Search

Your search keyword '"Keystone, Edward C."' showing total 722 results
Start Over Author "Keystone, Edward C."
722 results on '"Keystone, Edward C."'

6. Rapid and sustained improvements in health-related quality of life, fatigue, and other patient-reported outcomes in rheumatoid arthritis patients treated with certolizumab pegol plus methotrexate over 1 year: results from the RAPID 1 randomized controlled trial

Author

Strand, Vibeke, Mease, Philip, Burmester, Gerd R, Nikaï, Enkeleida, Coteur, Geoffroy, van Vollenhoven, Ronald, Combe, Bernard, Keystone, Edward C, and Kavanaugh, Arthur

Abstract

Abstract Introduction The objective of this study was to assess the impact of certolizumab pegol (CZP) treatment on health-related quality of life (HRQoL), fatigue and other patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA). Methods Patients with active RA (N = 982) were randomized 2:2:1 to subcutaneous CZP (400 mg at weeks 0, 2 and 4; followed by CZP 200 mg or 400 mg) plus methotrexate (MTX) every other week, or placebo (PBO) plus MTX. PRO assessments included HRQoL, fatigue, physical function, arthritis pain and disease activity. Adjusted mean changes from baseline in all PROs were obtained using analysis of covariance (ANCOVA) applying last observation carried forward (LOCF) imputation. The proportion of patients achieving clinically meaningful improvements in each PRO was obtained using logistic regression and by applying non-responder imputation to missing values after rescue medication or withdrawal. The correlations between PRO responses and clinical responses were also assessed by tetrachoric correlation using non-responder imputation. Results Patients treated with CZP plus MTX reported significant (P < 0.001), clinically meaningful improvements in HRQoL at the first assessment (week 12); reductions in fatigue, disease activity and pain and improvements in physical function were reported at week 1. In particular, CZP-treated patients reported improvements in mental health. Mean changes from baseline in the SF-36 Mental Component Summary (MCS) at week 52 for CZP 200 mg and 400 mg plus MTX, and PBO plus MTX were 6.4, 6.4 and 2.1, respectively (P < 0.001). In addition, mental health and vitality scores in CZP-treated patients approached age- and gender-adjusted US population norms. Improvements in all PROs were sustained. Similar benefits were reported with both CZP doses. Changes in SF-36 MCS scores had the lowest correlation with disease activity scores (DAS28) and American College of Rheumatology 20% improvement (ACR20) response rates, while improvements in pain showed the highest correlation. Conclusions Treatment with CZP plus MTX resulted in rapid and sustained improvements in all PROs, indicating that the benefits of CZP extend beyond clinical efficacy endpoints into areas that are more relevant and meaningful for patients on a daily basis. Trial Registration ClinicalTrials.gov NCT00152386.

Published
2009

7. p53 tumor suppressor gene mutations in fibroblast-like synoviocytes from erosion synovium and non-erosion synovium in rheumatoid arthritis.

Author

Yamanishi, Yuji, Boyle, David L, Green, Douglas R, Keystone, Edward C, Connor, Alison, Zollman, Susan, and Firestein, Gary S

Subjects
Synovial Membrane, Cell Line, Clone Cells, Fibroblasts, Humans, Arthritis, Rheumatoid, Codon, Mutagenesis, Insertional, DNA Mutational Analysis, Sequence Deletion, Mutation, Missense, Point Mutation, Genes, p53, Matrix Metalloproteinase 1, erosion, fibroblast-like synoviocytes, invasiveness, p53 mutation, rheumatoid arthritis, Arthritis, Rheumatoid, Genes, p53, Mutagenesis, Insertional, Mutation, Missense, Clinical Sciences, Immunology, Public Health and Health Services, Arthritis & Rheumatology
Abstract

