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  1. Article ; Online: Long-term safety and efficacy of filgotinib treatment for rheumatoid arthritis in Japanese patients naïve to MTX treatment (FINCH 3).

    Atsumi, Tatsuya / Tanaka, Yoshiya / Matsubara, Tsukasa / Amano, Koichi / Ishiguro, Naoki / Sugiyama, Eiji / Yamaoka, Kunihiro / Westhovens, René / Ching, Daniel W T / Messina, Osvaldo Daniel / Burmester, Gerd R / Genovese, Mark / Bartok, Beatrix / Pechonkina, Alena / Kondo, Akira / Yin, Zhaoyu / Gong, Qi / Tasset, Chantal / Takeuchi, Tsutomu

    Modern rheumatology

    2022  Volume 33, Issue 4, Page(s) 657–667

    Abstract: Objectives: To evaluate the long-term safety and efficacy of filgotinib (FIL) for Japanese patients with rheumatoid arthritis (RA) and limited/no prior methotrexate (MTX) exposure. We present a Japanese population subanalysis of a global randomised- ... ...

    Abstract Objectives: To evaluate the long-term safety and efficacy of filgotinib (FIL) for Japanese patients with rheumatoid arthritis (RA) and limited/no prior methotrexate (MTX) exposure. We present a Japanese population subanalysis of a global randomised-controlled trial at Week 52 and interim long-term extension (LTE) to Week 48 through June 2020.
    Methods: Patients were randomised to FIL 200 mg plus MTX, FIL 100 mg plus MTX, FIL 200 mg, or MTX for 52 weeks. At completion, eligible patients could enrol in the LTE. Those receiving FIL continued; those receiving MTX were rerandomised (blinded) to FIL 200 or 100 mg upon discontinuation of MTX. After a 4-week washout period, MTX could be re-added.
    Results: Adverse event rates at Week 52 and in the LTE to Week 48 were comparable across treatment groups. Week 52 American College of Rheumatology 20% improvement (ACR20) rates were 83% (19/23), 82% (9/11), 75% (9/12), and 76% (19/25) for FIL 200 mg plus MTX, FIL 100 mg plus MTX, FIL 200 mg, and MTX, respectively. Through LTE Week 48, ACR20 rates were maintained.
    Conclusions: In the 56 Japanese patients treated with FIL, efficacy was maintained through Week 52 and beyond, with no increases in the incidence of adverse events.
    MeSH term(s) Animals ; Humans ; Antirheumatic Agents/adverse effects ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Double-Blind Method ; Drug Therapy, Combination ; East Asian People ; Methotrexate/adverse effects ; Treatment Outcome
    Chemical Substances Antirheumatic Agents ; GLPG0634 ; Methotrexate (YL5FZ2Y5U1)
    Language English
    Publishing date 2022-07-28
    Publishing country England
    Document type Randomized Controlled Trial ; Journal Article
    ZDB-ID 2078157-X
    ISSN 1439-7609 ; 1439-7595
    ISSN (online) 1439-7609
    ISSN 1439-7595
    DOI 10.1093/mr/roac083
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Efficacy and safety of filgotinib alone and in combination with methotrexate in Japanese patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: Subpopulation analyses of 24-week data of a global phase 3 study (FINCH 3).

    Atsumi, Tatsuya / Tanaka, Yoshiya / Matsubara, Tsukasa / Amano, Koichi / Ishiguro, Naoki / Sugiyama, Eiji / Yamaoka, Kunihiro / Westhovens, René / Ching, Daniel W T / Messina, Osvaldo Daniel / Burmester, Gerd R / Bartok, Beatrix / Pechonkina, Alena / Kondo, Akira / Yin, Zhaoyu / Guo, Ying / Tasset, Chantal / Sundy, John S / Takeuchi, Tsutomu

    Modern rheumatology

    2021  Volume 32, Issue 2, Page(s) 273–283

    Abstract: Objectives: To evaluate the efficacy and safety of filgotinib for Japanese patients with rheumatoid arthritis (RA) and limited or no prior methotrexate (MTX) exposure.: Methods: Data up to 24 weeks were analysed for 71 Japanese patients from a 52- ... ...

    Abstract Objectives: To evaluate the efficacy and safety of filgotinib for Japanese patients with rheumatoid arthritis (RA) and limited or no prior methotrexate (MTX) exposure.
    Methods: Data up to 24 weeks were analysed for 71 Japanese patients from a 52-week global Phase 3 study. Patients with RA and limited or no prior MTX exposure were randomised in a 2:1:1:2 ratio to filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, or MTX. Maximum MTX dose was 15 mg/week. Primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 24.
    Results: Week 24 ACR20 rates in Japanese patients were 82.6%, 90.9%, 83.3%, and 80.0% for filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, and MTX, respectively. Greater ACR20 rates with filgotinib vs MTX occurred at Week 2. Greater proportions receiving filgotinib vs MTX achieved DAS28-CRP <2.6 at Weeks 12 and 24. Adverse event rates were comparable across treatments and between the Japanese and overall populations.
    Conclusions: While Week 24 ACR20 rates were similar, filgotinib provided faster responses and higher remission rates vs MTX. In Japanese patients with RA and limited or no prior MTX exposure, filgotinib was generally well tolerated.
    MeSH term(s) Animals ; Antirheumatic Agents/adverse effects ; Arthritis, Rheumatoid/drug therapy ; Double-Blind Method ; Drug Therapy, Combination ; Finches ; Humans ; Japan ; Methotrexate/adverse effects ; Pyridines ; Treatment Outcome ; Triazoles
    Chemical Substances Antirheumatic Agents ; GLPG0634 ; Pyridines ; Triazoles ; Methotrexate (YL5FZ2Y5U1)
    Language English
    Publishing date 2021-12-15
    Publishing country England
    Document type Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
    ZDB-ID 2078157-X
    ISSN 1439-7609 ; 1439-7595
    ISSN (online) 1439-7609
    ISSN 1439-7595
    DOI 10.1093/mr/roab021
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial.

