title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Consent for publication | Not applicable. | PMC10403909 | ||
Competing interests | NB | NT has received honoraria from Taiho. HH has received honoraria form Eli Lilly and Taiho, and research grant from Taiho. KN has received a consulting fee (paid to the university) from Eli Lilly. KH has received research grant from Taiho. TM (Toshiki Masuishi) have no conflicts of interest to declare. TM (Toshihiko Mats... | PMC10403909 | |
References | PMC10403909 | |||
Background | neuroinflammation, inflammation, schizophrenia experience cognitive impairment, herpes virus infection, schizophrenic | HERPES VIRUS INFECTION, INFLAMMATION | Patients with schizophrenia experience cognitive impairment, which could be related to neuroinflammation in the hippocampus. The cause for such hippocampal inflammation is still unknown, but it has been suggested that herpes virus infection is involved. This study therefore aimed to determine whether add-on treatment o... | PMC10719624 |
Methods | schizophrenia, Neuroinflammation, active psychotic symptoms | We performed a double-blind monocenter study in 24 male and female patients with schizophrenia, experiencing active psychotic symptoms. Patients were orally treated with the anti-viral drug valaciclovir for seven consecutive days (8 g/day). Neuroinflammation was measured with Positron Emission Tomography using the tran... | PMC10719624 | |
Results | TSPO | Valaciclovir treatment resulted in reduced TSPO binding (39%) in the hippocampus, as well as in the brainstem, frontal lobe, temporal lobe, parahippocampal gyrus, amygdala, parietal lobe, occipital lobe, insula and cingulate gyri, nucleus accumbens and thalamus (31–40%) when using binding potential (BPND) as an outcome... | PMC10719624 | |
Conclusion | psychotic, schizophrenia, neuroinflammation | We found a decreased TSPO binding following antiviral treatment, which could suggest a viral underpinning of neuroinflammation in psychotic patients. Whether this reduced neuroinflammation by treatment with valaciclovir has clinical implications and is specific for schizophrenia warrants further research. | PMC10719624 | |
Keywords | PMC10719624 | |||
Introduction | neuroinflammation, cognitive decline, herpes, psychosis, Schizophrenia, schizophrenia | DISORDER, HERPES VIRUS INFECTION, HERPES | Schizophrenia is a disabling disorder that often has a chronic intermittent course (van Os & Kapur, One factor that is suggested to be relevant in schizophrenia is neuroinflammation (Najjar & Pearlman, While findings on neuroinflammation in schizophrenia are inconsistent (Marques et al., The association between herpes ... | PMC10719624 |
Methods and materials | PMC10719624 | |||
Design | psychotic symptoms, psychiatric, neuroinflammation, schizophrenia spectrum disorder | BLIND | The study was a randomized, double blind, placebo controlled, mono-center study in which patients fulfilling the DSM-IV criteria for a schizophrenia spectrum disorder and experiencing active psychotic symptoms were treated with valaciclovir for seven days. Participants underwent two (Participants were randomly assigned... | PMC10719624 |
Participants | Participants ( | PMC10719624 | ||
Intervention | herpes encephalitis | HERPES ENCEPHALITIS, BLIND | Acyclovir is an antiviral drug that is specifically phosphorylated by herpes virus thymidine kinase and incorporated into the DNA, leading to cessation of DNA synthesis of the infected cell. In case of herpes encephalitis caused by HSV-1, intravenous therapy with a dose of approximately 2 g of acyclovir per day, depend... | PMC10719624 |
Outcome measures | The primary outcome measure of the study was the [The sample size needed was estimated using the [ | PMC10719624 | ||
