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  1. Article ; Online: Weighing the Risks and Benefits of Pneumocystis Jirovecii Pneumonia Prophylaxis in Rituximab Users.

    Wallace, Zachary S / Putman, Michael

    Arthritis & rheumatology (Hoboken, N.J.)

    2023  Volume 75, Issue 11, Page(s) 1904–1906

    MeSH term(s) Humans ; Pneumonia, Pneumocystis/prevention & control ; Pneumonia, Pneumocystis/drug therapy ; Rituximab/therapeutic use ; Cyclophosphamide/therapeutic use ; Risk Assessment
    Chemical Substances Rituximab (4F4X42SYQ6) ; Cyclophosphamide (8N3DW7272P)
    Language English
    Publishing date 2023-08-22
    Publishing country United States
    Document type Editorial ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural ; Comment
    ZDB-ID 2756371-6
    ISSN 2326-5205 ; 2326-5191
    ISSN (online) 2326-5205
    ISSN 2326-5191
    DOI 10.1002/art.42562
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  2. Article ; Online: Benchmarking tocilizumab use for giant cell arteritis.

    Conway, Richard / Putman, Michael S / Mackie, Sarah L

    Rheumatology advances in practice

    2022  Volume 6, Issue 2, Page(s) rkac037

    Language English
    Publishing date 2022-05-09
    Publishing country England
    Document type Editorial ; Comment
    ISSN 2514-1775
    ISSN (online) 2514-1775
    DOI 10.1093/rap/rkac037
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  3. Article: Fragility of randomised controlled trials for systemic lupus erythematosus and lupus nephritis therapies.

    Figueroa-Parra, Gabriel / Putman, Michael S / Crowson, Cynthia S / Duarte-García, Alí

    Lupus science & medicine

    2024  Volume 11, Issue 1

    Abstract: Objective: We aimed to evaluate the robustness of phase III randomised controlled trials (RCTs) for SLE and lupus nephritis (LN) using the fragility index (FI), the reverse FI (RFI) and the fragility quotient (FQ).: Methods: We searched for phase III ...

    Abstract Objective: We aimed to evaluate the robustness of phase III randomised controlled trials (RCTs) for SLE and lupus nephritis (LN) using the fragility index (FI), the reverse FI (RFI) and the fragility quotient (FQ).
    Methods: We searched for phase III RCTs that included patients with active SLE or LN. Data on primary endpoints, total participants and the number of events for each arm were obtained. We calculated the FI score for RCTs with statistically significant results (number of patients required to change from event to non-event to make the study lose statistical significance), the RFI for RCTs without statistically significant results (number of patients required to change from non-event to event to make study gain statistical significance) and the FQ score for both (FI or RFI score divided by the sample size).
    Results: We evaluated 20 RCTs (16 SLE, four LN). The mean FI/RFI score was 13.6 (SD 6.6). There were nine RCTs with statistically significant results (seven SLE, two LN), and the mean FI score was 10.2 (SD 6.2). The lowest FI was for the ILLUMINATE-2 trial (FI=2), and the highest FI was for the BLISS-52 trial (FI=17).Twelve studies had non-statistically significant results (10 SLE, two LN) with a mean RFI score of 15.6 (SD 6.1). The lowest RFI was for the ILLUMINATE-1 trial (RFI=4), and the highest RFI was for the TULIP-1 trial (RFI=27). The lowest FQ scores were found in the ILLUMINATE trials and the highest in the Rituximab trials (EXPLORER and LUNAR), meaning that the last ones were the most robust results after accounting for sample size.
    Conclusions: The evidence of therapies for patients with SLE and LN is derived mostly from fragile RCTs. Clinicians and trialists must be aware of the fragility of these RCTs for clinical decision-making and designing trials for novel therapeutics.
    MeSH term(s) Humans ; Clinical Decision-Making ; Lupus Erythematosus, Systemic/complications ; Lupus Erythematosus, Systemic/drug therapy ; Lupus Nephritis/drug therapy ; Randomized Controlled Trials as Topic ; Rituximab/therapeutic use
    Chemical Substances Rituximab (4F4X42SYQ6)
    Language English
    Publishing date 2024-01-10
    Publishing country England
    Document type Journal Article
    ZDB-ID 2779620-6
    ISSN 2053-8790
    ISSN 2053-8790
    DOI 10.1136/lupus-2023-001068
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  4. Article: Learning from Adversity: Lessons from the COVID-19 Crisis.