Abnormalities in the p53 tumor suppressor gene have been detected in rheumatoid arthritis (RA) and could contribute to the pathogenesis of chronic disease. To determine whether synoviocytes from invasive synovium in RA have an increased number of mutations compared with non-erosion synoviocytes, p53 cDNA subclones from fibroblast-like synoviocytes (FLS) derived from erosion and non-erosion sites of the same synovium were examined in patients requiring total joint replacement. Ten erosion FLS lines and nine non-erosion FLS lines were established from nine patients with RA. Exons 5-10 from 209 p53 subclones were sequenced (114 from erosion FLS, 95 from non-erosion FLS). Sixty percent of RA FLS cell lines and 8.6% of the p53 subclones isolated from FLS contained p53 mutations. No significant differences were observed between the erosion and non-erosion FLS with regard to the frequency or type of p53 mutation. The majority of the mutations were missense transition mutations, which are characteristic of oxidative damage. In addition, paired intact RA synovium and cultured FLS from the same joints were evaluated for p53 mutations. Matched synovium and cultured synoviocytes contained p53 mutations, although there was no overlap in the specific mutations identified in the paired samples. Clusters of p53 mutations in subclones were detected in some FLS, including one in codon 249, which is a well-recognized 'hot spot' associated with cancer. Our data are consistent with the hypothesis that p53 mutations are randomly induced by genotoxic exposure in small numbers of RA synoviocytes localized to erosion and non-erosion regions of RA synovium. The determining factor for invasiveness might be proximity to bone or cartilage rather than the presence of a p53 mutation.

Published
2005

9. Klinefelter's syndrome (47,XXY) is in excess among men with Sjögren's syndrome

Author

Harris, Valerie M., Sharma, Rohan, Cavett, Joshua, Kurien, Biji T., Liu, Ke, Koelsch, Kristi A., Rasmussen, Astrid, Radfar, Lida, Lewis, David, Stone, Donald U., Kaufman, C. Erick, Li, Shibo, Segal, Barbara, Wallace, Daniel J., Weisman, Michael H., Venuturupalli, Swamy, Kelly, Jennifer A., Alarcon-Riquelme, Marta E., Pons-Estel, Bernardo, Jonsson, Roland, Lu, Xianglan, Gottenberg, Jacques-Eric, Anaya, Juan-Manuel, Cunninghame-Graham, Deborah S., Huang, Andrew J.W., Brennan, Michael T., Hughes, Pamela, Alevizos, Ilias, Miceli-Richard, Corinne, Keystone, Edward C., Bykerk, Vivian P., Hirschfield, Gideon, Xie, Gang, Ng, Wan-Fai, Nordmark, Gunnel, Bucher, Sara Magnusson, Eriksson, Per, Omdal, Roald, Rhodus, Nelson L., Rischmueller, Maureen, Rohrer, Michael, Wahren-Herlenius, Marie, Witte, Torsten, Mariette, Xavier, Lessard, Christopher J., Harley, John B., Sivils, Kathy L., and Scofield, R. Hal

Published
2016
Full Text
View/download PDF

11. Safety and efficacy of filgotinib for Japanese patients with RA and inadequate response to MTX: FINCH 1 52-week results and FINCH 4 48-week results

Author

Tanaka, Yoshiya, primary, Matsubara, Tsukasa, additional, Atsumi, Tatsuya, additional, Amano, Koichi, additional, Ishiguro, Naoki, additional, Sugiyama, Eiji, additional, Yamaoka, Kunihiro, additional, Combe, Bernard G, additional, Kivitz, Alan J, additional, Bae, Sang-Cheol, additional, Keystone, Edward C, additional, Nash, Peter, additional, Genovese, Mark, additional, Matzkies, Franziska, additional, Bartok, Beatrix, additional, Pechonkina, Alena, additional, Kondo, Akira, additional, Ye, Lei, additional, Gong, Qi, additional, Tasset, Chantal, additional, and Takeuchi, Tsutomu, additional

