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Reviews on Recent Clinical Trials 2017Since more than 50 years glucocorticoids represent the milestone in the treatment of inflammatory diseases, including rheumatoid arthritis (RA). However, many patients... (Review)
Review
BACKGROUND
Since more than 50 years glucocorticoids represent the milestone in the treatment of inflammatory diseases, including rheumatoid arthritis (RA). However, many patients with RA present a circadian rhythm in symptoms severity with a significant worsening in the morning, that correlates with cyclic changes in circulating hormones and cytokines. Classical steroid therapy given in the morning fails to intercept this pathophysiological phenomenon. In the last years, a novel formulation of prednisone has been developed in order to better fit these variations, improve efficacy and minimize adverse events (chronotherapy). This modified-release (MR) prednisone is administered in the evening at 10.00 p.m. and absorbed after about 4 hours.
METHODS
In this article, we reviewed the recent clinical trials evaluating the efficacy of MR prednisone in RA patients, including two randomized controlled double-blind clinical trials Circadian Administration of Prednisone in Rheumatoid Arthritis - 1 (CAPRA-1) and CAPRA-2 and other nonrandomized observational studies.
RESULTS
According to the available evidence, MR prednisone seems effective in ameliorating morning stiffness in RA patients.
CONCLUSION
In conclusion, the use of MR prednisone in the treatment regimen could be a costeffective choice in a significant proportion of RA patients, particularly in those with a clinical phenotype characterized by morning stiffness or morning recrudescence of pain. With regards to the safety, MR prednisone adverse events profile does not differ from that of IR glucocorticoids.
Topics: Anti-Inflammatory Agents; Arthritis, Rheumatoid; Delayed-Action Preparations; Drug Administration Schedule; Drug Chronotherapy; Female; Humans; Male; Pain Measurement; Prednisone; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome
PubMed: 28356031
DOI: 10.2174/1574887112666170328124539 -
Seminars in Arthritis and Rheumatism Jun 2019In recent years, low disease activity emerged as a state that is associated with improved long-term outcomes in systemic lupus erythematosus (SLE). Our aim was to review... (Review)
Review
BACKGROUND
In recent years, low disease activity emerged as a state that is associated with improved long-term outcomes in systemic lupus erythematosus (SLE). Our aim was to review the current concepts for low disease activity in SLE in order to serve as the basis of a future consensus for standardization.
METHODS
The PubMed database was searched for relevant articles from inception up to July 2018. Medical Subject Headings (MeSH terms) included "lupus" AND "low disease activity" OR "minimal disease activity".
RESULTS
Three different definitions of low disease activity in lupus have been proposed. Minimal disease activity (MDA) is defined as a clinical SLE Disease Activity Index 2000 (SLEDAI-2K)≤1 on antimalarials, immunosuppressives in standard doses and prednisone ≤5 mg/day. Low disease activity (LDA) allows for a clinical SLEDAI-2K≤2 maintained on antimalarials only. Lupus Low Disease Activity State (LLDAS) accepts a SLEDAI-2K≤4 with no activity from major organ systems, a Physician's Global Assessment of ≤1 with no new activity, prednisone dose ≤7.5 mg/day and standard doses of antimalarials, immunosuppressives and biologics. Active serology (anti-dsDNA and complement C3/C4) is not included in the MDA and LDA but counts towards disease activity in the LLDAS definition. All definitions were associated with less damage-accrual and mortality in the long-term that were comparable to those of clinical remission.
CONCLUSIONS
There is solid evidence that low disease activity is associated with improved outcomes in SLE and could serve as a therapeutic target in daily practice and clinical trials. Future research should focus on advancing a consensus for the best possible definition.
Topics: Disease Progression; Humans; Immunosuppressive Agents; Lupus Erythematosus, Systemic; Prednisone; Remission Induction; Severity of Illness Index
PubMed: 30415943
DOI: 10.1016/j.semarthrit.2018.10.013 -
International Heart Journal Mar 2022Atrial inflammation and fibrosis have long been considered culprits in the development of atrial fibrillation (AF). Prior clinical studies showed that corticosteroid...
Atrial inflammation and fibrosis have long been considered culprits in the development of atrial fibrillation (AF). Prior clinical studies showed that corticosteroid therapy is beneficial in patients with AF. Here we sought to determine whether prednisone treatment prevents atrial tachypacing (ATP) induced atrial fibrosis.Dogs were randomized into the sham, ATP, ATP + low-dose prednisone (ALP), and ATP + high-dose prednisone (AHP) groups. After 6 days of recovery from surgery, dogs were subjected to ATP at 400 beats per minute for 4 weeks while being treated with prednisone (15 or 40 mg/day) or a placebo. Pacemakers were not activated in the sham group.Compared with the ATP group, the expression of collagen I, collagen III, α-smooth muscle actin, transforming growth factor-β1 and connective tissue growth factor were significantly reduced in the ALP and AHP groups. Fluorescence assays showed that reactive oxygen species formation in the right atrium was suppressed in the ALP and AHP groups compared with the ATP group. The protein level of NADPH oxidase 2 was reduced in the ALP and AHP groups' versus ATP group, while NOX4 and NOX5 were unchanged. ATP-induced downregulation of BH4 and eNOS uncoupling in the atria was partially restored in the prednisone-treated groups.Our study demonstrated that atrial fibrosis induced by ATP were suppressed by prednisone. Low-dose prednisone was also effective in suppressing the development of atrial fibrosis.
