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Summary: Background: Previous studies highlighted a more extensive phenotype for paediatric‐onset than adult‐onset inflammatory bowel disease (IBD). However, most lacked long‐term follow‐up, and some were conducted before the era of biologics. Aims: The aim of this study is to compare disease characteristics and treatment exposures between paediatric‐onset and adult‐onset IBD. Methods: From a registry that periodically and uniformly retrieves demographics, disease characteristics/phenotype, and treatments, we compared the characteristics of paediatric‐onset (diagnosed at ≥6 and <18 years) and adult‐onset IBD, diagnosed during 2000–2022 and with ≥12 months follow‐up. Results: Of the 2837 patients with Crohn's disease and 1332 with ulcerative colitis, 3316 had adult‐onset and 853 paediatric‐onset IBD. The median follow‐up was 6 years. Patients with paediatric‐onset presented with more extensive disease and received more intensified therapies, including biologics and JAK inhibitors than those with adult‐onset IBD. Paediatric‐onset ulcerative colitis showed a higher prevalence of E3 extensive colitis including pancolitis and a greater requirement for systemic steroids, immunomodulators, and biologics than adult‐onset ulcerative colitis. Paediatric‐onset versus adult‐onset Crohn's disease exhibited greater L3 ileocolonic involvement and perianal disease phenotype, and higher exposure to immunomodulators and biologics. Kaplan–Meier curve and Cox proportional hazards analyses showed significantly lower 15‐year biologic‐free survival from diagnosis among those with paediatric‐onset IBD than with adult‐onset IBD (p = <0.001), indicating greater and earlier use of biologics in the former. Conclusions: Paediatric‐onset presents with more extensive disease with higher exposures to immunomodulators and biologic therapies than adult‐onset IBD. [ABSTRACT FROM AUTHOR]

Background: Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease of synovial joints, with a multifactorial etiology. Collagen triple helix repeat-containing 1 protein (CTHRC1) is a biomarker produced by fibroblast-like synoviocytes, which was shown to be highly expressed in RA patients. The study aimed to measure serum CTHRC1 level in female RA patients currently on medical treatment and its influence on the clinical and sonographic severity of the disease. Results: The patients' mean age was 43.39 ± 8.55 years and median RA disease duration of 5.5 (0.33–20) years. RA patients showed significantly higher serum CTHRC1 level [89.71 ng/ml (53.95–353.45)] in comparison to controls [87.38 ng/ml (44.47–110.3)] (U = 430, P = 0.014). Furthermore, higher serum CTHRC1 levels were recorded in seropositive versus seronegative patients (U = 76, P = 0.022) and in RA patients with severe disease activity compared to those with lower disease activity (H = 9.79, P = 0.007). Furthermore, serum CTHRC1 levels were lower in RA patients receiving biological therapy compared to those receiving conventional therapy; however, this difference did not reach statistical significance. Significant positive correlations were found between CTHRC1 and disease activity, acute-phase reactants, serological markers, functional assessment, fatigue, and erosions detected by ultrasound, while a significant negative correlation was recorded between CTHRC1 and duration of biologic intake (rs = − 0.45, P = 0.036). Furthermore, on multivariate linear regression analysis, serum CTHRC1 was the only significant predictor for higher disease activity (P = 0.028, B = 0.009, 95% CI 0.001 to 0.017). Conclusion: RA patients showed higher CTHRC1 serum levels compared to healthy controls, especially those with seropositivity and highly active disease. Furthermore, it was positively associated with poor patient functional outcome, fatigability, and erosive findings by ultrasound, thus suggesting that serum CTHRC1 can be a good predictor for high RA disease activity and possibly severity. Moreover, biological therapy could influence serum CTHRC1 levels in these patients. [ABSTRACT FROM AUTHOR]

Idiopathic inflammatory myopathies (IIMs) are a rare and heterogeneous group of chronic autoimmune disorders. Up to 40% of IIM patients have long-term sequelae and significant functional disability. Its management can be challenging and new therapies are badly needed. The small number of cases with diverse presentations and different diagnostic criteria significantly affect clinical trial results. Only IVIG has been internationally approved for IIM patients. Most clinical trials of new biologic therapies have failed to meet their primary endpoints in IIM, with only one biologic drug recommended for refractory IIM treatment (rituximab), although not approved. We review several new emerging biologic drugs, including B cell depletion therapies, abatacept, Janus kinase inhibitors, and aldesleukin. Encouragingly, some phase II randomized controlled trials have evaluated the efficacy and safety of new biologics in IIM, demonstrating an improvement in clinical and laboratory measures. [ABSTRACT FROM AUTHOR]

Objective To study the therapeutic variations of biologic and targeted synthetic DMARDs (b/tsDMARDs) between genders and across age stages in axial SpA (axSpA) patients through meta-analysis. Methods Randomized controlled trials published by PubMed, Scopus and Embase before 10 August 2023, testing the efficacy of b/tsDMARDs in axSpA, were searched and systematically reviewed. The Assessment of Spondyloarthritis International Society ≥40% improvement (ASAS40) was used as the primary outcome of treatment response. Results Only one study meet the inclusion criteria related to tsDMARDs, which was excluded from further analysis. Nine studies of bDMARDs, with 4127 patients, were included for the final analysis. When compared with placebo, both males [odds ratio (OR) 3.14 (95% CI 2.66, 3.70)] and females [OR 2.32 (95% CI 1.82, 2.82)] and younger [OR 4.00 (95% CI 2.50, 6.40)] and older [OR 2.21 (95% CI 1.15, 4.22)] patients presented significantly better responses to bDMARDs. Also, the efficacies were more evident in males [OR 1.89 (95% CI 1.56, 2.30)] and younger [OR 2.07 (95% CI 1.42, 3.02)] patients. Subgroup analysis revealed that the gender difference in efficacy was more obvious in non-radiographic axSpA (nr-axSpA) patients (P heterogeneity = 0.03, I 2 = 78.1%). Moreover, males with radiographic axSpA (r-axSpA) and nr-axSpA shared similar responses to bDMARDs (P heterogeneity = 0.87, I 2 = 0%), while females with r-axSpA showed greater response than those with nr-axSpA (P heterogeneity = 0.005, I 2 = 87.4%). Conclusions The bDMARDs were efficacious in all axSpA patients regardless of gender or age. However, the treatment responses were more evident in male and younger patients. Also, females with r-axSpA had greater responses than those with nr-axSpA, whereas no relevant difference was observed in males, indicating that the gender difference on efficacy was greater in nr-axSpA patients. [ABSTRACT FROM AUTHOR]

