UNASSIGNED: In steroid-refractory acute, severe, ulcerative colitis (ASUC), salvage medical therapy with infliximab is recommended to reduce the risk of colectomy. However, the evidence supporting this practice is based on cohorts naïve to biologics. Consequently, the management of patients on biologic or small molecule therapy (BST) with ASUC is not well defined.
UNASSIGNED: We conducted a retrospective chart review of patients admitted with ASUC to Mount Sinai Hospital (MSH) in Toronto, Ontario from January 2018 until January 2022. Included subjects were considered to be on BST if they had received a dose of these agents within 56 days prior to admission. Our outcomes of interest included the mean difference in hospital length of stay (HLOS), rates of surgical consultation, rates of inpatient colectomies, and 90-day readmission rates between the 2 groups.
UNASSIGNED: Of the 185 admissions for ASUC, 76 were on BST prior to admission and 109 were not. Baseline characteristics were similar between the 2 groups. There were no significant differences in hospital length of stay (7.46 days vs 7.45 days P = .52) or in-hospital colectomy rates between the 2 groups. Patients on BST had higher rates of surgical consultation (36.8% vs 8.3% P < .01) and 90-day readmission rates (26.3% vs 13.8% P = .03).
UNASSIGNED: We did not identify significant differences in the majority of our outcomes between the 2 groups. However, patients on BST were more likely to receive a surgical consultation during their admission and had higher rates of readmission at 90 days. Further studies evaluating the underlying factors that contribute to readmission in patients on BST in hospitals are needed.

暂无摘要。

UNASSIGNED: This study aimed to evaluate adherence to subcutaneous biologic therapy and impact of nonadherence including risk factors and outcomes in academic centers with integrated specialty pharmacies for patients with inflammatory bowel disease (IBD).
UNASSIGNED: This was a multicenter, retrospective cohort analysis of patients aged ≥18 years receiving care in 3 tertiary care outpatient IBD clinics with integrated specialty pharmacies. Subjects were prescribed injectable anti-TNF therapy (adalimumab, certolizumab, golimumab) or anti-IL 12/23 therapy (ustekinumab) with at least 3 consecutive prescription claims. The primary outcomes were medication possession ratio (MPR), percent achieving optimal adherence (MPR > 0.86); in addition, we sought to verify a prior risk factor model including smoking status, narcotic use, psychiatric history, and prior biologic use. Secondary outcomes included emergency department visits (ED) and IBD-related hospitalizations. Statistical analysis was performed using Wilcox rank sum test, Pearson\'s Chi-squared test, and logistic regression model as an unordered, factor variable to flexibly estimate the probabilities of adherence.
UNASSIGNED: Six hundred eight subjects were included. Overall median MPR was 0.95 (interquartile range 0.47, 1) and adherence was 68%-70%. When the number of risk factors for nonadherence increased, the likelihood of nonadherence increased (P < .05). In unadjusted and adjusted analysis, nonadherence increased the likelihood of ED visits [rate ratio 1.45 (95% confidence interval 1.05, 1.97)] and hospitalizations [rate ratio 1.60 (95% confidence interval 1.16, 2.10)].
UNASSIGNED: Academic centers with integrated pharmacies had high adherence. Prior risk factors for nonadherence remained significant in this multicenter model. Nonadherence was associated with higher likelihood of hospitalizations and ED visits.

UNASSIGNED: Biological medications have significantly improved the prognosis of psoriasis patients. All biological drugs (except infliximab) for psoriasis require subcutaneous (SC) administration. Adverse events of biologic drug treatment include injection site reactions. ISRs are a local phenomenon characterized by swelling, erythema, pruritus, and pain around the injection site.
UNASSIGNED: We conducted a review to analyze the differences between the ISRs of various biologics approved for psoriasis. Specifically, the review focused on anti-TNF-α, anti-IL12/23, anti-IL-17, and anti-IL-23 drugs.
UNASSIGNED: Etanercept and adalimumab have reported ISR rates of 37% and 20%, respectively, with erythema, pruritus, pain, and irritation being the most common. Citrate free (CF) solution and thinner needles have reduced ISR associated with adalimumab. Ustekinumab showed a low risk of ISR. Regarding secukinumab and ixekizumab, pain was found to be the most common ISR. The introduction of CF ixekizumab formulation has shown promise in reducing ISRs associated with ixekizumab. The risk of ISR appears insignificant with bimekizumab, brodalumab, and anti-IL23 drugs, with ISR rates ranging from less than 1% to 7.1%. The choice of biologic agent should consider ISR risk. Education on injection techniques and the use of single-dose autoinjectors/pens can mitigate ISR risk.

