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  1. Article ; Online: An Insight into Patients' Perspectives of Ulcerative Colitis Flares via Analysis of Online Public Forum Posts.

    Rubin, David T / Torres, Joana / Dotan, Iris / Xu, Lan Terry / Modesto, Irene / Woolcott, John C / Gardiner, Sean / Sands, Bruce E

    Inflammatory bowel diseases

    2023  

    Abstract: Background: The knowledge of patients' perceptions of factors contributing to ulcerative colitis (UC) flares is limited; however, online patient communications could offer insight. This analysis aimed to identify the most frequent patient-reported ... ...

    Abstract Background: The knowledge of patients' perceptions of factors contributing to ulcerative colitis (UC) flares is limited; however, online patient communications could offer insight. This analysis aimed to identify the most frequent patient-reported triggers and symptoms of UC flares, which could highlight potential interventions for outcome improvement.
    Methods: Online posts written pre- and postflare by patients with UC on 8 public forums in 6 countries between January 1, 2019, and February 14, 2021, were identified using flare-related keywords. Flare-related posts were captured and Netbase Quid™ artificial intelligence text analytics and natural language processing software were used to semantically map and identify commonly discussed themes and topics (subsets of themes).
    Results: Of >27 000 patient posts, 12 900 were identified as flare related. The most frequent themes were treatment experiences and side effects (28.5% of posts), followed by flare symptoms (22.9% of posts). The most frequent topic was emotional/peer support (9.4% of posts), followed by experiences with mesalamine (and other oral/rectal formulations; 8.0% of posts), and dietary recommendations (6.0% of posts). Stress and anxiety were the most frequently reported flare triggers (37.9% of posts), followed by diet (28.4% of posts). Stress and anxiety were frequently identified as both triggers for, and general symptoms of, flare. Blood in the stool was the most discussed flare indicator (57.8% of posts).
    Conclusions: Frequently discussed patient-perceived triggers of UC flares included diet, stress, and anxiety. These results suggest that physicians could incorporate a broader and more holistic approach to UC monitoring and management than is currently practiced.
    Language English
    Publishing date 2023-11-02
    Publishing country England
    Document type Journal Article
    ZDB-ID 1340971-2
    ISSN 1536-4844 ; 1078-0998
    ISSN (online) 1536-4844
    ISSN 1078-0998
    DOI 10.1093/ibd/izad247
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  2. Article ; Online: Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program.

    Hudesman, David P / Torres, Joana / Salese, Leonardo / Woolcott, John C / Mundayat, Rajiv / Su, Chinyu / Mosli, Mahmoud H / Allegretti, Jessica R

    The patient

    2022  Volume 16, Issue 2, Page(s) 95–103

    Abstract: Background: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). The tofacitinib OCTAVE clinical program included phase III induction (OCTAVE Induction 1 and 2) and maintenance (OCTAVE Sustain) ... ...