Assessment of [ | PMC10719624 | |||
PET procedure | A catheter was inserted in the radial artery for arterial blood sampling after testing for collateral blood flow and injection of 1% lidocaïne. A venous catheter was placed in the antebrachial vein of the other arm, for injection of [T1-weighted MRI scans of the brain were made using a 3 T Intera MRI scanner (Philips, ... | PMC10719624 | ||
Data analysis | The list-mode data from the PET scans were reconstructed by filtered back projection into 21 successive frames (6 × 10 s, 2 × 30 s, 3 × 1 min, 2 × 2 min, 2 × 3 min, 3 × 5 min, and 3 × 10 min). Attenuation correction was performed by the separate ellipse algorithm (ECAT EXACT HR + ) or by a low-dose CT (Biograph mCT). P... | PMC10719624 | ||
Assessment of clinical functioning | PMC10719624 | |||
Symptom severity | The PANSS was used to confirm inclusion criteria and to assess symptom severity before and after treatment. | PMC10719624 | ||
Cognitive functioning | schizophrenia | Cognitive functioning was assessed by a trained research physician or a research psychologist, using three cognitive tests, the 15 Word Learning Test (WLT), the Continuous Performance Test (CPT) and the Verbal Fluency Test (VFT). Impairments on these tests were found in schizophrenia patients (Nuechterlein et al., Firs... | PMC10719624 | |
Statistical analysis | ± | Statistical analysis was performed in IBM SPSS Statistics 23. Data are reported as mean ± standard deviation. Differences in general information of the participants were assessed using ANOVA (age and duration of illness), Pearson's χ | PMC10719624 | |
Results | PMC10719624 | |||
Side effects | ADVERSE EFFECTS, SIDE EFFECTS | No serious adverse effects (SAE) were reported during this study. Side effects related to valaciclovir treatment | PMC10719624 | |
[ | The pre-treatment [Pre- and post-treatment [11C]-PK11195 binding potential in the hippocampus. *The post-treatment hippocampal [Analyses with | PMC10719624 | ||
Clinical outcomes | For the PANSS, the 15 WLT and the CPT, no pre-treatment differences were found between the placebo- and valaciclovir-treated groups (Within-group comparisons revealed no differences in the scores on the PANSS and the CPT ( | PMC10719624 | ||
Discussion | WLT, neuroinflammation, herpes, psychiatric, HSV-1 infection, psychotic symptoms, schizophrenia, TSPO | SIDE EFFECT, HERPES, CORTEX, INFLAMMATORY RESPONSE | To our knowledge, this is the first study investigating the effect of valaciclovir treatment on neuroinflammation in the hippocampus of patients with schizophrenia. Our main finding is that valaciclovir reduced neuroinflammation in the hippocampus, which could be interpreted as support for the hypothesis that actively ... | PMC10719624 |
Acknowledgements | psychosis | We very much appreciate the continuous support of the Stanley Medical Research Institute from USA and funding of our study (Trial 08-TGF-1243). The Stanley Medical Research Institute was not involved in study design, data analyses and interpretation or writing of the manuscript. PRA Health Sciences (Groningen, the Neth... | PMC10719624 | |
Financial support | This study was financed by a grant from The Stanley Medical Research Institute | PMC10719624 | ||
Conflict of interest | E.F.J. de Vries declares Institutional financial support for contracted research from Hoffmann-La Roche, Eli Lilly, Bristol Myers Squibb, Ionis Pharmaceutical, Rodin Therapeutics, Lysosomal Therapeutics, Novartis and GlaxoSmithKline. These institutes were not involved in this study. All other authors declare that there... | PMC10719624 | ||
References | PMC10719624 | |||