    Westhovens, René / Rigby, William F C / van der Heijde, Désirée / Ching, Daniel W T / Stohl, William / Kay, Jonathan / Chopra, Arvind / Bartok, Beatrix / Matzkies, Franziska / Yin, Zhaoyu / Guo, Ying / Tasset, Chantal / Sundy, John S / Jahreis, Angelika / Mozaffarian, Neelufar / Messina, Osvaldo Daniel / Landewé, Robert Bm / Atsumi, Tatsuya / Burmester, Gerd R

    Annals of the rheumatic diseases

    2021  Volume 80, Issue 6, Page(s) 727–738

    Abstract: Objectives: To investigate efficacy and safety of the Janus kinase-1 inhibitor filgotinib in patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure.: Methods: This 52-week, phase 3, multicentre, double- ... ...

    Abstract Objectives: To investigate efficacy and safety of the Janus kinase-1 inhibitor filgotinib in patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure.
    Methods: This 52-week, phase 3, multicentre, double-blind clinical trial (NCT02886728) evaluated once-daily oral filgotinib in 1252 patients with RA randomised 2:1:1:2 to filgotinib 200 mg with MTX (FIL200 +MTX), filgotinib 100 mg with MTX (FIL100 +MTX), filgotinib 200 mg monotherapy (FIL200), or MTX. The primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 24.
    Results: The primary endpoint was achieved by 81% of patients receiving FIL200+ MTX versus 71% receiving MTX (p<0.001). A significantly greater proportion treated with FIL100+ MTX compared with MTX achieved an ACR20 response (80%, p=0.017) at week 24. Significant improvement in Health Assessment Questionnaire-Disability Index was seen at week 24; least-squares mean change from baseline was -1.0 and -0.94 with FIL200+MTX and FIL100+MTX, respectively, versus -0.81 with MTX (p<0.001, p=0.008, respectively). Significantly higher proportions receiving FIL200+MTX (54%) and FIL100+MTX (43%) achieved DAS28(CRP) <2.6 versus MTX (29%) (p<0.001 for both) at week 24. Hierarchical testing stopped for comparison of ACR20 for FIL200 monotherapy (78%) versus MTX (71%) at week 24 (p=0.058). Adverse event rates through week 52 were comparable between all treatments.
    Conclusions: FIL200+MTX and FIL100+MTX both significantly improved signs and symptoms and physical function in patients with active RA and limited or no prior MTX exposure; FIL200 monotherapy did not have a superior ACR20 response rate versus MTX. Filgotinib was well tolerated, with acceptable safety compared with MTX.
    MeSH term(s) Animals ; Antirheumatic Agents/adverse effects ; Arthritis, Rheumatoid/diagnosis ; Double-Blind Method ; Drug Therapy, Combination ; Finches ; Humans ; Methotrexate/therapeutic use ; Pyridines ; Treatment Outcome ; Triazoles
    Chemical Substances Antirheumatic Agents ; GLPG0634 ; Pyridines ; Triazoles ; Methotrexate (YL5FZ2Y5U1)
    Language English
    Publishing date 2021-01-15
    Publishing country England
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 7090-7
    ISSN 1468-2060 ; 0003-4967
    ISSN (online) 1468-2060
    ISSN 0003-4967
    DOI 10.1136/annrheumdis-2020-219213
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Successful treatment with low-dose thalidomide in a patient with both Behçet's disease and complex regional pain syndrome type I: case report.

    Ching, Daniel W T / McClintock, Alan / Beswick, Frances

    Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases

    2003  Volume 9, Issue 2, Page(s) 96–98

    Abstract: Thalidomide is a recognized treatment of Behçet's disease. Low-dose thalidomide seems to be effective in the treatment of orogenital ulcers and is potentially safer with a lower incidence of adverse effects than higher doses. We wish to report a case of ... ...

    Abstract Thalidomide is a recognized treatment of Behçet's disease. Low-dose thalidomide seems to be effective in the treatment of orogenital ulcers and is potentially safer with a lower incidence of adverse effects than higher doses. We wish to report a case of Behçet's disease in a 33-year-old woman who responded well to thalidomide 50 mg 2 to 4 times per week. Her disease manifestations (severe orogenital ulceration, pseudofolliculitis, mild thrombophlebitis, positive pathergy response, and fatigue) were previously resistant to courses of prednisone, dapsone, colchicine, various types of mouthwash, and topical steroid preparations. She also gave a history of complex regional pain syndrome type I (CRPS 1) over her left patella (severe pain, intermittent edema, hyperalgesia, allodynia, cold skin, and loss of movement) after a fall onto her left knee 6 years previously. This had only partially responded to a variety of treatment modalities. After starting thalidomide for her Behçet's disease, the pain in her left knee unexpectedly disappeared. There are rat experiments showing that thalidomide improves neuropathic pain, probably by selectively blocking tumor necrosis factor-alpha production in activated macrophages. We believe this is the first report of successful use of thalidomide in a human being with CRPS 1, and we therefore recommend that thalidomide should be considered in the treatment of CRPS 1.
    Language English
    Publishing date 2003-04
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1283266-2
    ISSN 1076-1608
    ISSN 1076-1608
    DOI 10.1097/01.RHU.0000062620.10630.21
    Database MEDical Literature Analysis and Retrieval System OnLINE

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