Published
2022
Full Text
View/download PDF

14. Brief Report: Rare X Chromosome Abnormalities in Systemic Lupus Erythematosus and Sjögrenʼs Syndrome

Author

Sharma, Rohan, Harris, Valerie M., Cavett, Joshua, Kurien, Biji T., Liu, Ke, Koelsch, Kristi A., Fayaaz, Anum, Chaudhari, Kaustubh S., Radfar, Lida, Lewis, David, Stone, Donald U., Kaufman, C. Erick, Li, Shibo, Segal, Barbara, Wallace, Daniel J., Weisman, Michael H., Venuturupalli, Swamy, Kelly, Jennifer A., Pons‐Estel, Bernardo, Jonsson, Roland, Lu, Xianglan, Gottenberg, Jacques‐Eric, Anaya, Juan‐Manuel, Cunninghame‐Graham, Deborah S., Huang, Andrew J. W., Brennan, Michael T., Hughes, Pamela, Alevizos, Ilias, Miceli‐Richard, Corinne, Keystone, Edward C., Bykerk, Vivian P., Hirschfield, Gideon, Nordmark, Gunnel, Bucher, Sara Magnusson, Eriksson, Per, Omdal, Roald, Rhodus, Nelson L., Rischmueller, Maureen, Rohrer, Michael, Wahren‐Herlenius, Marie, Witte, Torsten, Alarcón‐Riquelme, Marta, Mariette, Xavier, Lessard, Christopher J., Harley, John B., Ng, Wan‐Fai, Rasmussen, Astrid, Sivils, Kathy L., and Scofield, R. Hal

Published
2017
Full Text
View/download PDF

15. Safety and efficacy of filgotinib for Japanese patients with RA and inadequate response to MTX: FINCH 1 52-week results and FINCH 4 48-week results.

Author

Tanaka, Yoshiya, Matsubara, Tsukasa, Atsumi, Tatsuya, Amano, Koichi, Ishiguro, Naoki, Sugiyama, Eiji, Yamaoka, Kunihiro, Combe, Bernard G., Kivitz, Alan J., Sang-Cheol Bae, Keystone, Edward C., Nash, Peter, Genovese, Mark, Matzkies, Franziska, Bartok, Beatrix, Pechonkina, Alena, Akira Kondo, Lei Ye, Qi Gong, and Tasset, Chantal

Subjects
JAPANESE people, FINCHES, RHEUMATOID arthritis, SAFETY
Abstract

Objectives: To present safety and efficacy of the JAK1 preferential inhibitor filgotinib in Japanese patients with prior inadequate response (IR) to methotrexate (MTX) from a 52-week randomised controlled parent study (PS) and long-term extension (LTE) through June 2020. Methods: The PS (NCT02889796) randomised MTX-IR patients to filgotinib 200 (FIL200) or 100 mg (FIL100), adalimumab (ADA) 40 mg, or placebo; all took stable background MTX. At week (W) 24, placebo patients were rerandomised to FIL200 or FIL100. The primary endpoint was W12 American College of Rheumatology 20% improvement; safety was assessed by adverse event (AE) reporting. For the LTE (NCT03025308), eligible filgotinib patients continued FIL200/FIL100; ADA patients were rerandomised (blinded) to FIL200 or FIL100; all continued MTX. Results: In all, 114/147 Japanese patients completed the PS, 115 enrolled in LTE, and 103 remained on study in June 2020. In the PS, AEs were consistent with the overall population, and W24 efficacy was maintained or improved through W52, comparable with the overall population. LTE AE incidences were similar between doses; filgotinib efficacy was consistent from baseline to W48 and similar between PS ADA and filgotinib patients. Conclusions: Among MTX-IR Japanese patients, filgotinib maintained efficacy over 1 year; LTE safety was consistent with the PS. [ABSTRACT FROM AUTHOR]

Published
2023
Full Text
View/download PDF

16. Future molecular targets

Author

Keystone, Edward C., Haraoui, Boulos, Parnham, Michael J., editor, Day, Richard O., editor, Fürst, Daniel E., editor, van Riel, Piet L. C. M., editor, and Bresnihan, Barry, editor

Published
2005
Full Text
View/download PDF

18. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis

Author

Taylor, Peter C., Keystone, Edward C., van der Heijde, Désirée, Weinblatt, Michael E., del Carmen Morales, Liliana, Gonzaga, Jaime Reyes, Yakushin, Sergey, Ishii, Taeko, Emoto, Kahaku, Beattie, Scott, Arora, Vipin, Gaich, Carol, Rooney, Terence, Schlichting, Douglas, Macias, William L., de Bono, Stephanie, and Tanaka, Yoshiya

Published
2017
Full Text
View/download PDF

19. Effectiveness and Safety of Tofacitinib in Canadian Patients With Rheumatoid Arthritis: Primary Results From a Prospective Observational Study.