Methods | DILATION, IOL | This was a randomized controlled trial, conducted over a period of eight months at a monocentric site. Singleton pregnancies in nulliparous and parous patients with cephalic presentation and Bishop score ≥ 6 were enrolled in the study. One hundred participants were randomized into two groups: early amniotomy (initiatin... | PMC10212086 | |
Results | IOL | Early amniotomy reduced time to active phase by 2 hours and 46 minutes compared to the late amniotomy group (3 h 42 min vs. 6 h 28 min; p<0.0001). It also reduced time to vaginal delivery by 2 hours and 52 minutes (5 h 17 min vs. 8 h 9 min; p = 0.0003). The rate of cesarean section (CS) for failed IOL was significantly... | PMC10212086 | |
Conclusions | IOL | Early amniotomy in IOL significantly shortens the time to active phase as well as the overall duration of labor without compromising maternal and neonatal safety. | PMC10212086 | |
Data Availability | Anonymized data were uplaoded. A copy of anonymized uploaded data is now registered on figshare.com (DOI: | PMC10212086 | ||
Introduction | APL, IOL | HIGH-RISK PREGNANCIES, IOL | Induction of labor (IOL) is a common practice in obstetrics [In the USA about one in four women undergo IOL. This percentage is expected to rise due to the increasing number of high-risk pregnancies [Oxytocin and amniotomy are two methods used in IOL [There is ongoing debate about the efficacy of amniotomy in cases of ... | PMC10212086 |
Materials and methods | PMC10212086 | |||
Ethics statement | IOL | IOL | The study protocol was approved by the ethical committee of Mongi-Slim University Hospital, La Marsa, Tunisia (approval no. 01/2021). This trial was registered on clinical-trials.org (NCT04731896) on January 2021.Women admitted for IOL and who met the inclusion criteria were explained the purpose of the study and were ... | PMC10212086 |
Study design and participant selection | fetal abnormalities, macrosomia, hyperstimulation, pain, HIV, hepatitis B or C | CHORIOAMNIONITIS, IOL, GROUP B, CONTRACTIONS, COVID-19 INFECTION, CAVITY, FETAL GROWTH RESTRICTION | This is a randomized controlled, non-blind trial. Participants were randomly assigned to two parallel-groups: Group A: Early amniotomy (EA) and Group B: Late amniotomy (LA). The allocation ratio was 1:1.Women admitted for IOL were considered eligible if they met the following criteria: age ≥ 18 years, a full-term (≥ 37... | PMC10212086 |
Study outcomes | APL, PPH | SECONDARY, POSTPARTUM HEMORRHAGE, POSTPARTUM FEVER | The primary outcome was the time spent between initiating the oxytocin infusion and the start of the active phase of labor (APL) defined as cervical dilatation of 5 cm [The secondary outcome included: time to vaginal delivery (VD), cesarean delivery rate, intrapartum and postpartum fever, postpartum hemorrhage (PPH), A... | PMC10212086 |
Sample size and randomization | IOL | The sample size was calculated using power calculations to detect a significant reduction in the time to APL. Based on the previous IOL performed in the department, the mean time needed to reach APL was 7± 3 hours and 36 minutes. Using an alpha error of 0.05 and 90% power, aiming to decrease by 150 min the time to APL ... | PMC10212086 | |
Statistical methods | Quantitative variables with are expressed as mean ± standard deviation (SD), Medians [1st Q- 3rd Q]. Qualitative variables are expressed as percentages. The statistical analysis was carried out using “XLSTAT 2022.3.2.1346”. Data were analyzed using Student-test, Mann-Whitney and Chi square. To compare the two groups, p... | PMC10212086 | ||
Results | A total of 521 women was screened, 100 were eligible and agreed to participate in the study. They were randomized equally into two groups: EA or LA. In LA group, in one occasion, the amniotomy was impossible. As we performed a per-protocol analysis, the patient was excluded after randomization. Ninety-nine patients wer... | PMC10212086 | ||
