, Cohen, Stanley B, Tony, Hans-Peter, Scheinberg, Morton, Kivitz, Alan, Balanescu, Andra, Gomez-Reino, Juan, Cen, Liyi, Poetzl, Johann, Shisha, Tamas, Kollins, Dmitrij

Source: Rheumatology. 60(1):256-262

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100170072313.0x000001&indx=1&recIds=ETOCvdc_100170072313.0x000001

Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis with 3 years of treatment: results from a long-term study

Authors: Smolen, Josef S, Xie, Li, Jia, Bochao, Taylor, Peter C, Burmester, Gerd, Tanaka, Yoshiya, Elias, Ayesha, Cardoso, Anabela, Ortmann, Rob, Walls, Chad, Dougados, Maxime

Source: Rheumatology. 60(5):2256-2266

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100131604996.0x000001&indx=1&recIds=ETOCvdc_100131604996.0x000001

Impact of high rheumatoid factor levels on treatment outcomes with certolizumab pegol and adalimumab in patients with rheumatoid arthritis.

Authors: Smolen, Josef S¹ josef.smolen@meduniwien.ac.at, Taylor, Peter C², Tanaka, Yoshiya³, Takeuchi, Tsutomu^4,5, Hashimoto, Motomu⁶, Cara, Carlos⁷, Lauwerys, Bernard⁸, Tilt, Nicola⁹, Ufuktepe, Baran¹⁰, Xavier, Ricardo M¹¹, Balsa, Alejandro¹², Curtis, Jeffrey R¹³, Mikuls, Ted R¹⁴, Weinblatt, Michael¹⁵

Source: Rheumatology. Nov2024, Vol. 63 Issue 11, p3015-3024. 10p.

Subject Terms: *ANTI-inflammatory agents, *CERTOLIZUMAB pegol, *DATA analysis, *PATIENT safety, *RESEARCH funding, *RHEUMATOID arthritis, *AUTOANTIBODIES, *STATISTICAL sampling, *BLIND experiment, *RANDOMIZED controlled trials, *DESCRIPTIVE statistics, *DRUG monitoring, *ADALIMUMAB, *DRUG efficacy, *STATISTICS, *COMPARATIVE studies

Olokizumab plus methotrexate: safety and efficacy over 106 weeks of treatment.

Authors: Feist, Eugen, Fleischmann, Roy M., Fatenejad, Saeed, Bukhanova, Daria, Grishin, Sergey, Kuzkina, Sofia, Luggen, Michael, Nasonov, Evgeniy, Samsonov, Mikhail, Smolen, Josef S.

Source: Annals of the Rheumatic Diseases; Nov2024, Vol. 83 Issue 11, p1454-1464, 214p