Topics: Animals; Atrial Fibrillation; Dog Diseases; Dogs; Fibrosis; Heart Atria; Inflammation; Prednisone; Treatment Outcome
PubMed: 35296611
DOI: 10.1536/ihj.21-249 -
Jornal Brasileiro de Pneumologia :... Oct 2014To evaluate the effect size of oral corticosteroid treatment on eosinophilic bronchitis in asthma, through systematic review and meta-analysis. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To evaluate the effect size of oral corticosteroid treatment on eosinophilic bronchitis in asthma, through systematic review and meta-analysis.
METHODS
We systematically reviewed articles in the Medline, Cochrane Controlled Trials Register, EMBASE, and LILACS databases. We selected studies meeting the following criteria: comparing at least two groups or time points (prednisone vs. control, prednisone vs. another drug, or pre- vs. post-treatment with prednisone); and evaluating parameters before and after prednisone use, including values for sputum eosinophils, sputum eosinophil cationic protein (ECP), and sputum IL-5-with or without values for post-bronchodilator FEV1-with corresponding 95% CIs or with sufficient data for calculation. The independent variables were the use, dose, and duration of prednisone treatment. The outcomes evaluated were sputum eosinophils, IL-5, and ECP, as well as post-bronchodilator FEV1.
RESULTS
The pooled analysis of the pre- vs. post-treatment data revealed a significant mean reduction in sputum eosinophils (↓8.18%; 95% CI: 7.69-8.67; p < 0.001), sputum IL-5 (↓83.64 pg/mL; 95% CI: 52.45-114.83; p < 0.001), and sputum ECP (↓267.60 µg/L; 95% CI: 244.57-290.63; p < 0.0001), as well as a significant mean increase in post-bronchodilator FEV1 (↑8.09%; 95% CI: 5.35-10.83; p < 0.001).
CONCLUSIONS
In patients with moderate-to-severe eosinophilic bronchitis, treatment with prednisone caused a significant reduction in sputum eosinophil counts, as well as in the sputum levels of IL-5 and ECP. This reduction in the inflammatory response was accompanied by a significant increase in post-bronchodilator FEV1.
Topics: Anti-Inflammatory Agents; Asthma; Bronchitis; Eosinophilia; Eosinophils; Humans; Leukocyte Count; Prednisone; Sputum
PubMed: 25410844
DOI: 10.1590/s1806-37132014000500012 -
Clinical Lymphoma, Myeloma & Leukemia Nov 2021In the phase 3 ALCYONE study, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) versus bortezomib/melphalan/prednisone (VMP) significantly improved...
Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE.
BACKGROUND
In the phase 3 ALCYONE study, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) versus bortezomib/melphalan/prednisone (VMP) significantly improved progression-free survival (PFS) and overall survival (OS) in transplant-ineligible, newly diagnosed multiple myeloma (NDMM) patients. We present a subgroup analysis of ALCYONE by patient frailty status.
PATIENTS AND METHODS
Frailty assessment was performed retrospectively using age, Charlson comorbidity index, and baseline Eastern Cooperative Oncology Group performance status score. Patients were classified as fit (0), intermediate (1), or frail (≥2); a nonfrail category combined fit and intermediate patients.
RESULTS
Among randomized patients (D-VMP, n = 350; VMP, n = 356), 391 (55.4%) were nonfrail (D-VMP, 187 [53.4%]; VMP, 204 [57.3%]) and 315 (44.6%) were frail (163 [46.6%]; 152 [42.7%]). After 40.1-months median follow-up, nonfrail patients had longer PFS and OS than frail patients, but benefits of D-VMP versus VMP were maintained across subgroups: PFS nonfrail (median, 45.7 vs. 19.1 months; hazard ratio [HR], 0.36; P < .0001), frail (32.9 vs. 19.5 months; HR, 0.51; P < .0001); OS nonfrail (36-month rate, 83.6% vs. 74.5%), frail (71.4% vs. 59.0%). Improved greater than or equal to complete response and minimal residual disease (10)-negativity rates were observed for D-VMP versus VMP across subgroups. The 2 most common grade 3/4 treatment-emergent adverse events were neutropenia (nonfrail: 39.2% [D-VMP] and 42.4% [VMP]; frail: 41.3% and 34.4%) and thrombocytopenia (nonfrail: 32.8% and 36.9%; frail: 36.9% and 39.1%).