    Putman, Michael S / Ruderman, Eric M

    The Journal of rheumatology

    2020  Volume 47, Issue 6, Page(s) 791–792

    MeSH term(s) Betacoronavirus ; COVID-19 ; Communicable Disease Control/organization & administration ; Coronavirus Infections/diagnosis ; Coronavirus Infections/epidemiology ; Female ; Health Care Costs ; Humans ; Insurance Coverage/statistics & numerical data ; Male ; Pandemics/prevention & control ; Pandemics/statistics & numerical data ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/epidemiology ; Program Development ; Program Evaluation ; Risk Assessment ; SARS-CoV-2 ; Telemedicine/organization & administration ; United States
    Keywords covid19
    Language English
    Publishing date 2020-04-08
    Publishing country Canada
    Document type Editorial ; Review
    ZDB-ID 194928-7
    ISSN 1499-2752 ; 0315-162X
    ISSN (online) 1499-2752
    ISSN 0315-162X
    DOI 10.3899/jrheum.200411
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    Zs.MO 135: Show issues

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  5. Article ; Online: Differentiating biologics to prevent psoriatic arthritis in patients with psoriasis - Authors' reply.

    Singla, Shikha / Putman, Michael / Liew, Jean / Gordon, Kenneth

    The Lancet. Rheumatology

    2023  Volume 5, Issue 6, Page(s) e313

    MeSH term(s) Humans ; Arthritis, Psoriatic/complications ; Biological Products/therapeutic use ; Psoriasis/complications ; Patients
    Chemical Substances Biological Products
    Language English
    Publishing date 2023-04-21
    Publishing country England
    Document type Letter
    ISSN 2665-9913
    ISSN (online) 2665-9913
    DOI 10.1016/S2665-9913(23)00124-8
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  6. Article ; Online: Association between biological immunotherapy for psoriasis and time to incident inflammatory arthritis: a retrospective cohort study.

    Singla, Shikha / Putman, Michael / Liew, Jean / Gordon, Kenneth

    The Lancet. Rheumatology

    2023  Volume 5, Issue 4, Page(s) e200–e207

    Abstract: Background: Targeted biological immunotherapies have been highly effective in controlling skin disease in patients with psoriasis, but whether therapy delays progression to inflammatory arthritis is unclear. The aim of this study was to compare the time ...

    Abstract Background: Targeted biological immunotherapies have been highly effective in controlling skin disease in patients with psoriasis, but whether therapy delays progression to inflammatory arthritis is unclear. The aim of this study was to compare the time to incident inflammatory arthritis among patients newly receiving biological therapies for psoriasis.
    Methods: In this retrospective cohort study, we obtained data on a national sample of patients in the USA from the electronic health records database of the US-based TriNetX network. We included adult patients (aged ≥18 years) with two diagnostic codes for psoriasis (>30 days apart; International Classification of Diseases [ICD] codes) who had been newly prescribed a biologic (inhibitors of tumour necrosis factor [TNF], interleukin [IL]-17, IL-23, or IL-12/23, first prescribed on or after the date of receiving a first psoriasis diagnosis code). The time to incident inflammatory arthritis, defined by first occurrence of a diagnostic code for psoriatic arthritis or other inflammatory arthritis after initiation of biological therapy, was graphed with use of the Kaplan-Meier estimate. Time-dependent risk for inflammatory arthritis was calculated with weighted Cox proportional hazards regression with anti-TNF exposure as the reference, adjusted for demographic and clinical covariables. Sensitivity analyses were used to evaluate incident cases of psoriasis, increased exclusion periods for prevalent cases of inflammatory arthritis, drug switching, and more stringent disease and outcome definitions.
    Findings: Between Jan 1, 2014, and June 1, 2022, we identified 15 501 patients with psoriasis (mean age 50·2 years [SD 15·0]; 8399 [54·2%] women and 7102 [45·8%] men; 11 175 [72·1%] White). 976 (6·3%) of the 15 501 patients developed inflammatory arthritis, with a cumulative incidence of 2·6 cases per 100 person-years. In multivariable regression analyses, the risk of developing inflammatory arthritis was significantly lower in patients prescribed IL-12/23 inhibitors (adjusted HR 0·58, 95% CI 0·43-0·76) or IL-23 inhibitors (0·41, 0·17-0·95) than in patients prescribed TNF inhibitors. We found no significant difference for IL-17 inhibitors (0·86, 0·54-1·38) compared with TNF inhibitors. For IL-12/23 inhibitors, the results persisted in all sensitivity analyses. For IL-23 inhibitors, the results persisted in three of six sensitivity analyses, when a higher diagnostic threshold for incident arthritis was used and when excluding patients who developed arthritis within 3 or 6 months after first biologic prescription.
    Interpretation: In this large cohort study of patients with psoriasis, treatment with IL-12/23 inhibitors or IL-23 inhibitors was associated with reduced risk of progression to inflammatory arthritis compared with TNF inhibitors. Prospective observational cohorts with disease activity measures and pooled analyses of previous randomised trials are required to confirm these findings.
    Funding: None.
    MeSH term(s) Adolescent ; Adult ; Female ; Humans ; Male ; Middle Aged ; Arthritis, Psoriatic/drug therapy ; Biological Products ; Cohort Studies ; Immunotherapy/adverse effects ; Interleukin Inhibitors ; Interleukin-12 ; Interleukin-23 ; Psoriasis/drug therapy ; Retrospective Studies ; Tumor Necrosis Factor Inhibitors
    Chemical Substances Biological Products ; Interleukin Inhibitors ; Interleukin-12 (187348-17-0) ; Interleukin-23 ; Tumor Necrosis Factor Inhibitors
    Language English
    Publishing date 2023-03-06
    Publishing country England
    Document type Journal Article
    ISSN 2665-9913
    ISSN (online) 2665-9913
    DOI 10.1016/S2665-9913(23)00034-6
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  7. Article ; Online: Giant Cell Arteritis and Polymyalgia Rheumatica: Treatment Approaches and New Targets.

