Systemic Lupus Erythematosus

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Michelle Petri - One of the best experts on this subject based on the ideXlab platform.

  • the frequency of Lupus anticoagulant in Systemic Lupus Erythematosus
    Annals of Internal Medicine, 2020
    Co-Authors: Michelle Petri, Margaret Rheinschmidt, Quinn Whitingokeefe, David B Hellmann, Laurence Corash
    Abstract:

    Abstract Recent reviews have suggested a higher frequency of the Lupus anticoagulant or related antiphospholipid antibodies in patients with Systemic Lupus Erythematosus (21% to 65%) than was found...

  • Baricitinib for Systemic Lupus Erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial
    The Lancet, 2018
    Co-Authors: Daniel J. Wallace, Yoshiya Tanaka, Richard Furie, Kenneth C. Kalunian, Marta Mosca, Michelle Petri, Thomas Dörner, Mario H. Cardiel, Ian N. Bruce, Elisa Gomez
    Abstract:

    Summary Background Patients with Systemic Lupus Erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with Systemic Lupus Erythematosus. Methods In this double-blind, multicentre, randomised, placebo-controlled, 24-week phase 2 study, patients were recruited from 78 centres in 11 countries. Eligible patients were aged 18 years or older, had a diagnosis of Systemic Lupus Erythematosus, and had active disease involving skin or joints. We randomly assigned patients (1:1:1) to receive once-daily baricitinib 2 mg, baricitinib 4 mg, or placebo for 24 weeks. The primary endpoint was the proportion of patients achieving resolution of arthritis or rash at week 24, as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov , number NCT02708095 . Findings Between March 24, 2016, and April 27, 2017, 314 patients were randomly assigned to receive placebo (n=105), baricitinib 2 mg (n=105), or baricitinib 4 mg (n=104). At week 24, resolution of SLEDAI-2K arthritis or rash was achieved by 70 (67%) of 104 patients receiving baricitinib 4 mg (odds ratio [OR] vs placebo 1·8, 95% CI 1·0–3·3; p=0·0414) and 61 (58%) of 105 patients receiving baricitinib 2 mg (OR 1·3, 0·7–2·3; p=0·39). Adverse events were reported in 68 (65%) patients in the placebo group, 75 (71%) patients in the baricitinib 2 mg group, and 76 (73%) patients in the baricitinib 4 mg group. Serious adverse events were reported in ten (10%) patients receiving baricitinib 4 mg, 11 (10%) receiving baricitinib 2 mg, and five (5%) receiving placebo; no deaths were reported. Serious infections were reported in six (6%) patients with baricitinib 4 mg, two (2%) with baricitinib 2 mg, and one (1%) with placebo. Interpretation The baricitinib 4 mg dose, but not the 2 mg dose, significantly improved the signs and symptoms of active Systemic Lupus Erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the foundation for future phase 3 trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for Systemic Lupus Erythematosus. Funding Eli Lilly and Company.

  • novel evidence based Systemic Lupus Erythematosus responder index
    Arthritis & Rheumatism, 2009
    Co-Authors: Richard Furie, A Weinstein, Daniel J. Wallace, Joan T. Merrill, Michelle Petri, Ellen M Ginzler, William Stohl, Winn W Chatham, Vibeke Strand, Marc Chevrier
    Abstract:

    Objective To describe a new Systemic Lupus Erythematosus (SLE) Responder Index (SRI) based on the belimumab phase II SLE trial and demonstrate its potential utility in SLE clinical trials.

  • combined oral contraceptives in women with Systemic Lupus Erythematosus
    The New England Journal of Medicine, 2005
    Co-Authors: Michelle Petri, Joan T. Merrill, Kenneth C. Kalunian, Lisa R Sammaritano, Michael D Lockshin, Mimi Y Kim, Jennifer M Grossman, Bevra H Hahn, Michael H Belmont, Anca Askanase
    Abstract:

