Lana Pine

Adverse events were significantly more frequently reported by pregnant patients when compared with non-pregnant patients. However, no differences were observed when comparing pregnant patients with autoimmune disease and healthy controls.

The results of the study provide a proof of concept for upadacitinib treatment in patients with systemic lupus erythematosus.

Patients treated with upadacitinib maintained greater improvements in SLE disease activity, lupus flares, and time to first flare when compared with the placebo cohort.

Data indicate dazodalibep has the potential to address unmet therapeutic needs for patients with Sjögren’s syndrome.

The biosimilars were equivalent with the biologic regarding both ACR20 response achievement and change of Health Assessment Questionnaire-Disability Index (HAQ-DI) scores at month 6.

At the 12-month mark, opioid discontinuation occurred in 29% of patients in the intervention cohort compared with only 7% in the usual care group.

The approval was based on a comprehensive assortment of studies which showed adalimumab-aaty was comparable to the reference product, adalimumab.

The approval was based on data from a pharmacodynamic study which showed nalmefene provided a fast onset of reversal of respiratory depression from the synthetic opioid remifentanil.

The US Food and Drug Administration (FDA) has approved the adalimumab-adbm (Cyltezo) autoinjector pen ahead of the July 1 commercial launch.

During the study follow-up period, 74.5% of switchers and 51.3% of infliximab-naïve patients remained on ABP 710 treatment without a treatment gap.

The primary pharmacokinetic analysis proved equivalence between MSB11022-acetate and adalimumab.

The sensitivity for colorectal cancer detection of the blood-based test was 83%, meeting the co-primary sensitivity endpoint.

The mean number of required reinterventions was significantly lower in the patients who received a direct endoscopic necrosectomy at index session when compared with patients who received the step-up treatment approach.

Regardless of a prior history of swallowed topical corticosteroids, dupilumab was proven to be an effective treatment in patients with eosinophilic esophagitis.

Rates of key safety events, such as malignancies and major adverse cardiovascular events, were comparable among patients receiving placebo and ustekinumab.

Patients with IBD who were treated with advanced therapies who obtained clinical remission had 1.6 times more likely to maintain remission when compared with those who achieved clinical response without remission.

A proportion of patients reported triggering or worsening symptoms after a meal, with the largest proportion experiencing bloating or distention, followed by abdominal pain or discomfort, and epigastric pain.

No statistically significant differences in infusion reaction, serious reaction, or immunogenicity rates were identified between patients switching to an infliximab biosimilar and those who continued treatment on the originator.

No statically significant differences in ESR, CRP, TNF levels, and albumin were observed pre- and post-switch from the infliximab originator to the biosimilar.

Clinical outcomes of lab values were not statistically different in changes from baseline to 12 months between children with inflammatory bowel disease initiated on the TNF originator or biosimilar.

Most patients remained on infliximab biosimilars during the follow-up period and the number of switches was not independently linked to infliximab persistence after adjusting for confounders.

The biosimilars month in review highlights the positive safety and efficacy data of 3 biosimilars used to treat rheumatic diseases, gastroenterologists discuss the risks and benefits of prescribing biosimilars to their patients, and physicians emphasize the importance of patient education.

The Inflation Reduction Act contains a provision that boosts reimbursement to physicians to encourage the adoption of biosimilars and allows biosimilars to have lower list prices, benefiting patients' out-of-pocket costs.

As previous studies have shown slow uptake of biosimilars, Ross Maltz, MD, and his team wanted to get a better understanding of this issue using a survey focused on pediatric gastroenterologists.

Patients receiving tocilizumab and LZM008 showed comparable pharmacokinetic properties after a single intravenous dose.

The serum glycated hemoglobin levels and the incidence of thyroid cancer in patients with type 2 diabetes in patients with type 2 diabetes were significantly higher in the observation group when compared with the control group.

At week 54, there were no significant differences in patients achieving the target exposure (5 µg/mL) between those in the monotherapy cohort and those in the combination therapy cohort.

Among pediatric gastroenterologists surveyed, most were comfortable prescribing an infliximab biosimilar to patients who were tumor necrosis factor (TNF)-naïve and switching to a biosimilar for those in clinical remission.

Unadjusted rates of hypoparathyroidism were higher in patients who underwent total thyroidectomy and parathyroidectomy at both 30 days and 6 months.

Those with ≥67% of albumin-corrected serum calcium measurements outside of the study-defined limits had 1.9-fold higher odds of experiencing a cardiovascular event compared with patients with <33% of calcium measurements outside the range.