CONSORT 2010 flow diagram. | HIGH-RISK PREGNANCY | The baseline characteristics, high-risk pregnancy rate, and the mean gestational age are represented in | PMC10212086 | |
Independent factors affecting duration of active labor: ANCOVA analysis. | The results of the Kaplan-Meier survival analysis with log-rank test revealed that the duration of both the time to APL and the time to VD were significantly shorter in the EA group; p = 0.001 ( | PMC10212086 | ||
Kaplan Meier analysis results. | PPH, Cord prolapse | IOL | There was a significative lower rate of CS for failed IOL in EA compared to LA group (31.2% vs. 70.0%; p = 0.02). However, no significant difference between both groups regarding the overall rate of CS was observed. The main indication of CS in both groups was failed IOL.Although the difference was not statistically si... | PMC10212086 |
Discussion | APL, IOL | DILATION, IOL | The main objective of this study was to evaluate the impact of EA on the time to active phase and the duration of labor, maternal and neonatal outcomes during IOL.We observed a significant reduction in the time to APL and the overall duration of labor with EA as compared to LA in IOL. Moreover, the rate of caesareans s... | PMC10212086 |
Comparison of studies regarding early or late amniotomy during induction of labor. | PPH, IOL, labor, prolonged labor | POSTPARTUM HEMORRHAGE, IOL, PROLONGED LABOR | *: Time to active phase of laborThe question arises whether EA has an impact on the CS rate compared to late amniotomy in cases of IOL. In their meta-analysis, Kim et al reported no significant difference in the rate of CS between early and late amniotomy groups (RR, 1.09; 95% CI, 0.80–1.49) [Induction of labor (IOL) h... | PMC10212086 |
Conclusion | In women with a favorable cervix, Early amniotomy following induction of labor has been shown to reduce the time to active phase and the total duration of labor, as well as decrease the incidence of cesareans section due to failed Induction of labor. These benefits are observed without any significant difference in mat... | PMC10212086 | ||
Supporting information | PMC10212086 | |||
Ethical approval. | (PDF)Click here for additional data file. | PMC10212086 | ||
Study protocol. | (DOCX)Click here for additional data file. | PMC10212086 | ||
CONSORT 2010 checklist. | (DOC)Click here for additional data file. | PMC10212086 | ||
Tables and figures. | (PDF)Click here for additional data file. | PMC10212086 | ||
References | PMC10212086 | |||
Abstract | PMC9875607 | |||
Background | ANAPLASTIC THYROID CANCER, THYROID CANCER | Anaplastic thyroid cancer (ATC) is considered the most lethal thyroid cancer, with an overall 5‐year survival rate below 10%. The FDA approved a BRAF/MEK inhibitor combination for the treatment of patients with BRAF‐mutated ATC. However, effective therapeutic options for patients with wild‐type BRAF are lacking. | PMC9875607 | |
Case | ATCs, advanced/metastatic | In our phase II study, patients having advanced/metastatic solid ATCs were treated with famitinib and camrelizumab, a combination therapy involving a multi‐targeted kinase inhibitor and an anti‐PD‐1 antibody. We report a case of a patient with locally advanced unresectable ATC who underwent this combination therapy, al... | PMC9875607 | |
Conclision | To the best of our knowledge, this is the first report describing the use of famitinib and camrelizumab as a neoadjuvant treatment for ATC with wild‐type BRAF. Clinical trial for a novel neoadjuvant approach for ATC are currently open for enrollment.