Objectives The objective of this study was to examine the effectiveness and drug tolerability of biological DMARD (bDMARD) and Janus kinase inhibitor (JAKi) monotherapy in patients with RA in a multicentre cohort study. Methods Patients with RA for whom bDMARD/JAKi monotherapy without conventional synthetic DMARDs has been initiated were included. Monotherapy regimens were categorized as IL-6 receptor inhibitors (IL-6Ris), cytotoxic T-lymphocyte–associated protein 4 immunoglobulin (CTLA4Ig), JAKis, or TNF inhibitors (TNFis). Multiple propensity score–based inverse probability weighting (IPW) was used to reduce selection bias. Linear mixed-effect models with IPW were used to examine changes in the DAS in 28 joints using ESR (DAS28)-ESR at 24 weeks, and drug retention was compared between monotherapy groups using IPW Cox proportional hazards models. Results A total of 849 treatment courses were included, involving 635 patients (IL-6Ris, 218; CTLA4Ig, 183; JAKis, 92; TNFis, 356). The change in DAS28-ESR at week 24 as the primary outcome was –0.93 (95% CI: –1.20 to –0.66) lower in the IL-6Ri group than in the TNFi group, while those of the CTLA4Ig and JAKi groups were similar to that of the TNFi group [–0.20 (–0.48 to 0.08), –0.25 (–0.67 to 0.16), respectively]. IL-6Ri use was associated with significantly lower overall drug discontinuation than that for TNFi use [hazard ratio = 0.55 (0.39–0.78), P  = 0.001]. Similar retention rates were identified for the CTLA4Ig and JAKi groups to that of the TNFi group. Conclusion In the analysis with IPW to reduce selection bias, IL-6Ri monotherapy was superior to TNFi monotherapy in terms of effectiveness and drug retention. No significant differences were identified between CTLA4Ig, JAKi and TNFi monotherapy. [ABSTRACT FROM AUTHOR]

Key points: Data on current practice patterns for the management of chronic rhinosinusitis with nasal polyps, including which medications are deemed by otolaryngologists to better manage patient symptoms, are limited.This study demonstrated that contemporary practice patterns are largely consistent with published clinical consensus statements.Off‐label nasal steroid irrigations and dupilumab are the most commonly used topical and systemic therapies for chronic rhinosinusitis with nasal polyps, respectively. [ABSTRACT FROM AUTHOR]

Purpose: To analyze recurrence patterns of chronic sinusitis with nasal polyposis (CRSwNP) in patients who underwent complete FESS and identify predisposing factors for different patterns of recurrence. Methods: Retrospective analysis of patients with CRSwNP who underwent complete FESS at our tertiary medical center. Recurrence patterns were classified into edema, polyp and normal endoscopy, as well as into early (within 6 months) and late recurrence. Statistical analysis to identify risk factors for recurrence included univariate, multivariate logistic regression and cox regression models. Results: 114 patients were included with an average follow-up of 27 months. 91% were categorized as type-2 inflammation. Recurrence was observed in 65.8% of patients within a mean of 12.9 months. 46.7% had polyp recurrence while 53.3% had edema recurrence. Early recurrence was observed in 41%. Serum eosinophilia > 500 cells/uL was found to be significantly associated with recurrence (RR = 1.62, p-value = 0.046), and particularly with polyp recurrence (RR = 3.9, p-value = 0.001). No predictive factors for early recurrence were identified. Edema recurrence was managed with intranasal corticosteroids while polyp recurrence required systemic therapy including biologic therapy. Conclusions: In this study, two thirds of patients experienced post operative recurrence, either mucosal edema or nasal polyps, with similar frequency during an average follow up of over 2 years. Early recurrence was noted in 41% of recurrent cases. Serum eosinophils > 500 cells/uL was the only risk factor for recurrence on multivariate analysis, more accurate markers are needed for improved treatment allocation to CRSwNP patients. [ABSTRACT FROM AUTHOR]

Purpose: Antibody therapy for chronic rhinosinusitis with nasal polyps (CRSwNP) has been established in Germany since 2019. With limited long-term data on biologic treatment for CRSwNP, we conducted a comprehensive evaluation of our 4-year data. This monocentric study aims to assess the real-world effects of this treatment on clinical course, quality of life, treatment adherence, biologic switching, dual therapy, and comorbidities. Methods: We retrospectively analysed biologic therapy data in patients with severe chronic rhinosinusitis with nasal polyps. 191 patients with CRSwNP treated with Dupilumab, Mepolizumab, or Omalizumab were observed for up to 4 years in a real-life setting. Results: We observed clear symptom improvements with few side effects. No loss of efficacy or tolerability was noted during the 4-year period. Patients reported high satisfaction compared to previous therapies, with overall improved quality of life. Revision surgery or oral steroid use during biologic therapy was rare. Some patients prolonged injection intervals or discontinued steroid nasal spray. Biologic switching occurred infrequently due to side effects or inadequate response and was generally well tolerated. Many patients reported additional positive effects such as asthma or allergy symptom improvement and reduced medication intake. Conclusion: In summary, this study confirms the potency and tolerability of biologics for CRSwNP treatment, with sustained efficacy over 4 years. Biologic switching is a viable option for inadequate response or intolerable side effects. Therapy positively impacts Th2 comorbidities, corticosteroid requirements, surgery need, and overall compliance remains high. Clinical trial registration: Project No.: 22–0802. Registry name: Biologika bei Patient*innen mit chronischer Sinusitis mit Nasenpolypen. [ABSTRACT FROM AUTHOR]