    Abstract Background: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). The tofacitinib OCTAVE clinical program included phase III induction (OCTAVE Induction 1 and 2) and maintenance (OCTAVE Sustain) studies, and an open-label, long-term extension study (OCTAVE Open).
    Objective: This post hoc analysis assessed selected long-term, disease-specific patient-reported outcome (PRO) and health-related quality-of-life (HRQoL) measurements in patients with UC receiving tofacitinib in the OCTAVE clinical program.
    Methods: Analyses included patients from OCTAVE Open assigned to tofacitinib 5 mg twice daily (subpopulation in remission at Week 52 of OCTAVE Sustain). OCTAVE Open data from the final analyses are shown to Month 48. Endpoints included rectal bleeding subscore (RBS) = 0, stool frequency subscore (SFS) ≤ 1, and HRQoL measure, Inflammatory Bowel Disease Questionnaire (IBDQ) remission (IBDQ total score ≥ 170); with non-responder imputation for missing data at all visits, and last observation carried forward for visits after a patient advanced to the next study (NRI-LOCF). Observed cases were also assessed.
    Results: At Month 48, of 175 patients, 95 (54.3%) and 96 (54.9%) achieved/maintained RBS = 0 and SFS ≤ 1, respectively (NRI-LOCF). Additionally, 93 (53.1%) patients achieved/maintained IBDQ remission at Month 48 (NRI-LOCF).
    Conclusions: Among patients who entered OCTAVE Open in remission, most maintained normalization of rectal bleeding and improvement in stool frequency for ≤ 4 years of follow-up in OCTAVE Open. IBDQ remission was also generally maintained in OCTAVE Open. These data show robust maintenance of key UC PROs and durability of response with tofacitinib 5 mg twice daily.
    Trial registration: http://www.
    Clinicaltrials: gov (NCT01465763 [21/10/2011]; NCT01458951 [21/10/2011]; NCT01458574 [21/10/2011]; NCT01470612 [21/10/2011]).
    MeSH term(s) Humans ; Colitis, Ulcerative/drug therapy ; Piperidines/adverse effects ; Pyrimidines/adverse effects ; Quality of Life ; Remission Induction ; Treatment Outcome
    Chemical Substances Piperidines ; Pyrimidines ; tofacitinib (87LA6FU830)
    Language English
    Publishing date 2022-11-07
    Publishing country New Zealand
    Document type Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2466680-4
    ISSN 1178-1661 ; 1178-1653
    ISSN (online) 1178-1661
    ISSN 1178-1653
    DOI 10.1007/s40271-022-00603-w
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  3. Article ; Online: Persistence of treatment in patients with ulcerative colitis who responded to tofacitinib therapy: data from the open-label, long-term extension study, OCTAVE open.

    Panaccione, Remo / Abreu, Maria T / Lazariciu, Irina / Mundayat, Rajiv / Lawendy, Nervin / Salese, Leonardo / Woolcott, John C / Sands, Bruce E / Chaparro, María

    Alimentary pharmacology & therapeutics

    2022  Volume 55, Issue 12, Page(s) 1534–1544

    MeSH term(s) Colitis, Ulcerative/chemically induced ; Colitis, Ulcerative/drug therapy ; Humans ; Longitudinal Studies ; Piperidines/therapeutic use ; Pyrimidines/therapeutic use ; Pyrroles/therapeutic use
    Chemical Substances Piperidines ; Pyrimidines ; Pyrroles ; tofacitinib (87LA6FU830)
    Language English
    Publishing date 2022-03-05
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 639012-2
    ISSN 1365-2036 ; 0269-2813 ; 0953-0673
    ISSN (online) 1365-2036
    ISSN 0269-2813 ; 0953-0673
    DOI 10.1111/apt.16848
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    Zs.A 2206: Show issues Location:
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  4. Article ; Online: Histological Outcomes And Jak-Stat Signalling In Ulcerative Colitis Patients Treated With Tofacitinib.

    van Gennep, Sara / Fung, Ivan C N / de Jong, Djuna C / Ramkisoen, Rishand K / Clasquin, Esmé / de Jong, Jitteke / de Vries, Leonie C S / de Jonge, Wouter J / Gecse, Krisztina B / Löwenberg, Mark / Woolcott, John C / Mookhoek, Aart / D'Haens, Geert R

    Journal of Crohn's & colitis

    2024  

    Abstract: Background and aims: Histological outcomes and JAK-STAT signaling were assessed in a prospective ulcerative colitis (UC) patient cohort after 8 weeks treatment with tofacitinib, an oral Janus kinase (JAK) inhibitor.: Methods: Forty UC patients ... ...