Shuwen Yang, Dongmei Ji, Fen Xue are co‐first authors. | PMC9875607 | ||
INTRODUCTION | ATCs, Thyroid cancer, aggressive disease, thyroid cancer | THYROID CANCER, ANAPLASTIC THYROID CANCER, THYROID CANCER | Anaplastic thyroid cancer (ATC) is an extremely aggressive disease. It originates from follicular thyroid cells. It is the most dedifferentiated subtype of thyroid cancer and does not retain any biological characteristics of the follicular cells. Thyroid cancer stem cells can also play a role in the initiation and grow... | PMC9875607 |
CASE DESCRIPTION | tumor, isodose, dyspnea, Tumor, calcification, Necrosis, pain, Tumors, NCT04521348, thyroid cancer, Cancer | THYROID CARCINOMA, TUMOR, DEGENERATION, METASTASIS, TUMOR, HYPERTENSION, DISEASE, NECROSIS, TUMORS, MAY, INFLAMMATORY INFILTRATION, CERVICAL MASS, ONCOLOGY, THYROID CANCER, DESMOPLASIA, CANCER | A 51‐year‐old man inadvertently noticed a cervical mass that had been growing rapidly for 1 month. On May 26, 2020, the patient went to the outpatient department of Fudan University Shanghai Cancer Center. He had no dyspnea and was in good clinical condition with an Eastern Cooperative Oncology Group performance status... | PMC9875607 |
DISCUSSION | dysphagia, aggressive thyroid cancers, tumor, dyspnea, pembrolizumab, hoarseness, neutropenia, toxicities, Anaplastic thyroid cancer, airway distress, deaths, hypertension, thyroid cancer | DYSPHAGIA, LEUKOCYTOPENIA, TUMOR, NEUTROPENIA, HYPERTENSION, THYROID, DISEASE, ANAPLASTIC THYROID CANCER, SOLID TUMORS, THYROID NODULE, THROMBOCYTOPENIA, MALIGNANCIES, THYROID CANCER, THYROID CANCERS | Anaplastic thyroid cancer is considered the most lethal thyroid cancer, accounting for 38%–50% of all deaths related to thyroid cancers. The overall 5‐year survival rate for ATC is below 10%Anaplastic thyroid cancer often presents with severe symptoms including airway distress, hoarseness, dyspnea, and dysphagia due to... | PMC9875607 |
AUTHOR CONTRIBUTIONS | PMC9875607 | |||
CONFLICT OF INTEREST | The authors have stated explicitly that there are no conflicts of interest in connection with this article. | PMC9875607 | ||
ETHICS STATEMENT | Cancer | CANCER | All experiments were approved by Fudan University Shanghai Cancer Center institutional ethics committee (1910208‐17). Written informed consent was obtained from the patient for publication of this case report and any accompanying images. | PMC9875607 |
ACKNOWLEDGMENTS | Not applicable. | PMC9875607 | ||
DATA AVAILABILITY STATEMENT | Not applicable. | PMC9875607 | ||
REFERENCES | PMC9875607 | |||
Key Points | PMC10311390 | |||
Question | rheumatoid arthritis | RHEUMATOID ARTHRITIS | What is the effectiveness of adalimumab (ADA) compared with tofacitinib (TOF) for treatment of rheumatoid arthritis in routine clinical practice? | PMC10311390 |
Findings | rheumatoid arthritis | RHEUMATOID ARTHRITIS | In this comparative effectiveness study of 842 patients with rheumatoid arthritis in Australia, TOF was favored slightly at 3 months vs ADA, but there was no difference in scores between patients receiving TOF and those receiving ADA at 9 months. | PMC10311390 |
Meaning | This study showed similar treatment effects for TOF and ADA, which is consistent with data from a randomized trial and current European Alliance of Associations for Rheumatology treatment guidelines. | PMC10311390 | ||
Importance | rheumatoid arthritis, RA | RHEUMATOID ARTHRITIS | There is a need for observational studies to supplement evidence from clinical trials, and the target trial emulation (TTE) framework can help avoid biases that can be introduced when treatments are compared crudely using observational data by applying design principles for randomized clinical trials. Adalimumab (ADA) ... | PMC10311390 |
Objective | RA | To emulate a randomized clinical trial comparing ADA vs TOF in patients with RA who were new users of a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD). | PMC10311390 | |
Design, Setting, and Participants | RA | DISEASE | This comparative effectiveness study emulating a randomized clinical trial of ADA vs TOF included Australian adults aged 18 years or older with RA in the Optimising Patient Outcomes in Australian Rheumatology (OPAL) data set. Patients were included if they initiated ADA or TOF between October 1, 2015, and April 1, 2021... | PMC10311390 |