Background: For patients with psoriasis, discontinuation of biologics following remission has become more common in daily practice. Objective: We aimed to identify predictors and construct a predictive model for time to relapse following withdrawal from biologics. Methods: This 12-year, multicenter, observational cohort study was performed in six dermatology centers between February 2011 and February 2024. We identified biological treatment episodes in patients with moderate-to-severe psoriasis and included only treatment episodes in which a clinical response (≥ 50% reduction in Psoriasis Area and Severity Index score [PASI 50] from baseline) was achieved and the patient withdrew from biological therapy with a well-controlled status (PASI < 10 and ≥ 50% improvement in PASI from baseline). The primary outcome was time to relapse, which was defined as the period from the last biologic administration to relapse. An extended multivariate Cox proportional hazards analysis (Prentice–Williams–Peterson Gap time model) was used to predict relapse and generate a predictive model. Results: This study screened 1613 biological treatment episodes, and 991 treatment episodes were enrolled. The time to relapse decreased significantly as the number of previous withdrawals from biological treatment increased (p < 0.001). Similarly, the time to relapse decreased significantly as the number of previous biologics used increased (p < 0.001). The maximum PASI improvement during biological treatment decreased and the PASI score at withdrawal of biological treatment increased in parallel as the number of prior withdrawals from biologics increased. The time to relapse following withdrawal was longest for interleukin (IL)-23 inhibitors (IL-23i), followed by the IL-12/23i, IL-17 inhibitors (IL-17i), and tumor necrosis factor-α inhibitors. After adjustment, multivariate Cox regression identified the following significant predictors of relapse following withdrawal: the mechanisms of action of biologics (hazard ratio [HR] for IL-17i vs IL-12/23i, 1.59; HR for IL-23i vs IL-12/23i, 0.60), number of previous withdrawals from biological treatment (HR 1.23; 95% confidence interval [CI] 1.13‒1.33), time to achieve PASI 50 (HR 1.01; 95% CI 1.00‒1.02), maximum PASI improvement on biologics (HR 0.98; 95% CI 0.98‒0.99), and PASI at the end of therapy (HR 1.03; 95% CI 1.01‒1.05). The model had good predictive and discriminative ability. Conclusions: These results have the potential to help physicians and patients make individualized treatment decisions; information on the risk of relapse of psoriasis at specific timepoints following the withdrawal of biologics is particularly valuable for patients considering discontinuation of biologics or as-needed biologic therapy. However, the benefit and risk of repeated withdrawals of biologics should be carefully weighed, as the treatment efficacy and duration of remission decline as the number of withdrawals increases. [ABSTRACT FROM AUTHOR]

The article discusses a case series evaluating the effectiveness of bimekizumab in treating genital psoriasis (GenPs) over 52 weeks. Twelve patients with moderate-to-severe GenPs were treated with bimekizumab, showing significant improvement in their condition. The study highlights bimekizumab's sustained positive trend in managing GenPs, with patients achieving clear/almost clear status and improved quality of life. While some patients experienced minor side effects, the overall response to treatment was consistent across different sexes and prior treatment experiences. [Extracted from the article]

Background: Evidence describing the types and annual costs of biological treatments for psoriasis in Latin America is scarce. This study aimed to estimate the frequency of use and costs of biologic therapy for psoriasis in Colombia in 2019. Methods: This secondary data analysis uses the International Classification of Diseases terms associated with psoriasis, excluding those related to psoriatic arthritis, based on data from the registry of the Colombian Ministry of Health. We estimated the prevalence of psoriasis per 100,000 inhabitants; then, we retrieved the frequency of use of biologic therapy in patients with psoriasis and estimated the cost per year of each and overall therapies in 2019 in US dollars (USD). Results: There were 100,823 patients with psoriasis in Colombia in 2019, which amounts to a prevalence of 0.2% in the general population. Of those patients, 4.9% received biologic therapy, most frequently males (60%). The most commonly used biological therapies for psoriasis in Colombia in 2019 were ustekinumab (35.2%), with an annual cost per patient of $12,880 USD; adalimumab (26%), with a yearly cost per patient of $7130 USD; and secukinumab (19.8%), with an annual cost per patient of $6825 USD. Conclusion: This is the first study to describe the use and cost of biological therapy for psoriasis in Colombia. It provides valuable cost‐awareness information for the Colombian health system. [ABSTRACT FROM AUTHOR]

Objectives: Given the limited tocilizumab (TCZ) treatment data for systemic juvenile idiopathic arthritis (sJIA) in China, we evaluated the long-term efficacy and safety of TCZ in Chinese patients with sJIA. Method: In this multicentre, interventional Phase IV study, patients with sJIA and inadequate clinical response to non-steroidal anti-inflammatory drugs/corticosteroids received TCZ infusions every 2 weeks based on body weight (< 30 kg, 12 mg/kg; ≥ 30 kg, 8 mg/kg), over a 52-week open-label period and an 8-week safety follow-up period. The primary endpoint was the proportion of patients with a JIA American College of Rheumatology (ACR) 30 response and absence of fever at Week 12. Results: Sixty-two patients were enrolled and treated (12-mg/kg group, 34; 8-mg/kg group, 28). At Week 12, 87.1% (95% confidence interval 78.8%–95.4%) of patients had JIA ACR 30 response and absence of fever; Week 52 results were similar. The proportion of JIA ACR 30/50/70/90 responders rapidly increased at Week 12, up to Week 52. High-sensitivity C-reactive protein (hsCRP) levels decreased within 4 weeks; 44/58 patients (75.9%) with elevated baseline hsCRP recovered at Week 52. Childhood Health Assessment Questionnaire pain scores, disability index scores, and mean corticosteroid dose decreased over time. Height standard deviation score changes at Week 52 indicated catch-up growth. Most adverse events (AEs) were mild (serious AE incidence, 17.7%). No deaths or macrophage activation syndrome occurred. Conclusion: This is the first multicentre trial to report the efficacy and safety of TCZ in Chinese patients with sJIA at 52 weeks. No new safety concerns were found. Key points • This is the first multicentre trial providing strong evidence for tocilizumab (TCZ) treatment for systemic juvenile idiopathic arthritis (sJIA) in China. • The study reported TCZ had good efficacy and favourable safety profiles in Chinese sJIA patients in the long term (52 weeks). • TCZ treatment showed rapid disease control, which was maintained over time, catch-up growth benefits in patients, tapering and discontinuation of corticosteroids, and improved quality of life. [ABSTRACT FROM AUTHOR]

Introduction: The effects of antioxidant dietary supplements on response to biological therapies for cancer is unknown. We conducted a scoping review of the available systematic review evidence on this question. Methods and analysis: We searched six databases from inception to August 19, 2022 for systematic reviews of randomized controlled trials of antioxidant dietary supplements used by patients receiving curative chemotherapy, radiotherapy, or other biological therapy for cancer and assessing the impact of supplements on survival, treatment response, or disease progression. We focused on results from reviews at high or moderate AMSTAR-2 quality. Records were selected, data extracted, and AMSTAR-2 ratings assessed independently by two authors. Results: We found 24 systematic reviews with relevant evidence. Reviews were heterogenous in cancers, treatments, and antioxidant dietary supplements assessed. Conclusions across reviews were mixed, ranging from negative to no apparent difference to positive, but always with caveats about the limited size and quality of the evidence. One review was rated 'moderate' on AMSTAR-2; it included one small trial of vitamin C and formed no firm conclusions. Conclusions: We did not find reliable systematic review evidence on the effects of antioxidant dietary supplements upon therapies for cancer. More research is necessary to inform clinical recommendations. [ABSTRACT FROM AUTHOR]