    Abstract Background and aims: Histological outcomes and JAK-STAT signaling were assessed in a prospective ulcerative colitis (UC) patient cohort after 8 weeks treatment with tofacitinib, an oral Janus kinase (JAK) inhibitor.
    Methods: Forty UC patients received tofacitinib 10 mg twice daily for 8 weeks. Treatment response was defined as histo-endoscopic mucosal improvement (HEMI). Histological remission was defined as a Robarts Histopathology Index (RHI) ≤3 points and histological response as 50% decrease in RHI. Mucosal expression of JAK1-3, Tyrosine kinase 2 (TYK2) and total signal transducer and activator of transcription (STAT) 1-6 were assessed using immunohistochemistry (IHC).
    Results: At baseline, the median RHI was 14 (interquartile range (IQR) 10-19). Twenty-six of 40 (65%) patients had severe endoscopic disease (endoscopic Mayo score 3) and 31/40 (78%) failed prior anti-TNF treatment. At week 8, 15 patients (38%) had HEMI, 23 patients (58%) histological remission and 34 (85%) histological response. RHI decreased by a median of 14 points (IQR 9-21) in responders (p<0.001) and by 6 points (IQR 0-13) in non-responders (p=0.002). STAT1, STAT3 and STAT5 expression levels decreased significantly in the whole cohort. Responders had lower week 8 STAT1 expression levels compared to non-responders (0.2%, IQR 0.1-2.8 vs 4.3%, IQR 1.2-11.9, p=0.001), suggesting more profound STAT1 blockade. A trend of higher baseline JAK2 expression was observed in tofacitinib non-responders (2.7%, IQR 0.1-7.7) compared to responders (0.4%, IQR 0.1-2.1).
    Conclusions: Tofacitinib treatment resulted in histological improvement in the majority of UC patients and a substantial decrease of STAT1, STAT3 and STAT5 expression. HEMI was associated with more profound suppression of STAT1.
    Language English
    Publishing date 2024-03-20
    Publishing country England
    Document type Journal Article
    ZDB-ID 2390120-2
    ISSN 1876-4479 ; 1873-9946
    ISSN (online) 1876-4479
    ISSN 1873-9946
    DOI 10.1093/ecco-jcc/jjae031
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    Zs.A 6634: Show issues Location:
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  5. Article ; Online: Risk of Venous Thromboembolism With Tofacitinib Versus Tumor Necrosis Factor Inhibitors in Cardiovascular Risk-Enriched Rheumatoid Arthritis Patients.

    Charles-Schoeman, Christina / Fleischmann, Roy / Mysler, Eduardo / Greenwald, Maria / Ytterberg, Steven R / Koch, Gary G / Bhatt, Deepak L / Wang, Cunshan / Mikuls, Ted R / Chen, All-Shine / Connell, Carol A / Woolcott, John C / Menon, Sujatha / Chen, Yan / Lee, Kristen / Szekanecz, Zoltán

    Arthritis & rheumatology (Hoboken, N.J.)

    2024  

    Abstract: Objective: The ORAL Surveillance trial found a dose-dependent increase in venous thromboembolism (VTE) and pulmonary embolism (PE) events with tofacitinib versus tumor necrosis factor inhibitors (TNFi). We aimed to assess VTE incidence over time and ... ...

    Abstract Objective: The ORAL Surveillance trial found a dose-dependent increase in venous thromboembolism (VTE) and pulmonary embolism (PE) events with tofacitinib versus tumor necrosis factor inhibitors (TNFi). We aimed to assess VTE incidence over time and explore risk factors of VTE, including disease activity, in ORAL Surveillance.
    Methods: Patients with rheumatoid arthritis (RA) aged 50 years or older with at least one additional cardiovascular risk factor received tofacitinib 5 or 10 mg twice daily (BID) or TNFi. Post hoc, cumulative probabilities and incidence rates (patients with first events/100 patient-years) by 6-month intervals were estimated for adjudicated VTE, deep vein thrombosis, and PE. Cox regression models identified risk factors. Clinical Disease Activity Index leading up to the event was explored in patients with VTE.
    Results: Cumulative probabilities for VTE and PE were higher with tofacitinib 10 mg BID, but not 5 mg BID, versus TNFi. Incidence rates were consistent across 6-month intervals within treatments. Across treatments, risk factors for VTE included prior VTE, body mass index greater than or equal to 35 kg/m
    Conclusion: Incidences of VTE and PE were higher with tofacitinib (10 > 5 mg BID) versus TNFi and were generally consistent over time. Across treatments, VTE risk factors were aligned with previous studies in the general RA population. These data highlight the importance of assessing VTE risk factors, including age, body mass index, and VTE history, when considering initiation of tofacitinib or TNFi in patients with active RA.
    Language English
    Publishing date 2024-03-13
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2756371-6
    ISSN 2326-5205 ; 2326-5191
    ISSN (online) 2326-5205
    ISSN 2326-5191
    DOI 10.1002/art.42846
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    Zs.A 24: Show issues Location:
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  6. Article: Presence of risk factors associated with colectomy among patients with ulcerative colitis: a