Intervention | Treatment with either ADA (40 mg every 14 days) or TOF (10 mg daily). | PMC10311390 | ||
Main Outcomes and Measures | The main outcome was the estimated average treatment effect, defined as the difference in mean DAS28-CRP among patients receiving TOF compared with those receiving ADA at 3 and 9 months after initiating treatment. Missing DAS28-CRP data were multiply imputed. Stable balancing weights were used to account for nonrandomi... | PMC10311390 | ||
Results | A total of 842 patients were identified, including 569 treated with ADA (387 [68.0%] female; median age, 56 years [IQR, 47-66 years]) and 273 treated with TOF (201 [73.6%] female; median age, 59 years [IQR, 51-68 years]). After applying stable balancing weights, mean DAS28-CRP in the ADA group was 5.3 (95% CI, 5.2-5.4)... | PMC10311390 | ||
Conclusions and Relevance | REMISSION | In this study, there was a modest but statistically significant reduction in DAS28-CRP at 3 months for patients receiving TOF compared with those receiving ADA and no difference between treatment groups at 9 months. Three months of treatment with either drug led to clinically relevant average reductions in mean DAS28-C... | PMC10311390 | |
Introduction | rheumatoid arthritis, RA, tumor necrosis | RHEUMATOID ARTHRITIS, DISEASE, TUMOR NECROSIS | In the past 20 years, the availability of tumor necrosis factor inhibitors (TNFis) and other biologic disease-modifying antirheumatic drugs (bDMARDs) has transformed treatment for patients with rheumatoid arthritis (RA). More recently, targeted synthetic DMARDs (tsDMARDs), including janus kinase inhibitors (JAKis), hav... | PMC10311390 |
Methods | Detailed technical methods of this comparative effectiveness study are described in eMethods 1 through 7 and the eAppendix in | PMC10311390 | ||
Design | The prespecified protocol for the target trial to be emulated is described in eMethods 1 in | PMC10311390 | ||
Participants | RA | Eligible patients in the emulated target trial were adults aged 18 years or older who were diagnosed with RA; whose first visit occurred between April 1, 2015, and January 1, 2021; who had no prior recorded b/tsDMARD; who had at least 6 months from their first recorded visit until baseline; and who had at least 6 month... | PMC10311390 | |
Interventions | ADVERSE EVENT | Patients initiated treatment with either ADA (40 mg every 14 days) or TOF (10 mg daily) and, in the target trial, would be expected to continue treatment during follow-up unless an adverse event or contraindication occurred. The limited duration of availability of the biosimilar for ADA meant that all ADA interventions... | PMC10311390 | |
End Point | DISEASE | The primary outcome was disease activity at 3 and 9 months after initiating treatment. The average treatment effect (ATE) was defined as the difference in mean DAS28-CRP among patients receiving TOF compared with those receiving ADA at 3 and 9 months.These time points were selected because joint counts and pathologic m... | PMC10311390 | |
Setting and Data Source | fits, RA, rheumatic | DISEASE, PATHOLOGY | This analysis used the multicenter OPAL data set, which includes the EMRs for 216 138 patients with rheumatic conditions treated by 112 rheumatologists across Australia at 43 different clinics since 2004. In Australia, government reimbursement is available for b/tsDMARDs for patients with moderate to severe disease who... | PMC10311390 |
Safety | ADVERSE REACTIONS, ADVERSE REACTION | Treatment cessations due to an adverse reaction were described for all patients who satisfied the inclusion criteria. Treating physicians have discretion to record an adverse reaction to a medication in the EMR, and there may have been unrecorded adverse reactions. All recorded adverse reactions that were considered mo... | PMC10311390 | |
Patient Involvement | Patients were not involved in the design of this study or consulted during selection of outcomes or the interpretation of findings. Patients will be involved in the dissemination of this research. | PMC10311390 | ||