Ankylosing spondylitis (AS), a common type of spondyloarthropathy, is a chronic inflammatory autoimmune disease that mainly affects spine joints, causing severe, chronic pain; additionally, in more advanced cases, it can cause spine fusion. Significant progress in its pathophysiology and treatment has been achieved in the last two decade. Management of ankylosing spondylitis (AS) is challenged by the progressive nature of the disease. Current drug treatment may perhaps induce a spurious state of “disease remission,” which is merely a low level of disease activity. Non-steroidal anti-inflammatory drugs are first line treatment, but over time, the disease often becomes refractory to these agents. For patients with AS, it is important and necessary to develop and implement in clinical practice therapeutic schemes that affect the pathogenesis of the disease, control the symptoms, reduce the progressive course of the disease, thereby increasing the quality of life of the patients. This is within the capabilities of biological therapies. [ABSTRACT FROM AUTHOR]

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Objective. To report pharmacokinetics (PK), immunogenicity, clinical effect, and safety of intravenous (IV) golimumab in children with active polyarticular-course juvenile idiopathic arthritis (pcJIA) who participated in A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy (GO-VIVA)'s open-label, long-term extension (LTE) through week 252. Methods. GO-VIVA participants who continued IV golimumab (80 mg/m² every 8 weeks) after week 52 were included. PK and safety were assessed through week 244 (last dose) and week 252, respectively, and clinical response through week 116. Clinical outcomes included JIA--American College of Rheumatology (ACR) responses and clinical Juvenile Arthritis Disease Activity Score in 10 joints (cJADAS10). Binary outcomes used nonresponder imputation, and other descriptive analyses used observed data. Results. Of 112/127 (88.2%) participants entering the LTE, 69 completed the week 252 visit. Median steady-state trough golimumab concentrations were generally maintained from week 52 through week 244 (range 0.3-0.6 μg/mL). Antigolimumab antibody rates were consistent through week 52 (39.2% [49/125]) and week 244 (44.8% [56/125]). Week 52 JIA-ACR 30/50/70/90 response rates (75.6% [96/127], 74% [94/127], 65.4% [83/127], and 48.8% [62/127], respectively) were generally maintained through week 116 (72.4% [92/127], 71.7% [91/127], 63.8% [81/127], and 50.4% [64/127], respectively), when the median cJADAS10 was 1.6 and 56.7% (72/127) of participants achieved cJADAS10 ≤ 5 (minimal disease activity). Rates (per 100 patient-years) of serious adverse events and serious infections through week 252 were 7.7 and 3.9, respectively. Conclusion. GO-VIVA LTE participants experienced adequate PK exposure and stable safety and immunogenicity. The majority of participants experienced no more than minimal residual disease activity. Data suggest IV golimumab treatment provided durable clinical response through week 116, with an acceptable risk-benefit profile. [ABSTRACT FROM AUTHOR]

Objective. To report real-world experience on the use of anifrolumab (ANI) in refractory systemic lupus erythematosus (SLE). Methods. The present study is a multicenter, retrospective study involving 9 Italian SLE referral centers participating in a compassionate use program for the use of ANI in adult patients with active SLE in whom all the available treatment choices failed, were not tolerated, or were contraindicated. At baseline and 1, 3, 6, 9, and 12 months of treatment, overall and organ-specific disease activity, flares, daily glucocorticoid (GC) dose, and adverse events were recorded. Results. A total of 26 patients were enrolled. At 4 weeks after starting ANI, a significant decrease in the Systemic Lupus Erythematosus Disease Activity Index 2000 (P = 0.01), Systemic Lupus Erythematosus--Disease Activity Score (P = 0.01), and physician global assessment (P = 0.001) was recorded, and the same trend was maintained over time. A significant reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index-activity (P < 0.001) and in tender (P = 0.03) and swollen (P = 0.02) joint counts was also recorded. At 3 months of follow-up, 33% of patients already achieved a remission state, whereas 46% were in Lupus Low Disease Activity State (LLDAS); at 6 months, 50% were in remission and 80% were in LLDAS. A significant reduction in the mean GC daily dose was observed, starting from week 4 (P = 0.04). A total of 4 disease flares according to the Safety of Estrogens in Lupus Erythematosus National Assessment--Systemic Lupus Erythematosus Disease Activity Index were recorded (3 mild-moderate and 1 severe). Overall, 4/20 patients with at least 24 weeks of follow-up (20%) were considered nonresponders. Conclusion. This study provides real-world experience on the use of ANI in patients with refractory SLE, confirming its rapid effectiveness and an overall acceptable safety profile. [ABSTRACT FROM AUTHOR]

Introduction: There are several treatment controversies that have emerged in spondyloarthritis and psoriatic arthritis. These are related to the nature of the conditions as well as to the use of medications. Areas covered: This review, which included a search of PubMed database as well as the references within the articles provides an overview of the nature of spondyloarthritis, controversy over the inclusion of psoriatic arthritis (PsA) as a peripheral spondyloarthritis, and a summary of current treatments for both PsA and axial spondyloarthritis (axSpA), with special emphasis on targeted therapy. The review highlights the differences in response to certain medications, particularly biologic therapy and summarizes the randomized controlled trials in psoriatic arthritis and axial spondyloarthritis providing data about the responses in table format. Expert opinion: There is a need for better outcome measures in axSpA. Currently, the measures are subjective. Imaging may be more appropriate but there is a need for research into the reliability and responsiveness of imaging techniques. In PsA, there may also be better response measures and research into the reliability and responsiveness of available measures is underway. There is also a need for novel therapies as well as biomarkers for response in both diseases. [ABSTRACT FROM AUTHOR]