Author

Haraoui, Boulos, Khraishi, Majed, Choquette, Denis, Lisnevskaia, Larissa, Teo, Michelle, Kinch, Cassandra, Galos, Corina, Roy, Patrice, Gruben, David, Woolcott, John C., Vaillancourt, Julie, Sampalis, John S., Keystone, Edward C., Pont, Karen, Chan, John, Jamal, Shahin, Baker, Milton, McCarthy, Timothy, Rahman, Al‐Amin Proton, and Sutton, Evelyn

Subjects
BLOOD sedimentation, LONGITUDINAL method, SCIENTIFIC observation, VISUAL analog scale
Abstract

Objective: The Canadian Tofacitinib for Rheumatoid Arthritis Observational (CANTORAL) is the first Canadian prospective, observational study assessing tofacitinib. The objective was to assess effectiveness and safety for moderate to severe rheumatoid arthritis (RA). Coprimary and secondary outcomes are reported from an interim analysis. Methods: Patients initiating tofacitinib from October 2017 to July 2020 were enrolled from 45 Canadian sites. Coprimary outcomes (month 6) included the Clinical Disease Activity Index (CDAI)–defined low disease activity (LDA) and remission. Secondary outcomes (to month 18) included the CDAI and the 4‐variable Disease Activity Score in 28 joints (DAS28) using the erythrocyte sedimentation rate (ESR)/C‐reactive protein (CRP) level to define LDA and remission; the proportions of patients achieving mild pain (visual analog scale <20 mm), and moderate (≥30%) and substantial (≥50%) pain improvements; and the proportions of patients achieving a Health Assessment Questionnaire disability index (HAQ DI) score greater or equal to normative values (≤0.25) and a HAQ DI score greater or equal to minimum clinically important difference (MCID) (≥0.22). Safety was assessed to month 36. Results: Of 504 patients initiating tofacitinib, 44.4% received concomitant methotrexate. At month 6, 52.9% and 15.4% of patients were in CDAI‐defined LDA and remission, respectively; a similar proportion of patients achieved outcomes by month 3 (first post‐baseline assessment). By month 3, 27.2% and 41.7% of patients, respectively, were in DAS28‐ESR–defined LDA and DAS28‐CRP <3.2; 14.7% and 25.8% achieved DAS28‐ESR remission and DAS28‐CRP <2.6. By month 3, mild pain and moderate and substantial pain improvements occurred in 29.6%, 55.6%, and 42.9% of patients, respectively; 19.9% and 53.7% of patients achieved a HAQ DI score greater than or equal to normative values and a HAQ DI score greater than or equal to MCID, respectively. Outcomes were generally maintained to month 18. Incidence rates (events per 100 patient‐years) for treatment‐emergent adverse events (AEs), serious AEs, and discontinuations due to AEs were 126.8, 11.9, and 14.5, respectively, and AEs of special interest were infrequent. Conclusion: Tofacitinib was associated with early and sustained improvement in RA signs and symptoms in real‐world patients. Effectiveness and safety were consistent with the established tofacitinib clinical profile. [ABSTRACT FROM AUTHOR]

Published
2023
Full Text
View/download PDF

21. Predictors of Influenza Vaccination in Early Rheumatoid Arthritis 2017‐2021: Results From the Canadian Early Arthritis Cohort