BACKGROUND: Ustekinumab (UST) is commonly used to treat Crohn\'s disease and ulcerative colitis. However, some patients may experience diminishing response or require increased dosage. Intravenous (IV) UST maintenance is explored as a solution.
OBJECTIVE: We sought to evaluate IV UST maintenance effectiveness and safety in inflammatory bowel disease patients with partial or lost subcutaneous UST response.
METHODS: This was a multicenter retrospective study of inflammatory bowel disease patients on IV UST maintenance. Clinical response and remission at weeks 12 and 52, defined as Harvey-Bradshaw Index ≤4 for Crohn\'s disease or partial Mayo score ≤2 for ulcerative colitis. Objective markers reduction (fecal calprotectin, C-reactive protein), UST trough levels pre- and post-IV maintenance, and adverse events were assessed.
RESULTS: A total of 59 patients were included. Clinical remission at weeks 12 and 52 achieved by 47.5% and 64.3% respectively. 96.6% continued IV UST at follow-up. UST serum levels quadrupled. No adverse events reported.
CONCLUSIONS: IV UST maintenance effectively sustained remission in most patients at 52 weeks.
When patients lose response to subcutaneous ustekinumab, strategies include reinduction, interval shortening, and less explored intravenous maintenance. Its high rescue rate and safety profile make it a valuable option for managing active inflammatory bowel disease.

暂无摘要。

Background: The present investigation provides a thorough analysis of adverse drug reactions (ADRs) reported in the Database of the Spanish Pharmacovigilance System (FEDRA) for biologic medications primarily indicated for severe refractory asthma, including omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab. Our main objective was to identify ADRs not documented in the drugs\' Technical Sheets (summary of product characteristics, SmPC), potentially indicating unrecognized risks meriting pharmacovigilance attention. Methods: Data spanning from each drug\'s market introduction until 22 January 2024, were analyzed, sourced from direct submissions to the Spanish Pharmacovigilance System, industry communications, and literature reviews. We evaluated notifications impartially to ensure a comprehensive review of all the ADRs associated with these medications. Results: This investigation underlines the critical role of post-marketing surveillance in enhancing patient safety. It emphasizes the necessity for healthcare professionals to report ADRs comprehensively to foster a robust pharmacovigilance system. Furthermore, the study highlights gaps between the reported ADRs and the information provided in SmPCs, signaling potential areas for improvement in drug safety monitoring and regulatory oversight. Conclusions: Finally, these findings may contribute to informed decision making in clinical practice and regulatory policy, ultimately advancing patient care and safety in the management of severe uncontrolled asthma.

Chronic wounds pose a significant clinical challenge due to their complex pathophysiology and the burden of long-term management. Monoclonal antibodies (mAbs) are emerging as a novel therapeutic option in managing difficult wounds, although comprehensive data on their use in wound care are lacking. This study aimed to explore existing scientific knowledge of mAbs in treating chronic wounds based on a rationale of direct inhibition of the main molecules involved in the underlying inflammatory pathophysiology. We performed a literature review excluding primary inflammatory conditions with potential ulcerative outcomes (e.g., hidradenitis suppurativa). mAbs were effective in treating wounds from 16 different etiologies. The most commonly treated conditions were pyoderma gangrenosum (treated with 12 different mAbs), lipoid necrobiosis, and cutaneous vasculitis (each treated with 3 different mAbs). Fourteen mAbs were analyzed in total. Rituximab was effective in 43.75% of cases (7/16 diseases), followed by tocilizumab (25%, 4/16 diseases), and both etanercept and adalimumab (18.75%, 3/16 conditions each). mAbs offer therapeutic potential for chronic wounds unresponsive to standard treatments. However, due to the complex molecular nature of wound healing, no single target molecule can be identified. Therefore, the use of mAbs should be considered as a translational approach for limited cases of multi-resistant conditions.

Atopic dermatitis (AD) is a skin condition characterized by significant challenges and a substantial deterioration in the life quality for affected patients. The therapeutic landscape for AD has witnessed a transformative shift with the emergence of biologic therapies. Our focus centers on biologics currently undergoing phase III and IV clinical trials, deeming them to hold the highest potential for significant clinical relevance. To identify biologic drugs under development in phase III and IV clinical trials, we searched ClinicalTrials.gov. Additional relevant trials were identified through JapicCTI/ Japan Registry of Clinical Trials (jRCT) with a citation search. A search in MEDLINE and EMBASE was performed. There have been 76 clinical trials identified concerning biologic drugs: dupilumab (34 trials), lebrikizumab (14 trials), tralokinumab (10 trials), rocatinlimab (7 trials), amlitelimab (2 trials), nemolizumab (6 trials), MG-K10 (1 trial), CM310 (1 trial), 611 (1 trial). A search in MEDLINE revealed 132 articles concerning phase III and IV clinical trials for AD treatment. A total of 39 articles concerned biologic drugs covering 23 clinical trials. A search in EMBASE revealed 268 relevant articles, allowing us to identify results of an additional six clinical trials. The safety and efficacy of these biologics are comprehensively addressed in this review. This comprehensive review aims to explore the current landscape of biologic therapies for AD, delving into the latest research findings, clinical trial outcomes, and the diverse mechanisms of action employed by these novel interventions.

Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease with a profound disease burden. In recent years, the advent of biologic therapies has improved the treatment landscape for patients with moderate to severe HS. In this new therapeutic era, the role of the general practitioner (GP) in HS treatment is becoming more important than ever. This review discusses how to recognize and diagnose HS by detailing common symptoms. HS can also present with multiple comorbidities. The GP\'s role in screening for and treating these important comorbidities is pivotal. This review highlights the HS treatment landscape, with a specific focus on what the GP can recommend. The three approved biologics for treating HS include adalimumab, secukinumab and bimekizumab; the benefits and concerns of biologics in everyday clinical practice are detailed. In summary, this review serves as a HS management guide for GPs, with a particular focus on the biologic treatment landscape.