Background/Objectives Methods Results Conclusions Surgical deroofing is an essential part of ongoing management of Hidradenitis Suppurativa, including persistent lesions non‐responsive to medical therapy. The variables associated with delayed wound healing after surgical deroofing are contradictory within the literature due to the inclusion of heterogeneous surgical intervention methods. We aimed to assess the predictors of time to wound healing after surgical deroofing in HS.Patients who underwent in‐office surgical deroofing between 2020 and 2024 at a single tertiary HS referral centre were included in analysis. Demographic, disease and blood variables were collected as per standard of care. Statistical analysis was performed using univariate correlation, with multiple regression performed to explore the interactions between variables and identify variables predictive of time to wound healing.A total of 270 individuals were included in the analysis. The median time to wound healing was 9.6 weeks with a range from 4 to 22 weeks. Kaplan–Meier curves demonstrated significant differences with the log rank test when comparing biologic use versus no use, normal versus abnormal CRP and normal versus abnormal haemoglobin. Cox regression analysis identified biologic use with a significant hazard ratio compared to no biologic therapy (HR = 2.512, p < 0.0001) along with baseline CRP (HR = 0.968, p < 0.0001) and baseline haemoglobin (HR = 1.052, p < 0.001).Time to wound healing after in‐office deroofing can be decreased with prior biologic therapy and markers of systemic inflammation in blood are also significantly associated with delays in healing. This correlates well with the existing literature promoting concurrent medical and surgical therapy to improve patient outcomes in HS. [ABSTRACT FROM AUTHOR]

Background: Real-world data assessing the effectiveness of biologics in patients with inflammatory bowel disease (IBD) in the Middle East are not well-established. In our study, we evaluated the effectiveness of biologic therapies in achieving clinical and endoscopic outcomes in biologic-naïve patients with IBD. Design: A retrospective chart review was conducted at two tertiary care gastroenterology centers using electronic medical records of patients with moderate-to-severe IBD. The study period was from October 2017 to October 2023. Patients who were on infliximab, adalimumab, ustekinumab, or vedolizumab for 12 months were included in the analysis. The primary outcomes were the percentage of IBD-related hospitalizations or surgeries, achieving steroid-free remission, and endoscopic remission. Results: A total of 422 patients were included in the study, of whom 264 (62.5%) patients had Crohn’s disease (CD) and 158 (39%) had ulcerative colitis (UC). In patients with CD, endoscopic remission was attained in 51 (52%) of the patients on adalimumab, 38 (53%) of the patients on infliximab, 34 (56%) of the patients on ustekinumab, and 16 (51%) of the patients on vedolizumab. In patients with UC, endoscopic remission was attained in 40 (56%) of the patients on infliximab, 26 (61%) of the patients on adalimumab, 8 (55%) of the patients on ustekinumab, and 11 (53%) of the patients on vedolizumab. Conclusion: adalimumab, infliximab, ustekinumab, and vedolizumab were all effective in achieving clinical and endoscopic clinical outcomes in IBD in both UC and CD. The findings of this study suggest that the efficacy of biologics in a Middle Eastern population is similar to that in a Western population. [ABSTRACT FROM AUTHOR]

Current therapeutic strategies for inflammatory bowel disease (IBD) have reached a plateau in the rates of response and/or remission achieved with a single therapeutic agent. Consequently, the advanced combination therapy (ACT) strategy has emerged as a novel treatment concept for IBD. ACT involves the use of two different targeted therapies, whether biologic or small molecules, with the primary goal of overcoming the therapeutic plateau. Real-world evidence is accumulating among patients undergoing ACT, especially those dealing with concurrent IBD and extraintestinal manifestations or grappling with medically refractory IBD. The recently conducted VEGA study, a randomized clinical trial, has provided crucial insights by demonstrating that the short-term combination of dual biological agents can lead to superior disease control compared to single agents in patients diagnosed with ulcerative colitis (UC). This suggests that ACT holds promise as a therapeutic option to enhance disease control effectively. However, there is still limited evidence of ACT in UC patients who have proven refractory to biologic therapy and patients with Crohn's disease. This review aims to discuss whether ACT represents the optimal approach for overcoming the therapeutic ceiling in IBD. [ABSTRACT FROM AUTHOR]

Allogeneic platelet-rich plasma (al-PRP) is gaining attention in clinical practice for treating chronic refractory wounds, though research results remain controversial. To assess the clinical efficacy of al-PRP for chronic refractory wounds. Databases including PubMed, Cochrane Library, Embase, CNKI, SinoMed, VIP, and WFPD were searched for randomized controlled trials comparing al-PRP with conventional treatments up to October 2023. Two researchers independently screened studies, extracted data, and assessed quality. Statistical analysis was conducted using RevMan 5.4, and potential publication bias was assessed and corrected using funnel plots and Egger's test. Twelve studies with 717 cases were included. Meta-analysis showed al-PRP significantly improved outcomes compared to non-al-PRP treatments: increased healing rate (RR 2.72, 95% CI 1.77–4.19, p < 0.00001), shortened healing time (SMD − 1.03, 95% CI -1.31 to -0.75, p < 0.00001), improved efficacy rate (RR 1.19, 95% CI 1.10–1.28, p < 0.00001), increased wound shrinkage (MD 35.65%, 95% CI 21.65–49.64, p < 0.00001), and reduced hospital stays (MD -2.62, 95% CI -4.35 to -0.90, p = 0.003). Al-PRP is a feasible, effective, and safe biological therapy for chronic refractory wounds. Trial registration: PROSPERO Identifier CRD42022374920. [ABSTRACT FROM AUTHOR]

Background: Patients with asthma with an eosinophilic phenotype may be eligible for additional treatment options to improve disease control; however, the prevalence and frequency of eosinophil testing is unknown. This study assessed blood eosinophil count testing prevalence in patients with asthma by exacerbation frequency and healthcare provider (HCP) type. Methods: This was a retrospective, longitudinal, real-world study (GSK ID: 214470) utilizing the Merative Explorys® Universe electronic health records database. Eligible patients had ≥ 2 asthma diagnostic codes (January 2016–December 2018) (Index date: first asthma diagnosis). Outcomes included patient demographics and clinical characteristics (12 months pre-index [baseline]), and prevalence of blood eosinophil count testing, stratified by exacerbation frequency (infrequent exacerbations [< 2]) or frequent exacerbations [≥ 2] or primary HCP (Allergist/Pulmonologist, a primary care physician [PCP] or other HCP) during the 12 months post-index (follow-up). Results: Of 400,254 patients included (mean age: 51.2 years; 70.8% female), the most common provider type at baseline was a PCP (76.8%). A higher proportion of patients with frequent exacerbations had blood eosinophil count tests at baseline (55.4–69.5%) and follow-up (67.9–75.1%), compared with patients with infrequent exacerbations (55.5–63.7%, 62.4–67.3%). Significantly more patients in the Allergist/Pulmonologist subgroup had ≥ 1 blood eosinophil count test result compared with patients in the PCP subgroup at both baseline (59.9% vs. 50.7%; p < 0.001) and follow-up (59.0% vs. 56.2%; p < 0.001). In the total population, the mean (SD) number of tests ordered was 3.4 (5.3) and 4.1 (6.4) during the baseline and follow-up periods, respectively. A greater mean number of tests were ordered for patients with frequent exacerbations, most apparently in the Allergist/Pulmonologist subgroup during baseline and follow-up (7.4 vs. 4.9). For patients with frequent exacerbations and blood eosinophil count test results, the mean (SD) number of tests ranged from 3.1 (4.6) to 5.8 (8.3) at baseline and 5.1 (8.5) to 7.4 (10.6) during follow-up. Conclusions: The prevalence of blood eosinophil count testing in patients with asthma remains suboptimal. Routine blood eosinophil count testing should be considered by HCPs for patients with asthma to increase identification of the eosinophilic asthma phenotype, which may inform the decision to advance to targeted biologic therapy. [ABSTRACT FROM AUTHOR]