CONCLUSION
Our findings support the clinical benefit of D-VMP in transplant-ineligible NDMM patients enrolled in ALCYONE, regardless of frailty status.
Topics: Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Female; Humans; Male; Melphalan; Multiple Myeloma; Prednisone
PubMed: 34344638
DOI: 10.1016/j.clml.2021.06.005 -
Clinical Immunology (Orlando, Fla.) Jun 2023Alternatives are urgently needed in patients with CD3 CD4 lymphocytic-variant hypereosinophilic syndrome (L-HES) requiring high-level steroids or who are unresponsive...
Alternatives are urgently needed in patients with CD3 CD4 lymphocytic-variant hypereosinophilic syndrome (L-HES) requiring high-level steroids or who are unresponsive and/or intolerant to conventional alternative therapies. We report five L-HES patients (44-66 years) with cutaneous involvement (n = 5) and persistent eosinophilia (n = 3) despite conventional therapies, who successfully received JAK inhibitors (tofacitinib n = 1, ruxolitinib n = 4). JAKi led to complete clinical remission in the first 3 months in all (with prednisone withdrawal in four). Absolute eosinophil counts normalized in cases receiving ruxolitinib, while reduction was partial under tofacitinib. After switch from tofacitinib to ruxolitinib, complete clinical response persisted despite prednisone withdrawal. The clone size remained stable in all patients. After 3-13 months of follow-up, no adverse event was reported. Prospective clinical trials are warranted to examine the use of JAKi in L-HES.
Topics: Humans; Prednisone; Prospective Studies; CD3 Complex; Hypereosinophilic Syndrome; CD4-Positive T-Lymphocytes
PubMed: 36870379
DOI: 10.1016/j.clim.2023.109275 -
Colchicine as an Alternative First-Line Treatment of Sclerosing Mesenteritis: A Retrospective Study.Digestive Diseases and Sciences Jun 2022Sclerosing mesenteritis is a rare condition characterized by chronic inflammation and fibrotic changes of the mesentery.
BACKGROUND
Sclerosing mesenteritis is a rare condition characterized by chronic inflammation and fibrotic changes of the mesentery.
AIMS
To determine the long-term management and outcomes of patients with sclerosing mesenteritis.
METHODS
Patients with biopsy-proven sclerosing mesenteritis at the Mayo Clinic between January 2006 and December 2016 were identified. Clinical data were collected retrospectively.
RESULTS
One hundred and three patients were identified, median age 68.0 years (range 35.0-85.3). Most patients were symptomatic (87.4%) at presentation. Patients received no treatment (52.4%), medical therapy (42.7%) or surgery (4.9%) on initial diagnosis. The most common initial regimens were prednisone plus tamoxifen (41.9%), prednisone alone (23.3%), and prednisone plus colchicine (11.6%) with 55.6%, 57.2%, and 60% of patients improving, respectively, p = 0.85 for a difference in response rates. At least half of the patients responded to prednisone plus tamoxifen, prednisone plus colchicine, or prednisone alone at 6.0, 7.2, and 8.4 months, respectively. At a median follow-up of 45.6 months (95% CI 24.1-69.7), 65.4% of patients were receiving medical therapy. Of those receiving tamoxifen-based, steroid-based, or steroid-sparing regimens, 100%, 87.5%, and 77.8% had improved by their last follow-up appointment respectively, p = 0.15.
CONCLUSION
Prednisone plus colchicine has a similar efficacy to prednisone plus tamoxifen for the initial and long-term treatment of sclerosing mesenteritis. The majority of patients were initiated on medical therapy over the long term with most reporting symptomatic improvement within a year. Death from SM was rare.
Topics: Adult; Aged; Aged, 80 and over; Colchicine; Humans; Mesentery; Middle Aged; Panniculitis, Peritoneal; Prednisone; Retrospective Studies; Tamoxifen
PubMed: 34086165
DOI: 10.1007/s10620-021-07081-4 -
Journal of the College of Physicians... Mar 2022The aim of this study was to evaluate the efficacy and safety of prednisone monotherapy for phospholipase A2 receptor (PLA2R)-associated idiopathic membranous...