    Nepal, Desh / Putman, Michael / Unizony, Sebastian

    Rheumatic diseases clinics of North America

    2023  Volume 49, Issue 3, Page(s) 505–521

    Abstract: Prolonged glucocorticoid tapers have been the standard of care for giant cell arteritis (GCA) and polymyalgia rheumatica (PMR), but recent advancements have improved outcomes for patients with GCA while reducing glucocorticoid-related toxicities. Many ... ...

    Abstract Prolonged glucocorticoid tapers have been the standard of care for giant cell arteritis (GCA) and polymyalgia rheumatica (PMR), but recent advancements have improved outcomes for patients with GCA while reducing glucocorticoid-related toxicities. Many patients with GCA and PMR still experience persistent or relapsing disease, and cumulative exposure to glucocorticoids for both diseases remains high. The objective of this review is to define current treatment approaches as well as new therapeutic targets and strategies. Studies investigating inhibition of cytokine pathways, including interleukin-6, interleukin-17, interleukin-23, granulocyte-macrophage colony-stimulating factor, Janus kinase-signal transduction and activator of transcription, and others, will be reviewed.
    MeSH term(s) Humans ; Polymyalgia Rheumatica/drug therapy ; Giant Cell Arteritis/drug therapy ; Glucocorticoids/therapeutic use
    Chemical Substances Glucocorticoids
    Language English
    Publishing date 2023-04-18
    Publishing country United States
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 92118-x
    ISSN 1558-3163 ; 0889-857X
    ISSN (online) 1558-3163
    ISSN 0889-857X
    DOI 10.1016/j.rdc.2023.03.005
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    Se 363: Show issues Location:
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  8. Article ; Online: Advocating for better trials in rheumatology.

    Kaushik, Sharanya / Junek, Mats / Putman, Michael

    Rheumatology (Oxford, England)

    2023  Volume 62, Issue 12, Page(s) 3776–3777

    MeSH term(s) Humans ; Rheumatology ; Rheumatic Diseases/drug therapy
    Language English
    Publishing date 2023-09-13
    Publishing country England
    Document type Journal Article
    ZDB-ID 1464822-2
    ISSN 1462-0332 ; 1462-0324
    ISSN (online) 1462-0332
    ISSN 1462-0324
    DOI 10.1093/rheumatology/kead459
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  9. Article ; Online: Risk of neuroinflammatory diseases among new users of biologic and targeted synthetic disease-modifying antirheumatic drugs.

    Casey, Maximilian / Pannu, Sonia / Bajwa, Saffia / Duarte-García, Alí / Putman, Michael

    Arthritis care & research

    2024  

    Abstract: Background: Neuroinflammatory adverse events have been observed among new users of tumor necrosis factor (TNF) inhibitors. No studies to date have compared the real-world risk of TNFs to other new users of biologic or targeted synthetic disease ... ...

    Abstract Background: Neuroinflammatory adverse events have been observed among new users of tumor necrosis factor (TNF) inhibitors. No studies to date have compared the real-world risk of TNFs to other new users of biologic or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARD). The objective of this study is to describe the risk of neuroinflammatory disease after initiation b/tsDMARDs.
    Methods: This new-user comparative effectiveness cohort study utilized a large US-based electronic health-records database to describe the unadjusted incidence of neuroinflammatory adverse events over a 3-year period. The cohort included patients with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis initiating treatment with a TNFi (n=93,661) or other b/tsDMARD (n=38,354) were included.
    Results: Among 132,015 patients included in the analysis, the most common first biologic agent was a TNF inhibitor, the unadjusted incidence of neuroinflammatory events was numerically lower among new users of TNF inhibitors (incidence 1.34 per 1,000 patient-years) as compared to the combined non-TNF group (1.69 per 1,000 patient-years). There was no significant association between TNF exposure and neuroinflammatory events as compared to the combined non-TNF b/tsDMARDs overall (hazard ratio [HR] 1.01, 95% confidence interval [CI] 0.75-1.36) and within each disease group.
    Conclusion: The overall risk of neuroinflammatory events among new users of TNF inhibitors did not differ substantially as compared to new users of other b/tsDMARDs. Meta-analyses of randomized trials should be conducted to corroborate these findings, which may be affected by channeling bias.
    Language English
    Publishing date 2024-04-03
    Publishing country United States
    Document type Journal Article
    ZDB-ID 645059-3
    ISSN 2151-4658 ; 0893-7524 ; 2151-464X
    ISSN (online) 2151-4658
    ISSN 0893-7524 ; 2151-464X
    DOI 10.1002/acr.25340
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