Background: Pegfilgrastim is a long-acting recombinant human granulocyte colony-stimulating factor biologic that is indicated to reduce the incidence of infections, manifested by febrile neutropenia, in patients receiving myelosuppressive anti-cancer drugs and to increase survival in patients acutely exposed to myelosuppressive doses of radiation. Due to the high cost of biologic therapy and the scarcity of biosimilar alternatives, there is an unmet medical need for targeted biologics. Objective: This comparative analytical investigation aimed to confirm the similarity of biosimilar Stimufend® (pegfilgrastim-fpgk) to reference product Neulasta® (pegfilgrastim). Methods: The analysis was designed using state-of-the-art orthogonal techniques and side-by-side testing to compare the physicochemical and biological properties of these two products. The measured quality attributes included the primary structure and higher order structure of the molecule, purity/impurity profiles, product variants, process-related impurities, composition, content, and biological activity. The statistical analysis was based on risk ranking of the critical quality attributes (very low, low, moderate, high, very high), and scientific considerations in combination with the characteristics of the assay (sensitivity, selectivity, and variability). In addition, non-quantitative parameters were compared using a descriptive assessment of the product profile. Analytical similarity was concluded by quality attributes falling within the defined range of the originator product. Results: The results of this study confirm that Stimufend® is biosimilar to Neulasta® for all measured quality attributes. There are no clinically significant differences between Stimufend® and Neulasta®, which was confirmed by the marketing approval for Stimufend® by the Food and Drug Administration and the European Medicines Agency. Conclusion: The findings of this study provide robust evidence supporting the structural and functional biosimilarity between Stimufend® and Neulasta®. [ABSTRACT FROM AUTHOR]

In the present review, we focused on recent translational and clinical discoveries in asthma immunology, facilitating phenotyping and stratified or personalized interventions for patients with this condition. The immune processes behind chronic inflammation in asthma exhibit marked heterogeneity, with diverse phenotypes defining discernible features and endotypes illuminating the underlying molecular mechanisms. In particular, two primary endotypes of asthma have been identified: "type 2-high," characterized by increased eosinophil levels in the airways and sputum of patients, and "type 2-low," distinguished by increased neutrophils or a pauci-granulocytic profile. Our review encompasses significant advances in both innate and adaptive immunities, with emphasis on the key cellular and molecular mediators, and delves into innovative biological and targeted therapies for all the asthma endotypes. Recognizing that the immunopathology of asthma is dynamic and continuous, exhibiting spatial and temporal variabilities, is the central theme of this review. This complexity is underscored through the innumerable interactions involved, rather than being driven by a single predominant factor. Integrated efforts to improve our understanding of the pathophysiological characteristics of asthma indicate a trend toward an approach based on disease biology, encompassing the combined examination of the clinical, cellular, and molecular dimensions of the disease to more accurately correlate clinical traits with specific disease mechanisms. [ABSTRACT FROM AUTHOR]

Background: We aimed to study the impact of biological therapies in Saudi Arabia on patients with severe asthma (SA) combined with chronic rhinosinusitis (CRS) in terms of clinical outcomes. Methods: This is a retrospective observational cohort research that was undertaken at the severe asthma clinics of the Armed Forces Hospital of the Southern Region (AFHSR) and King Khalid University Hospital, Abha, from March to September 2022 to delineate the effects of 3 biological therapies (dupilumab, benralizumab, and omalizumab) in adults with SA and concomitant CRS. Clinical outcomes assessed included asthma exacerbation frequency, hospitalization rates, use of oral corticosteroids (OCs), and the asthma control test (ACT) scores before and 1 year after biological therapies. Results: Eighty patients were enrolled, with a mean age of 46.68. There were 45 (56%) females and 35 (44%) males. There was a notifiable decrease in the frequency of exacerbations and hospitalization and in the number of patients who received OCs after 6 and 12 months of biological therapies compared to pre-biological therapies, respectively (p < 0.001 each), while there was a significant increase in the ACT scores at 6 and 12 months post-biological therapies, compared to pre-biological therapies, respectively (p < 0.001). These significant differences were maintained with all the 3 biologics used. Conclusions: Results from the first study from two large Saudi Arabian tertiary centers for patients with SA and CRS agree with and support those of worldwide real-life ones. One-year follow-up showed the effectiveness of the 3 drugs in terms of reduced frequency of asthma hospitalizations and exacerbations, the use of OCs, and improved ACT scores. Further prospective multicenter studies are warranted. [ABSTRACT FROM AUTHOR]