Author

Ta, Viviane, primary, Schieir, Orit, additional, Valois, Marie‐France, additional, Colmegna, Ines, additional, Hitchon, Carol, additional, Bessette, Louis, additional, Hazlewood, Glen, additional, Thorne, Carter, additional, Pope, Janet, additional, Boire, Gilles, additional, Tin, Diane, additional, Keystone, Edward C., additional, Bykerk, Vivian P., additional, and Bartlett, Susan J., additional

Published
2022
Full Text
View/download PDF

23. The comparative effectiveness of oral versus subcutaneous methotrexate for the treatment of early rheumatoid arthritis

Author

Hazlewood, Glen S, Thorne, J Carter, Pope, Janet E, Lin, Daming, Tin, Diane, Boire, Gilles, Haraoui, Boulos, Hitchon, Carol A, Keystone, Edward C, Jamal, Shahin, Bykerk, Vivian P, Khraishi, Majed, Villeneuve, Edith, Baron, Murray, Colmegna, Ines, Bartlett, Susan, Zummer, Michel, Akhavan, Pooneh, Rubin, Lawrence, Kuriya, Bindee, Ahluwahlia, Vandana, Bensen, William, Larche, Maggie, Barra, Lillian, Nair, Bindu, Penney, Christopher, Mosher, Dianne, Barnabe, Cheryl, Arbillaga, Hector, Lyddell, Christopher, Klinkhoff, Alice, Sniderman, Franci, Wang, Jim, and Scientific, McDougall

Published
2016
Full Text
View/download PDF

24. X Chromosome Dose and Sex Bias in Autoimmune Diseases: Increased Prevalence of 47,XXX in Systemic Lupus Erythematosus and Sjögrenʼs Syndrome

Author

Liu, Ke, Kurien, Biji T., Zimmerman, Sarah L., Kaufman, Kenneth M., Taft, Diana H., Kottyan, Leah C., Lazaro, Sara, Weaver, Carrie A., Ice, John A., Adler, Adam J., Chodosh, James, Radfar, Lida, Rasmussen, Astrid, Stone, Donald U., Lewis, David M., Li, Shibo, Koelsch, Kristi A., Igoe, Ann, Talsania, Mitali, Kumar, Jay, Maier-Moore, Jacen S., Harris, Valerie M., Gopalakrishnan, Rajaram, Jonsson, Roland, Lessard, James A., Lu, Xianglan, Gottenberg, Jacques-Eric, Anaya, Juan-Manuel, Cunninghame-Graham, Deborah S., Huang, Andrew J. W., Brennan, Michael T., Hughes, Pamela, Illei, Gabor G., Miceli-Richard, Corinne, Keystone, Edward C., Bykerk, Vivian P., Hirschfield, Gideon, Xie, Gang, Ng, Wan-Fai, Nordmark, Gunnel, Eriksson, Per, Omdal, Roald, Rhodus, Nelson L., Rischmueller, Maureen, Rohrer, Michael, Segal, Barbara M., Vyse, Timothy J., Wahren-Herlenius, Marie, Witte, Torsten, Pons-Estel, Bernardo, Alarcón-Riquelme, Marta E., Guthridge, Joel M., James, Judith A., Lessard, Christopher J., Kelly, Jennifer A., Thompson, Susan D., Gaffney, Patrick M., Montgomery, Courtney G., Edberg, Jeffrey C., Kimberly, Robert P., Alarcón, Graciela S., Langefeld, Carl L., Gilkeson, Gary S., Kamen, Diane L., Tsao, Betty P., McCune, Joseph W., Salmon, Jane E., Merrill, Joan T., Weisman, Michael H., Wallace, Daniel J., Utset, Tammy O., Bottinger, Erwin P., Amos, Christopher I., Siminovitch, Katherine A., Mariette, Xavier, Sivils, Kathy L., Harley, John B., and Scofield, Hal R.