    background Oral contraceptives are rarely prescribed for women with Systemic Lupus Erythematosus, because of concern about potential negative side effects. In this double-blind, randomized, noninferiority trial, we prospectively evaluated the effect of oral contraceptives on Lupus activity in premenopausal women with Systemic Lupus Erythematosus. methods A total of 183 women with inactive (76 percent) or stable active (24 percent) Systemic Lupus Erythematosus at 15 U.S. sites were randomly assigned to receive either oral contraceptives (triphasic ethinyl estradiol at a dose of 35 µg plus norethindrone at a dose of 0.5 to 1 mg for 12 cycles of 28 days each; 91 women) or placebo (92 women) and were evaluated at months 1, 2, 3, 6, 9, and 12. Subjects were excluded if they had moderate or high levels of anticardiolipin antibodies, Lupus anticoagulant, or a history of thrombosis. results The primary end point, a severe Lupus flare, occurred in 7 of 91 subjects receiving oral contraceptives (7.7 percent) as compared with 7 of 92 subjects receiving placebo (7.6 percent). The 12-month rates of severe flare were similar: 0.084 for the group receiving oral contraceptives and 0.087 for the placebo group (P=0.95; upper limit of the one-sided 95 percent confidence interval for this difference, 0.069, which is within the prespecified 9 percent margin for noninferiority). Rates of mild or moderate flares were 1.40 flares per person-year for subjects receiving oral contraceptives and 1.44 flares per person-year for subjects receiving placebo (relative risk, 0.98; P=0.86). In the group that was randomized to receive oral contraceptives, there was one deep venous thrombosis and one clotted graft; in the placebo group, there was one deep venous thrombosis, one ocular thrombosis, one superficial thrombophlebitis, and one death (after cessation of the trial). conclusions Our study indicates that oral contraceptives do not increase the risk of flare among women with Systemic Lupus Erythematosus whose disease is stable.

Daniel J. Wallace - One of the best experts on this subject based on the ideXlab platform.

  • psychometric validation of the arthritis helplessness index in Systemic Lupus Erythematosus
    Lupus, 2018
    Co-Authors: Shadi Gholizadeh, Daniel J. Wallace, Desiree R Azizoddin, Steven Mills, G Zamoraracaza, H M K Potemra, Michael H Weisman, Perry M Nicassio
    Abstract:

    ObjectiveHelplessness is a relevant construct in Systemic Lupus Erythematosus (SLE), an unpredictable chronic illness with no known cure characterized by relapsing and remitting features. However, ...

  • Baricitinib for Systemic Lupus Erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial
    The Lancet, 2018
    Co-Authors: Daniel J. Wallace, Yoshiya Tanaka, Richard Furie, Kenneth C. Kalunian, Marta Mosca, Michelle Petri, Thomas Dörner, Mario H. Cardiel, Ian N. Bruce, Elisa Gomez
    Abstract:

    Summary Background Patients with Systemic Lupus Erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with Systemic Lupus Erythematosus. Methods In this double-blind, multicentre, randomised, placebo-controlled, 24-week phase 2 study, patients were recruited from 78 centres in 11 countries. Eligible patients were aged 18 years or older, had a diagnosis of Systemic Lupus Erythematosus, and had active disease involving skin or joints. We randomly assigned patients (1:1:1) to receive once-daily baricitinib 2 mg, baricitinib 4 mg, or placebo for 24 weeks. The primary endpoint was the proportion of patients achieving resolution of arthritis or rash at week 24, as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov , number NCT02708095 . Findings Between March 24, 2016, and April 27, 2017, 314 patients were randomly assigned to receive placebo (n=105), baricitinib 2 mg (n=105), or baricitinib 4 mg (n=104). At week 24, resolution of SLEDAI-2K arthritis or rash was achieved by 70 (67%) of 104 patients receiving baricitinib 4 mg (odds ratio [OR] vs placebo 1·8, 95% CI 1·0–3·3; p=0·0414) and 61 (58%) of 105 patients receiving baricitinib 2 mg (OR 1·3, 0·7–2·3; p=0·39). Adverse events were reported in 68 (65%) patients in the placebo group, 75 (71%) patients in the baricitinib 2 mg group, and 76 (73%) patients in the baricitinib 4 mg group. Serious adverse events were reported in ten (10%) patients receiving baricitinib 4 mg, 11 (10%) receiving baricitinib 2 mg, and five (5%) receiving placebo; no deaths were reported. Serious infections were reported in six (6%) patients with baricitinib 4 mg, two (2%) with baricitinib 2 mg, and one (1%) with placebo. Interpretation The baricitinib 4 mg dose, but not the 2 mg dose, significantly improved the signs and symptoms of active Systemic Lupus Erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the foundation for future phase 3 trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for Systemic Lupus Erythematosus. Funding Eli Lilly and Company.

  • epratuzumab for Systemic Lupus Erythematosus
    Lupus, 2013
    Co-Authors: Daniel J. Wallace, D M Goldenberg
    Abstract:

    Epratuzumab (EMab, UCB, Immunomedics) is a humanized monoclonal antibody targeting CD22 that is being studied in clinical trials for patients with a variety of rheumatic and hematologic conditions, including Systemic Lupus Erythematosus (SLE). An overview of its mechanism of action is followed by a summary of completed Lupus studies, and a preview of studies in progress. The agent clearly has anti-inflammatory activity and is a potentially useful agent in the management of autoimmune disorders.