Background: The therapeutic landscape for ulcerative colitis (UC) has recently broadened to include anti-TNFα, anti-integrin, and anti-IL-12/23p40 antibody agents. These biological agents are tailored to individual patient profiles. However, some patients cease biological treatment. This study investigates factors influencing the discontinuation of biological treatment in UC patients. Methods: This retrospective single-cohort study encompasses UC patients who commenced treatment with biological agents like infliximab, adalimumab, golimumab, vedolizumab, and ustekinumab from April 2019 to March 2022. Patients were categorized into continuation and discontinuation groups based on their one-year treatment status. Baseline characteristics were compared between the groups. Results: Of the 116 UC patients, 102 were included in the study. Among these, 74 (72.5%) continued and 28 (27.5%) discontinued biological therapy. Discontinuation rates for infliximab, adalimumab, golimumab, vedolizumab, and ustekinumab were 33.3%, 25.0%, 50.0%, 30.2%, and 15.6%, respectively. The primary discontinuation reason was lack of efficacy (85.7%), followed by adverse events (7.1%), pregnancy (3.6%), and death (3.6%). The discontinuation group had a significantly lower rate of concomitant thiopurine compared to the continuation group (28.6% vs. 56.8%, p = 0.0132). Multivariable analysis revealed that concomitant thiopurine was independently associated with therapy continuation (p = 0.0075). Conclusion: The study indicates that concomitant thiopurine significantly correlates with the continuation of biological therapies in UC patients, underscoring the importance of concomitant thiopurine in sustaining biological therapy. Further studies are warranted to assess the efficacy of combination therapy. [ABSTRACT FROM AUTHOR]

Simple Summary: The landscape for medical therapy in head and neck squamous cell carcinoma has considerably evolved in the last few decades. While early-stage disease remains primarily managed with surgery and/or radiation therapy, immunotherapy and antibody-based therapy have been transformative and practice-changing for patients with recurrent and/or metastatic disease. Unfortunately, many patients ultimately develop resistance to these approaches, with limited options for subsequent treatment. A wide breadth of novel therapies has shown promise in preclinical and early-phase clinical settings, many of which are now undergoing translation into the clinical arena. Here, we provide a review of how medical therapy is used in the management of HNSCC, with a specific focus on active clinical trials, to inform the medical oncologist treating patients with this disease. Head and neck squamous cell carcinoma (HNSCC) is a complex cancer requiring a multidisciplinary approach. For patients with locally or regionally advanced disease, surgery and/or radiation are the cornerstones of definitive treatment. Medical therapy plays an important adjunct role in this setting, typically consisting of a platinum-based regimen given as induction, concurrent, or adjuvant treatment. While relapsed/metastatic HNSCC has historically been a difficult-to-treat disease with poor outcomes, options have considerably improved with the incorporation of biologics and immune checkpoint inhibitors. Clinical trials are ongoing to investigate novel approaches, including new and combination immunotherapies, targeted therapies, therapeutic vaccines, antibody–drug conjugates, and cellular therapies. The results thus far have been mixed, highlighting the knowledge gaps that continue to challenge the medical oncologist treating HNSCC. Here, we present the most updated and broad review of the current treatment landscape in both locoregional and metastatic HNSCC and discuss the expansive future medical therapies under investigation. [ABSTRACT FROM AUTHOR]

Background/Objectives: With the increasing prevalence of Crohn's disease (CD), treatment options for patients who fail conventional and advanced therapy are highly needed. Therefore, we explored the safety and efficacy of extracorporeal photopheresis (ECP) using 5-aminolevulinic acid (ALA) and blue light (405 nm). Methods: Patients with active CD who failed or were intolerant to biological therapy were eligible. Mononuclear cells (90 mL) were collected from each patient using a Spectra Optia® apheresis system and diluted with 100 mL of 0.9% sodium chloride in a collection bag. The cells were incubated with ALA at a concentration of 3 millimolar (mM) for 60 min ex vivo and illumination with an LED blue light (405 nm) source (BLUE-PIT®) before reinfusion to the patient. Recording of vital signs and adverse events were regularly performed. At week 13, we assessed the patients with colonoscopy, the Harvey Bradshaw Index (HBI), the Inflammatory Bowel disease Health Related Quality of Life Questionnaire, and the measurement of serum C-reactive protein and fecal calprotectin (FC) levels. Biopsies of the intestines were taken for immunohistochemistry. Results: Seven patients were included. Four patients completed the treatments, with a total of 24 treatments. Three of the four patients achieved a favorable response, including a lower HBI, lower FC levels, and/or endoscopic improvement. No significant adverse events were observed. The remaining three patients received only one, three, or five treatments due to technical difficulties, medical reasons, or the withdrawal of informed consent. Conclusions: ALA-based ECP appears safe and seems to give some clinical improvement for the patients with active CD who failed to respond to conventional and advanced therapies. [ABSTRACT FROM AUTHOR]

Introduction Methods Results Conclusions Therapeutic burden (TB) has been identified as a potential predictor of response to biologic therapy in hidradenitis suppurativa (HS). We aim to analyze the determinants of TB in real‐world clinical settings among HS patients to explain this concept and its utility as an additional tool for guiding therapeutic decision‐making.We conducted a cross‐sectional study including all consecutive HS patients attending a specialized HS clinic between 2017 and 2024. The primary variable was TB, defined as the cumulative sum of prior systemic treatment cycles and surgical interventions for HS. We analyzed whether sociodemographic or clinical factors were associated with a higher TB.We included 557 HS patients. Of these, 50.81% were women, and the mean age was 41.87 (14.19) years. Most patients (62.30%) were referred from general dermatology consultations. The mean disease duration was 17.52 (11.51) years. Regarding disease severity, 46.50% presented with Hurley II, and 42.19% had an IHS‐4 score between 4 and 10. Before their baseline visit, 9.70% of patients had received biological therapy, mostly adalimumab (88.89%). The mean TB was 2.42 (2.25) systemic medical and/or surgical interventions. Referral from general dermatology or other hospital departments, older age, longer disease duration, greater HS severity, presence of pilonidal sinus, and prior biological therapy were significantly associated with higher TB.Our findings suggest that TB comprehensively captures HS severity and progression factors. This metric could prove valuable in aiding decision‐making for HS patients by indicating when a change in therapy might be necessary. [ABSTRACT FROM AUTHOR]

Targeted biologic drugs and small molecules have transformed the psoriasis treatment landscape in recent years. The Belgian healthcare system, in common with many others across Europe, must balance the burgeoning use of these transformative, yet expensive, drugs with the sustainable use of limited resources. Drawing on recent updates to the EuroGuiDerm and the German S2 psoriasis guidelines, eight Belgian dermatologists experienced in treating patients with psoriasis undertook a quasi‐Delphi initiative to provide perspectives on the current opportunities and challenges in psoriasis. This update focuses on responsible ways to rationalize the use of innovative treatments (e.g. biologics and small molecules). Inherently, this required viewpoints on the International Psoriasis Council's new definition of severe psoriasis, defining psoriasis severity and the concept of treating to target. It discusses the appropriateness of using older biologics classes, biosimilars and personalized dosing and lastly, how teledermatology may play a role in providing sustainable, patient‐centric psoriasis care. In addition, this manuscript includes the updated Belgian evidence‐based treatment advice in psoriasis (BETA‐PSO) to reflect recent data and drug approvals. The recommendations reflect the best practices for clinicians when using systemic and biologic therapies to treat patients with psoriasis and offer guidance on how they may prescribe these drugs sustainably and efficiently. [ABSTRACT FROM AUTHOR]