    Rubin, David T / Salese, Leonardo / Cohen, Mitchell / Kotze, Paulo G / Woolcott, John C / Su, Chinyu / Mundayat, Rajiv / Paulissen, Jerome / Torres, Joana / Long, Millie D

    Therapeutic advances in gastroenterology

    2023  Volume 16, Page(s) 17562848231189122

    Abstract: Background: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC).: Objective: To assess colectomy incidence rates (IRs) and baseline characteristics for the presence of identified colectomy risk ... ...

    Abstract Background: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC).
    Objective: To assess colectomy incidence rates (IRs) and baseline characteristics for the presence of identified colectomy risk factors among patients in the tofacitinib OCTAVE UC clinical program.
    Design: This
    Methods: IRs [95% confidence interval (CI)] for colectomy were analyzed. Baseline risk factors based on clinical guidelines: aged <40 years at diagnosis, extensive colitis, severe endoscopic disease [Mayo endoscopic subscore (MES) = 3], hospitalization for UC within 12 months, C-reactive protein (CRP) >3 mg/L, and serum albumin <3.5 g/dL. Baseline risk factors were evaluated in patients who underwent colectomy by study and summarized descriptively.
    Results: Over a maximum of 7.8 years of tofacitinib exposure, 14 patients underwent colectomy: 3/1139 (0.3%) in OCTAVE Induction 1 and 2 [tofacitinib 10 mg twice daily (BID):
    Conclusions: Among patients with moderate to severe UC receiving tofacitinib, colectomies were infrequent; all patients undergoing colectomy had prior TNFi failure, and most had multiple additional risk factors. This provides important information to discuss with patients and inform management decisions.
    Registration: NCT01465763; NCT01458951; NCT01458574; and NCT01470612.
    Language English
    Publishing date 2023-08-07
    Publishing country England
    Document type Journal Article
    ZDB-ID 2440710-0
    ISSN 1756-2848 ; 1756-283X
    ISSN (online) 1756-2848
    ISSN 1756-283X
    DOI 10.1177/17562848231189122
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  7. Article ; Online: Improvements in Disease Activity Partially Mediate the Effect of Tofacitinib Treatment on Generic and Disease-Specific Health-Related Quality of Life in Patients with Ulcerative Colitis: Data from the OCTAVE Program.

    Dubinsky, Marla C / Armuzzi, Alessandro / Gecse, Krisztina B / Ullman, Thomas / Bushmakin, Andrew G / DiBonaventura, Marco / Cappelleri, Joseph C / Connelly, Susan B / Woolcott, John C / Salese, Leonardo

    Digestive diseases (Basel, Switzerland)

    2023  Volume 41, Issue 4, Page(s) 604–614

    Abstract: Background: Patients with ulcerative colitis (UC) often report impaired health-related quality of life (HRQoL). Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of UC. In addition to previous demonstrations of improved ... ...