The aim of this study was to evaluate the efficacy and safety of prednisone monotherapy for phospholipase A2 receptor (PLA2R)-associated idiopathic membranous nephropathy (IMN). This was a retrospective cohort study involving 32 patients enrolled between January 2017 and June 2019 at Beijing Friendship Hospital, Capital Medical University, Beijing, China. Seventeen patients received prednisone monotherapy, and 15 received the Ponticelli regimen. The primary outcome was nephrotic syndrome remission at 12th month. The secondary outcomes were the incidence of adverse events and recurrence over the 12-month follow-up. At 12th month, 16/17 patients (94.1%) in the prednisone monotherapy group and 14/15 patients (93.3%) in the Ponticelli regimen group achieved remission (p = 0.19). The adverse events occurred in 9/17 and 9/15 of the patients receiving prednisone monotherapy and the Ponticelli regimen, respectively (p = 0.74). Four and three patients relapsed in the prednisone monotherapy and Ponticelli regimen groups, respectively (p = 0.99). Initial prednisone monotherapy had similar efficacy and safety compared with the Ponticelli regimen for PLA2R-associated IMN. Key Words: PLA2R-associated idiopathic membranous nephropathy, Ponticelli regimen, Prednisone monotherapy.
Topics: Autoantibodies; Glomerulonephritis, Membranous; Humans; Immunosuppressive Agents; Prednisone; Receptors, Phospholipase A2; Retrospective Studies
PubMed: 35148603
DOI: 10.29271/jcpsp.2022.03.404 -
Neurology Aug 2020To examine whether sustained minimal manifestation status (MMS) with complete withdrawal of prednisone is better achieved in thymectomized patients with myasthenia... (Comparative Study)
Comparative Study Randomized Controlled Trial
OBJECTIVE
To examine whether sustained minimal manifestation status (MMS) with complete withdrawal of prednisone is better achieved in thymectomized patients with myasthenia gravis (MG).
METHODS
This study is a post hoc analysis of data from a randomized trial of thymectomy in MG (Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy [MGTX]). MGTX was a multicenter, randomized, rater-blinded 3-year trial that was followed by a voluntary 2-year extension for patients with acetylcholine receptor (AChR) antibody-positive MG without thymoma. Patients were randomized 1:1 to thymectomy plus prednisone vs prednisone alone. Participants were age 18-65 years at enrollment with disease duration less than 5 years. All patients received oral prednisone titrated up to 100 mg on alternate days until they achieved MMS, which prompted a standardized prednisone taper as long as MMS was maintained. The achievement rate of sustained MMS (no symptoms of MG for 6 months) with complete withdrawal of prednisone was compared between the thymectomy plus prednisone and prednisone alone groups.
RESULTS
Patients with MG in the thymectomy plus prednisone group achieved sustained MMS with complete withdrawal of prednisone more frequently (64% vs 38%) and quickly compared to the prednisone alone group (median time 30 months vs no median time achieved, < 0.001) over the 5-year study period. Prednisone-associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone.
CONCLUSIONS
Thymectomy benefits patients with MG by increasing the likelihood of achieving sustained MMS with complete withdrawal of prednisone.
CLINICALTRIALSGOV IDENTIFIER
NCT00294658.
CLASSIFICATION OF EVIDENCE
This study provides Class II evidence that for patients with generalized MG with AChR antibody, those receiving thymectomy plus prednisone are more likely to attain sustained MMS and complete prednisone withdrawal than those on prednisone alone.
Topics: Adolescent; Adult; Animals; Combined Modality Therapy; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myasthenia Gravis; Prednisone; Rats; Single-Blind Method; Substance Withdrawal Syndrome; Thymectomy; Thymoma; Thymus Neoplasms; Young Adult
PubMed: 32611638
DOI: 10.1212/WNL.0000000000010031 -
Current Rheumatology Reports Mar 2015The association between antiphospholipid antibodies (aPL) and clinical problems goes beyond what is stated in the antiphospholipid syndrome (APS) classification... (Review)
Review
The association between antiphospholipid antibodies (aPL) and clinical problems goes beyond what is stated in the antiphospholipid syndrome (APS) classification criteria, namely thrombosis and pregnancy morbidity, and thrombocytopenia is the most common non-criteria hematologic manifestation of aPL with a frequency ranging from 20 to 50 %. Thrombocytopenia is rarely severe, and hemorrhage is far less common than thrombosis. However, when anticoagulation is considered, it may constitute a clinical problem with increased bleeding risk. Furthermore, thrombocytopenia represents a risk factor for thrombosis in aPL-positive patients. Therefore, it is important to understand the pathogenesis and the clinical associations of thrombocytopenia to build the right medical approach in aPL-positive patients. In this paper, we review the literature on aPL/APS-associated thrombocytopenia and briefly discuss the other conditions that can result in thrombocytopenia as they have commonalities with APS and their recognition is important to establish the most appropriate treatment strategy.
Topics: Antiphospholipid Syndrome; Glucocorticoids; Humans; Immunoglobulins, Intravenous; Prednisone; Thrombocytopenia; Treatment Outcome
PubMed: 25740703
DOI: 10.1007/s11926-014-0494-8