  • novel evidence based Systemic Lupus Erythematosus responder index
    Arthritis & Rheumatism, 2009
    Co-Authors: Richard Furie, A Weinstein, Daniel J. Wallace, Joan T. Merrill, Michelle Petri, Ellen M Ginzler, William Stohl, Winn W Chatham, Vibeke Strand, Marc Chevrier
    Abstract:

    Objective To describe a new Systemic Lupus Erythematosus (SLE) Responder Index (SRI) based on the belimumab phase II SLE trial and demonstrate its potential utility in SLE clinical trials.

Bruce Freundlich - One of the best experts on this subject based on the ideXlab platform.

Richard Furie - One of the best experts on this subject based on the ideXlab platform.

  • trial of anifrolumab in active Systemic Lupus Erythematosus
    The New England Journal of Medicine, 2020
    Co-Authors: Eric F. Morand, Yoshiya Tanaka, Philip Brohawn, Richard Furie, Ian N. Bruce, Lilia Pineda, Anca Askanase, C Richez, Sangcheol Bae, Anna Berglind
    Abstract:

    Abstract Background Anifrolumab, a human monoclonal antibody to type I interferon receptor subunit 1 investigated for the treatment of Systemic Lupus Erythematosus (SLE), did not have a significant...

  • Baricitinib for Systemic Lupus Erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial
    The Lancet, 2018
    Co-Authors: Daniel J. Wallace, Yoshiya Tanaka, Richard Furie, Kenneth C. Kalunian, Marta Mosca, Michelle Petri, Thomas Dörner, Mario H. Cardiel, Ian N. Bruce, Elisa Gomez
    Abstract:

    Summary Background Patients with Systemic Lupus Erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with Systemic Lupus Erythematosus. Methods In this double-blind, multicentre, randomised, placebo-controlled, 24-week phase 2 study, patients were recruited from 78 centres in 11 countries. Eligible patients were aged 18 years or older, had a diagnosis of Systemic Lupus Erythematosus, and had active disease involving skin or joints. We randomly assigned patients (1:1:1) to receive once-daily baricitinib 2 mg, baricitinib 4 mg, or placebo for 24 weeks. The primary endpoint was the proportion of patients achieving resolution of arthritis or rash at week 24, as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov , number NCT02708095 . Findings Between March 24, 2016, and April 27, 2017, 314 patients were randomly assigned to receive placebo (n=105), baricitinib 2 mg (n=105), or baricitinib 4 mg (n=104). At week 24, resolution of SLEDAI-2K arthritis or rash was achieved by 70 (67%) of 104 patients receiving baricitinib 4 mg (odds ratio [OR] vs placebo 1·8, 95% CI 1·0–3·3; p=0·0414) and 61 (58%) of 105 patients receiving baricitinib 2 mg (OR 1·3, 0·7–2·3; p=0·39). Adverse events were reported in 68 (65%) patients in the placebo group, 75 (71%) patients in the baricitinib 2 mg group, and 76 (73%) patients in the baricitinib 4 mg group. Serious adverse events were reported in ten (10%) patients receiving baricitinib 4 mg, 11 (10%) receiving baricitinib 2 mg, and five (5%) receiving placebo; no deaths were reported. Serious infections were reported in six (6%) patients with baricitinib 4 mg, two (2%) with baricitinib 2 mg, and one (1%) with placebo. Interpretation The baricitinib 4 mg dose, but not the 2 mg dose, significantly improved the signs and symptoms of active Systemic Lupus Erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the foundation for future phase 3 trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for Systemic Lupus Erythematosus. Funding Eli Lilly and Company.

  • novel evidence based Systemic Lupus Erythematosus responder index
    Arthritis & Rheumatism, 2009
    Co-Authors: Richard Furie, A Weinstein, Daniel J. Wallace, Joan T. Merrill, Michelle Petri, Ellen M Ginzler, William Stohl, Winn W Chatham, Vibeke Strand, Marc Chevrier
    Abstract:

    Objective To describe a new Systemic Lupus Erythematosus (SLE) Responder Index (SRI) based on the belimumab phase II SLE trial and demonstrate its potential utility in SLE clinical trials.

D Norden - One of the best experts on this subject based on the ideXlab platform.

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