    Abstract Background: Patients with ulcerative colitis (UC) often report impaired health-related quality of life (HRQoL). Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of UC. In addition to previous demonstrations of improved clinical measures (e.g., Mayo score), tofacitinib has been shown to improve HRQoL in patients with UC. This analysis explored the interrelationships among tofacitinib treatment, HRQoL, and disease activity (measured using Mayo subscores) using mediation modeling.
    Methods: Data were collected from two 8-week induction studies (OCTAVE Induction 1 and 2) in patients with moderate to severe UC treated with tofacitinib or placebo. Two mediation models were specified. First, Mayo subscores were mediators between the binary treatment variable (tofacitinib vs. placebo) and the eight Short Form-36 Health Survey (SF-36) domain scores as outcomes. Second, the four Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores served as outcomes. Both models used data collected at week 8.
    Results: Overall, 1,073 and 1,079 patients were included in the SF-36- and IBDQ-based models, respectively. For all SF-36 domains, improvements in Mayo subscores were estimated to explain 65.6% (bodily pain) to 92.9% (mental health) of the total treatment effect on SF-36 domain scores (all p < 0.05). For all IBDQ domains, improvements in Mayo subscores explained 71.6% (systemic symptoms) to 84.7% (emotional function) of the total treatment effect (all p < 0.05).
    Conclusion: Mayo scores and Mayo subscores are significant but incomplete contributors to tofacitinib's effect on HRQoL in patients with moderate to severe UC.
    Clinicaltrials: gov: NCT01465763; NCT01458951.
    MeSH term(s) Humans ; Colitis, Ulcerative/drug therapy ; Colitis, Ulcerative/diagnosis ; Piperidines/therapeutic use ; Piperidines/adverse effects ; Pyrimidines/therapeutic use ; Pyrimidines/adverse effects ; Quality of Life ; Treatment Outcome
    Chemical Substances Piperidines ; Pyrimidines ; tofacitinib (87LA6FU830)
    Language English
    Publishing date 2023-01-05
    Publishing country Switzerland
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 632798-9
    ISSN 1421-9875 ; 0257-2753
    ISSN (online) 1421-9875
    ISSN 0257-2753
    DOI 10.1159/000528788
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    Zs.A 1853: Show issues Location:
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  8. Article ; Online: Identification of Distinct Disease Activity Trajectories in Methotrexate-Naive Patients With Rheumatoid Arthritis Receiving Tofacitinib Over Twenty-Four Months.

    Bykerk, Vivian P / Lee, Eun Bong / van Vollenhoven, Ronald / Gruben, David C / Fallon, Lara / Woolcott, John C / Keystone, Edward

    Arthritis care & research

    2021  Volume 74, Issue 1, Page(s) 131–141

    Abstract: Objective: Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). To better understand tofacitinib treatment responses, we used group-based trajectory modeling to investigate distinct disease activity trajectories and ... ...

    Abstract Objective: Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). To better understand tofacitinib treatment responses, we used group-based trajectory modeling to investigate distinct disease activity trajectories and associated baseline variables in patients with active RA.
    Methods: This post hoc analysis used data from a phase III study of methotrexate-naive patients receiving tofacitinib 5 mg twice daily. Changes in the 4-variable Disease Activity Score in 28 joints, using the erythrocyte sedimentation rate (DAS28-ESR) from baseline to month 24 were used in group-based trajectory modeling to identify distinct disease activity trajectories. Patient and disease characteristics, changes in radiographic progression and patient-reported outcomes, and safety up to month 24 were compared among trajectory groups.
    Results: From 346 methotrexate-naive patients, 5 disease trajectory groups, defined by DAS28-ESR scores, were identified, which progressed from high disease activity (HDA) to remission (group 1, n = 28), to low disease activity (LDA) rapidly (group 2, n = 107), to moderate disease activity (group 3, n = 98), to LDA gradually (group 4, n = 46), or remained in HDA (group 5, n = 67), at month 24. At baseline, groups 1 and 2 generally had lower disease activity and more favorable patient-reported outcomes, compared with other groups. Improvements in radiographic progression and patient-reported outcomes over 24 months were generally consistent with DAS28-ESR-predicted disease activity trajectories. Adverse event rates were generally comparable across groups.
    Conclusion: Distinct phenotypic subgroups identified heterogeneity in patients with RA normally analyzed as a single population. Trajectory modeling may enable separation of clinically meaningful subsets of patients with RA, and may help optimize treatment outcomes.
    MeSH term(s) Adult ; Aged ; Arthritis, Rheumatoid/drug therapy ; Disease Progression ; Female ; Humans ; Janus Kinase Inhibitors/therapeutic use ; Male ; Middle Aged ; Models, Statistical ; Piperidines/therapeutic use ; Pyrimidines/therapeutic use ; Treatment Outcome
    Chemical Substances Janus Kinase Inhibitors ; Piperidines ; Pyrimidines ; tofacitinib (87LA6FU830)
    Language English
    Publishing date 2021-05-31
    Publishing country United States
    Document type Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 645059-3
    ISSN 2151-4658 ; 0893-7524 ; 2151-464X
    ISSN (online) 2151-4658
    ISSN 0893-7524 ; 2151-464X
    DOI 10.1002/acr.24709
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  9. Article ; Online: Predictors of Sustained Response With Tofacitinib Therapy in Patients With Ulcerative Colitis.

