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Evaluate safety of guselkumab (monoclonal antibody targeting IL-23p19) in psoriatic arthritis (PsA) patients through 1year (1Y) of the Phase-3 DISCOVER-1&2 trials.
Patients with active PsA (N=1120; biologic-naïve except the118 TNFi-treated DISCOVER-1 patients) were randomized to subcutaneous guselkumab 100 mg every 4 weeks (Q4W) or at Week 0, Week4, then Q8W; or placebo. At Week24, placebo patients switched to guselkumab 100 mg Q4W. Treatment continued through 1Y and 2Y for DISCOVER-1&2, respectively. In this pooled analysis, patients with ≥1 adverse event (AE) through 1Y were standardized for 100 patient-years of follow-up [100PY]).
Through Week24, AEs were consistent between placebo- and guselkumab (Q4W+Q8W)-treated patients AEs 143/100PY and 151/100PY; serious AEs 7.1/100PY and 4.4/100PY; AEs leading to study agent discontinuation 4.1/100PY and 3.8/100PY, respectively. Through 1Y, no active tuberculosis, opportunistic infections, or inflammatory bowel disease, and low rates of malignancy and major adverse cardiovascular events, were observed in guselkumab-treated patients. Injection-site reactions occurred in 1-2%, and antibodies to guselkumab in 4.5% of guselkumab-treated patients through 1Y; the vast majority of antibodies to guselkumab were non-neutralizing. read more Serum hepatic transaminase elevations (more common with Q4W than Q8W) and decreased neutrophil counts were generally mild, transient, and did not require treatment discontinuation, with minimal change from Week24 to 1Y.
Guselkumab 100 mg Q4W and Q8W were well tolerated in PsA patients, with no new safety concerns through 1Y of the Phase-3 DISCOVER trials. Guselkumab safety through 1Y in PsA patients is consistent with that established in guselkumab-treated psoriasis patients.
Guselkumab 100 mg Q4W and Q8W were well tolerated in PsA patients, with no new safety concerns through 1Y of the Phase-3 DISCOVER trials. Guselkumab safety through 1Y in PsA patients is consistent with that established in guselkumab-treated psoriasis patients.
To evaluate the clinical and demographic characteristics of patients with juvenile idiopathic arthritis ( JIA) in Chile and compare treatments and outcomes before and after the introduction in 2010 of the Explicit Health Guarantees (GES) for JIA, a national universal access program for diagnosis and treatment of this condition.
The clinical records of 280 patients with JIA followed at a private tertiary academic health network between 2007 and 2018 were reviewed.
Seventy percent of patients with JIA were female, mean age at diagnosis was 8.5 ± 4.8 years and mean follow-up was 4.0 ± 3.7 years. After GES implementation (post-GES), time to evaluation by pediatric rheumatologist and diagnostic delay were significantly reduced (15.0 ± 4.5 vs 9.0 ± 4.2 months,
= 0.004). In addition, use of magnetic resonance imaging significantly increased post-GES (
< 0.001). In terms of JIA treatments, before GES implementation, no patients received biologics. Of the 67 patients diagnosed before 2010 with continued rates of uveitis complications in Chilean children with JIA.The number of cited authors per publication has increased substantially over time in the field of medicine.1,2 This trend of "authorship inflation" has been observed in high-impact medical journals1 and multiple medical subspecialties,2 but to our knowledge has yet to be assessed in the field of rheumatology.
Sjögren's Syndrome is a common, autoimmune disease primarily affecting the eyes and mouth. With no single gold standard test for its diagnosis, accurate identification of patients with Sjögren's Syndrome continues to be challenging. We aimed to assess the correlation of ocular and oral symptoms of dryness with objective measures in order to evaluate reliability in the screening of primary Sjögren's Syndrome (pSS) in clinical practice.
We conducted a cross sectional analysis of pre-screened pSS and sicca control patients assessed in the Multidisciplinary Sjögren's Clinic at the University Health Network in Toronto. The signs, symptoms and objective measure of oral and ocular dryness and damage of each patient were prospectively recorded using a standardized protocol.
Subjective measures of severity for xerophthalmia and xerostomia correlated in general with objective severity. Oral symptoms tend to have a stronger correlation with objective findings than ocular symptoms. Many patients with few or insignit untreated.Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with a prevalence of approximately 1 in 1000.1 It occurs 9 times more commonly in women than men and is more common in some ethnic groups, notably in people of African/Caribbean ethnicity.In 2018, an estimated 269 million people used some form of illicit drugs worldwide, with 58 million using opioids.1 In that same year, 35.6 million people were reported to suffer from drug use disorders.1.
Tocilizumab (TCZ) has shown similar efficacy when used as monotherapy as in combination with other treatments for rheumatoid arthritis (RA) in randomized controlled trials (RCTs). We derived a remission prediction score for TCZ monotherapy (TCZm) using RCT data and performed an external validation of the prediction score using real-world data (RWD).
We identified patients in the Corrona RA registry who used TCZm (n = 452), and matched the design and patients from 4 RCTs used in previous work (n = 853). Patients were followed to determine remission status at 24 weeks. We compared the performance of remission prediction models in RWD, first based on variables determined in our prior work in RCTs, and then using an extended variable set, comparing logistic regression and random forest models. We included patients on other biologic disease-modifying antirheumatic drug monotherapies (bDMARDm) to improve prediction.
The fraction of patients observed reaching remission on TCZm by their follow-up visit was 12% (n = 53) in RWD vs 15% (n = 127) in RCTs. Discrimination was good in RWD for the risk score developed in RCTs, with area under the receiver-operating characteristic curve (AUROC) of 0.69 (95% CI 0.62-0.75). Fitting the same logistic regression model to all bDMARDm patients in the RWD improved the AUROC on held-out TCZm patients to 0.72 (95% CI 0.63-0.81). Extending the variable set and adding regularization further increased it to 0.76 (95% CI 0.67-0.84).
The remission prediction scores, derived in RCTs, discriminated patients in RWD about as well as in RCTs. Discrimination was further improved by retraining models on RWD.
The remission prediction scores, derived in RCTs, discriminated patients in RWD about as well as in RCTs. Discrimination was further improved by retraining models on RWD.
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