Published
2016
Full Text
View/download PDF

27. Efficacy and safety of filgotinib in combination with methotrexate in Japanese patients with active rheumatoid arthritis who have an inadequate response to methotrexate: Subpopulation analyses of 24-week data of a global phase 3 study (FINCH 1)

Author

Tanaka, Yoshiya, primary, Matsubara, Tsukasa, additional, Atsumi, Tatsuya, additional, Amano, Koichi, additional, Ishiguro, Naoki, additional, Sugiyama, Eiji, additional, Yamaoka, Kunihiro, additional, Combe, Bernard G, additional, Kivitz, Alan J, additional, Bae, Sang-Cheol, additional, Keystone, Edward C, additional, Nash, Peter, additional, Matzkies, Franziska, additional, Bartok, Beatrix, additional, Pechonkina, Alena, additional, Kondo, Akira, additional, Ye, Lei, additional, Guo, Ying, additional, Tasset, Chantal, additional, Sundy, John S, additional, and Takeuchi, Tsutomu, additional

Published
2021
Full Text
View/download PDF

31. Efficacy and safety of tofacitinib modified-release 11 mg once daily plus methotrexate in adult patients with rheumatoid arthritis: 24-week open-label phase results from a phase 3b/4 methotrexate withdrawal non-inferiority study (ORAL Shift)

Author

Cohen, Stanley B, primary, Pope, Janet, additional, Haraoui, Boulos, additional, Mysler, Eduardo, additional, Diehl, Annette, additional, Lukic, Tatjana, additional, Liu, Shixue, additional, Stockert, Lori, additional, Germino, Rebecca, additional, Menon, Sujatha, additional, Shi, Harry, additional, and Keystone, Edward C, additional

Published
2021
Full Text
View/download PDF

32. Primary and secondary non-response: in need of operational definitions in observational studies

Author

Vallejo-Yagüe, Enriqueta, Keystone, Edward C, Kandhasamy, Sreemanjari, Micheroli, Raphael, Finckh, Axel, and Burden, Andrea Michelle

Subjects
ddc:616, rheumatoid arthritis, Epidemiology, Arthritis, Rheumatoid, Observational Studies as Topic, Viewpoint, biological therapy, Research Design, Antirheumatic Agents, Humans, Biological therapy, epidemiology, Rheumatoid arthritis
Abstract

Annals of the Rheumatic Diseases, 80 (8), ISSN:0003-4967, ISSN:1468-2060

Published
2021
Full Text
View/download PDF

39. Additional file 1 of Radiographic progression based on baseline characteristics from TNF inhibitor biosimilar studies in patients with rheumatoid arthritis

Author

Smolen, Josef S., Kang, Young Mo, Wan-Hee Yoo, Emery, Paul, Weinblatt, Michael E., Keystone, Edward C., Genovese, Mark C., Gihyun Myung, Inyoung Baek, and Jeehoon Ghil

Abstract

Additional file 1 : Table S1. Disease activity cut-off values. Fig. S1A. Predicted probability (with 95% confidence limits) of patients with radiographic progression (yes/no) based on CDAI. B. Predicted probability (with 95% confidence limits) of patients with radiographic progression (yes/no) based on SDAI. Fig. S2A. Matrix model of the proportion of patients with joint erosion score > 0 based on SJC28, CRP, and PhGA. Data are presented as % (95% confidence interval). Predicted probability of patients represented by shading: green, 25.0%. B. Matrix model of the proportion of patients with joint space narrowing > 0 based on SJC28, CRP, and PhGA. Data are presented as % (95% confidence interval). Predicted probability of patients represented by shading: green, 21.0%. Fig. S3A. Matrix model of the proportion of patients in remission or low disease activity by SDAI at week 24/30 based on SJC28, CRP, and PhGA. Data are presented as % (95% confidence interval). Predicted probability of patients in remission with low disease activity represented by shading: green, > 47.0%; yellow, 40.0–47.0%; red, 32.0%; yellow, 27.0–32.0%; red