    Sandborn, William J / Armuzzi, Alessandro / Liguori, Giuseppina / Irving, Peter M / Sharara, Ala I / Mundayat, Rajiv / Lawendy, Nervin / Woolcott, John C / Danese, Silvio

    Inflammatory bowel diseases

    2021  Volume 28, Issue 9, Page(s) 1338–1347

    Abstract: Background: Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis. We evaluate baseline characteristics as predictors of sustained response and remission in patients with ulcerative colitis receiving tofacitinib ... ...

    Abstract Background: Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis. We evaluate baseline characteristics as predictors of sustained response and remission in patients with ulcerative colitis receiving tofacitinib maintenance therapy.
    Methods: Patients with clinical response following OCTAVE Induction 1 and 2 entered OCTAVE Sustain and were rerandomized to receive tofacitinib 5 or 10 mg twice daily or placebo. Baseline characteristics were stratified by week 52 efficacy endpoints (remission, sustained remission, clinical response, sustained clinical response). Associations between baseline characteristics and efficacy endpoints were evaluated using logistic regression analyses.
    Results: Overall, 170 of 487 (34.9%) patients were in remission at week 52. In multivariable modeling, endoscopic subscore at baseline of OCTAVE Induction 1 and 2 (2 vs 3; odds ratio [OR], 1.60; 95% confidence interval [CI], 1.06-2.44]), partial Mayo score (<2 vs ≥2; OR, 1.92; 95% CI, 1.27-2.90), and age (per 10-years; OR, 1.19; 95% CI, 1.02-1.39) at baseline of OCTAVE Sustain (following 8 weeks' tofacitinib induction therapy) were associated with higher odds of remission at week 52. Oral corticosteroid use (OR, 0.63; 95% CI, 0.42-0.96) and C-reactive protein (per unit; OR, 0.94; 95% CI, 0.89-0.99) at baseline of OCTAVE Sustain were associated with reduced likelihood of remission at week 52. In general, opposite associations were observed for time to loss of response.
    Conclusion: Patients with greater clinical improvement after 8 weeks of tofacitinib induction therapy are more likely to maintain response or remission with tofacitinib regardless of dose received during maintenance, highlighting the importance of a robust response to induction therapy.
    MeSH term(s) Child ; Colitis, Ulcerative/chemically induced ; Colitis, Ulcerative/drug therapy ; Humans ; Piperidines/adverse effects ; Pyrimidines/adverse effects ; Pyrroles/adverse effects ; Remission Induction
    Chemical Substances Piperidines ; Pyrimidines ; Pyrroles ; tofacitinib (87LA6FU830)
    Language English
    Publishing date 2021-12-03
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1340971-2
    ISSN 1536-4844 ; 1078-0998
    ISSN (online) 1536-4844
    ISSN 1078-0998
    DOI 10.1093/ibd/izab278
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  10. Article ; Online: Effectiveness and Safety of Tofacitinib in Canadian Patients With Rheumatoid Arthritis: Primary Results From a Prospective Observational Study.

    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

    Arthritis care & research

    2022  Volume 75, Issue 2, Page(s) 240–251

    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 ... ...

    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.
    MeSH term(s) Humans ; Prospective Studies ; Treatment Outcome ; Pyrroles/adverse effects ; Canada ; Arthritis, Rheumatoid/diagnosis ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/epidemiology ; Antirheumatic Agents/adverse effects
    Chemical Substances tofacitinib (87LA6FU830) ; Pyrroles ; Antirheumatic Agents
    Language English
    Publishing date 2022-10-10
    Publishing country United States
    Document type Observational Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 645059-3
    ISSN 2151-4658 ; 0893-7524 ; 2151-464X
    ISSN (online) 2151-4658
    ISSN 0893-7524 ; 2151-464X
    DOI 10.1002/acr.24966
    Database MEDical Literature Analysis and Retrieval System OnLINE

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