Statistical Analysis | DISEASE | A multistep method was developed to address the challenges of missing disease activity data and nonrandomized treatment assignment. Analysis that only uses complete cases could lead to selection bias, and thus, multiple imputation was used instead of complete-case analysis. An overview of the methods is presented in | PMC10311390 | |
Multistep Analytical Procedure Developed to Estimate the Average Treatment Effect (ATE) of Tofacitinib (TOF) Compared With Adalimumab (ADA) | Random forest multiple imputation (RF-MI) was used to impute plausible values for missing data in the original electronic medical record (EMR) data set. Stable balancing weights (SBWs) were used to balance the baseline characteristics of the ADA and TOF treatment groups. Gray squares in the grid that represents EMR ind... | PMC10311390 | ||
Results | PMC10311390 | |||
Patients | RA | Of the 52 338 patients with RA in the OPAL data set, 842 eligible b/tsDMARD-naive patients who were new starters of ADA (n = 569; 387 [68.0%] female; 175 [30.8%] male; median age, 56 years [IQR, 47-66 years]) or TOF (n = 273; 201 [73.6%] female; 72 [26.4%] male; median age, 59 years [IQR, 51-68 years]) were identified ... | PMC10311390 | |
Baseline Data | Before SBWs were applied, there were small differences between the treatment groups ( | PMC10311390 | ||
Baseline Characteristics of Patients With RA Treated With ADA or TOF | RHEUMATOID ARTHRITIS, DISEASE | Abbreviations: ADA, adalimumab; b/tsDMARDs, biologic or targeted synthetic disease-modifying antirheumatic drugs; CRP, C-reactive protein; DAS28-CRP, disease activity score in 28 joints using C-reactive protein; EMR, electronic medical record; ESR, erythrocyte sedimentation rate; RA, rheumatoid arthritis; SJC28, swolle... | PMC10311390 | |
Standardized Mean Difference in Baseline Characteristics of Adalimumab (ADA) and Tofacitinib (TOF) Treatment Groups Before and After Weighting | DISEASE | Error bars for disease activity score in 28 joints using C-reactive protein (DAS28-CRP) represent the minimum and maximum standardized mean difference values across 10 imputed data sets. The standardized mean difference is the difference between treatment groups in the mean for each covariate divided by its SD for the ... | PMC10311390 | |
Estimated Comparative Effectiveness | After weighting, mean DAS28-CRP decreased from 5.3 (95% CI, 5.2-5.4) at baseline to 2.6 (95% CI, 2.5-2.7) at 3 months and 2.3 (95% CI, 2.2-2.4) at 9 months in the ADA group (eResults 5 in The ATE for TOF compared with ADA was −0.2 (95% CI, −0.4 to −0.03; | PMC10311390 | ||
Estimated Average Treatment Effect (ATE) for Tofacitinib (TOF) Compared With Adalimumab (ADA) at 3 and 9 Months | Squares represent ATEs, with horizontal lines representing 95% CIs based on bootstrap distributions of the estimates. | PMC10311390 | ||
Safety | cancer | ADVERSE REACTIONS, CANCER | Due to recent concerns about MACE and cancer associated with JAKi drugs,There were no adverse reactions recorded using | PMC10311390 |
Discussion | cancer, RA | CANCER, DISEASE | In this comparative effectiveness study using the TTE framework, we found a modest but statistically significant reduction in disease activity associated with TOF compared with ADA at 3 months and no difference between drugs at 9 months in patients with RA who were b/tsDMARD naive. These results may be generalizable to... | PMC10311390 |
Limitations | DISEASE | As an analysis of observational data, the challenges of missing outcomes data and nonrandomized treatment assignment were possible limitations to this study that may impact interpretation of the generalizability of the results. Our analysis relied on some assumptions, and violation of these would limit the reliability ... | PMC10311390 | |
Conclusions | REMISSION | In this comparative effectiveness study, DAS28-CRP was significantly lower at 3 months for patients treated with TOF compared with ADA. However, 3 months of treatment with either drug led to substantive reductions in mean DAS28-CRP, consistent with remission. There was no difference in DAS28-CRP between patients receiv... | PMC10311390 |
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