Published
2020
Full Text
View/download PDF

40. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial

Author

Combe, Bernard, primary, Kivitz, Alan, additional, Tanaka, Yoshiya, additional, van der Heijde, Désirée, additional, Simon, J Abraham, additional, Baraf, Herbert S B, additional, Kumar, Uma, additional, Matzkies, Franziska, additional, Bartok, Beatrix, additional, Ye, Lei, additional, Guo, Ying, additional, Tasset, Chantal, additional, Sundy, John S, additional, Jahreis, Angelika, additional, Genovese, Mark C, additional, Mozaffarian, Neelufar, additional, Landewé, Robert B M, additional, Bae, Sang-Cheol, additional, Keystone, Edward C, additional, and Nash, Peter, additional

Published
2021
Full Text
View/download PDF

41. RA in primary care: 20 Clinical pearls: making an earlier diagnosis, sorting out the newer drug therapies

Author

Bykerk, Vivian P. and Keystone, Edward C.

Subjects
Arthritis -- Diagnosis -- Research, Methotrexate -- Health aspects -- Research, Drug therapy -- Research -- Health aspects, Rheumatoid arthritis -- Diagnosis -- Research, Health, Diagnosis, Research, Health aspects
Abstract

ABSTRACT: Expedited diagnosis and management of rheumatoid arthritis (RA) early in the disease course has been shown to result in more favorable patient outcomes. Primary care physicians can be valuable [...]

Published
2004

46. Anti-tumour necrosis factor agents and tuberculosis risk: mechanisms of action and clinical management

Author

Gardam, Michael A., Keystone, Edward C., Menzies, Richard, Manners, Steven, Skamene, Emil, Long, Richard, and Vinh, Donald C.

Subjects
Tuberculosis -- Development and progression, Tuberculosis -- Risk factors, Bacterial infections -- Development and progression, Bacterial infections -- Risk factors, Necrosis -- Development and progression, Necrosis -- Risk factors, Immunotherapy
Published
2003

47. Efficacy and safety of filgotinib in combination with methotrexate in Japanese patients with active rheumatoid arthritis who have an inadequate response to methotrexate: Subpopulation analyses of 24-week data of a global phase 3 study (FINCH 1).

Author

Yoshiya Tanaka, Tsukasa Matsubara, Tatsuya Atsumi, Koichi Amano, Naoki Ishiguro, Eiji Sugiyama, Kunihiro Yamaoka…AUS-Department of Rheumatology and Infectious Diseases,Kitasato University School of Medicine, Kanagawa, Japan, Combe, Bernard G., Kivitz, Alan J., Sang-Cheol Bae, Keystone, Edward C., Nash, Peter, Matzkies, Franziska, Bartok, Beatrix, Pechonkina, Alena, Akira Kondo, Lei Ye, Ying Guo, Tasset, Chantal, and Sundy, John S.

Abstract

Objectives: Evaluate the efficacy and safety of the Janus kinase-1 inhibitor filgotinib in Japanese patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX). Methods: Data from 147 Japanese patients in FINCH 1, a 52-week global Phase 3 study, were analysed up to 24weeks. Patients received once-daily filgotinib 200 or 100 mg, biweekly adalimumab, or placebo, all with stable background MTX. Results: In the Japanese population, American College of Rheumatology 20% response rates at Week 12 (primary endpoint) were 77.5%, 65.9%, 53.6%, and 36.8% for filgotinib 200 mg, filgotinib 100 mg, adalimumab, and placebo. Proportions of patients achieving Disease Activity Score with 28 joints <2.6 at Week 24: filgotinib 200 mg, 65.0%; filgotinib 100 mg, 51.2%; adalimumab, 42.9%; and placebo, 5.3%. Incidence rates of serious infections: filgotinib 200mg, 2.5%; filgotinib 100mg, 0%; adalimumab, 10.7%; and placebo, 5.3%. Treatment-emergent laboratory abnormalities Grade ≥3 occurred in five (12.5%) filgotinib 200mg, three (7.3%) filgotinib 100mg, one (3.6%) adalimumab, and no placebo patients. No deaths were reported among Japanese patients. Conclusions: Filgotinib once daily combined with MTX was effective and generally safe and well tolerated up to Week 24 in Japanese patients with RA and inadequate response to MTX. [ABSTRACT FROM AUTHOR]

Published
2022
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results