Intruduction and purpose: Patients with severe asthma account for approximately 3% to 10% of all asthma patients. They have higher hospital utilization rates and treatment costs than patients with non-severe asthma. Previously, treatment options for these patients were limited due to unacceptable side effects. However, the advent of biologic therapies has provided promising targeted therapy for these patients. State of knowledge: Biologic therapies target inflammatory modulators that play a key role in the pathogenesis of asthma, particularly in patients with high T2 cells. These therapies have shown promising results in reducing asthma symptoms, improving lung function, decreasing the use of oral corticosteroids, and enhancing patients' quality of life. Conclusions: This article reviews the mechanism of action, efficacy, and indications of currently approved biologic drugs available in Poland, as well as potential therapeutic targets for the future. [ABSTRACT FROM AUTHOR]

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by abdominal pain, diarrhea, rectal bleeding, and weight loss. The pathogenesis and treatment of UC remain key areas of research interest. Various factors, including genetic predisposition, immune dysregulation, and alterations in the gut microbiota, are believed to contribute to the pathogenesis of UC. Current treatments for UC include 5-aminosalicylic acids, corticosteroids, immunosuppressants, and biologics. However, study reported that the one-year clinical remission rate is only around 40%. It is necessary to prompt the exploration of new treatment modalities. Biologic therapies, such as anti-TNF-α monoclonal antibody and JAK inhibitor, primarily consist of small molecules targeting specific pathways, effectively inducing and maintaining remission. Given the significant role of the gut microbiota, research into intestinal microecologics, such as probiotics and prebiotics, and fecal microbiota transplantation (FMT) shows promising potential in UC treatment. Additionally, medicinal herbs, such as chili pepper and turmeric, used in complementary therapy have shown promising results in UC management. This article reviews recent findings on the mechanisms of UC, including genetic susceptibility, immune cell dynamics and cytokine regulation, and gut microbiota alterations. It also discusses current applications of biologic therapy, herbal therapy, microecologics, and FMT, along with their prospects and challenges. [ABSTRACT FROM AUTHOR]

ABSTRACT Background Methods Results Conclusions There are limited surrogate biomarkers to identify the active inflammatory pathway in psoriasis to direct treatment with targeted biologic therapies. We investigated the association of interleukin (IL)‐36 epidermal expression, a diagnostic marker of psoriasis, with response to biologic therapy in patients with psoriasis.Retrospective immunohistochemical and chart review pilot study.Patients with psoriasis with low (scores 0–2) vs. high (scores 3–4) IL‐36 expression did not have significantly different response rates to tumor necrosis factor α (TNFα), IL‐17, and IL‐12/23 or IL‐23 inhibitors; and similarly, mean IL‐36 expression scores did not significantly differ among responders vs. non‐responders to each treatment mechanism. However, in patients with psoriasis treated with IL‐12/23 or IL‐23 inhibitors, there was a marked absolute difference in response rates in those with high vs. low IL‐36 (84% vs. 50%, p = 0.12) and in mean IL‐36 scores in responders vs. non‐responders (3.35 vs. 2.57, p = 0.19).Patients with psoriasis with high IL‐36 expression were more likely to respond to IL‐12/23 and IL‐23 inhibition than those with low IL‐36, though these findings were not statistically significant. Additional studies with larger sample sizes are needed to validate and expand upon these findings. [ABSTRACT FROM AUTHOR]

ABSTRACT Allergic asthma is the predominant phenotype among asthmatics. Although conventional pharmacotherapy is a central component in the management of asthma, it does not enable control of asthma symptoms in all patients. In recent decades, some uncontrolled asthmatic patients, especially those with allergic asthma, have benefited from biological therapies. However, biologics do not address all the unmet needs left by conventional pharmacotherapy. Furthermore, it is noteworthy that neither conventional pharmacotherapy nor biological therapies have disease‐modifying properties. In this context, allergen immunotherapy (AIT) represents an indispensable component of the therapeutic arsenal against allergic asthma, due to its disease‐modifying immunological effects. In this review article, funded by an AIT manufacturer, we find clinical trials support AIT as the only treatment option able both to improve allergic asthma symptoms and to prevent the onset and worsening of the condition. For patients with severe asthma or other safety concerns, the combination of AIT and biologics offers very promising new treatment modalities for the management of allergic asthma.Trial Registration: clinicaltrials.gov identifier: NCT06027073 [ABSTRACT FROM AUTHOR]

Background: Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by inflammatory lesions, often leading to scarring. Managing HS can be difficult, requiring biological therapy, specifically adalimumab. Methods: A retrospective study was conducted on patients diagnosed with HS and treated with the TNF-α inhibitor adalimumab. Data from 21 patients were included in this study. International Hidradenitis Suppurativa Severity Score System (IHS4); Dermatology Life Quality Index (DLQI); pain intensity according to the Visual Analogue Scale (VAS); and number of nodules, abscesses, and fistulas were assessed. Results: Notably, 47.62% of patients achieved Hidradenitis Suppurativa Clinical Response. The mean number of inflamed nodules decreased from 5.62 ± 4.12 to 3 ± 3.46, abscesses decreased from 1.76 ± 2.63 to 0.81 ± 1.4, and fistulas decreased from 2.62 ± 1.86 to 2 ± 1.9 (p < 0.05). The IHS4 score decreased from 19 ± 10.78 to 12.62 ± 11.13 (p = 0.001), DLQI from 15.76 ± 7.73 to 7.43 ± 7.76 (p < 0.001), and VAS from 6.69 ± 1.56 to 3.64 ± 2.65 (p < 0.001). There was a significant difference in the baseline IHS4 scores between patients who had prior surgery with a mean score of 23.86 ± 9.4 versus non-surgical patients with a mean IHS4 score of 9.29 ± 5.53 (p = 0.001). Conclusions: About half of HS patients responded positively to adalimumab treatment; the use of the drug reduces inflammatory lesions, and pain, and improves quality of life. [ABSTRACT FROM AUTHOR]

Background: Few studies have compared the efficacy and safety of second-line biological therapies in ulcerative colitis (UC) patients with prior exposure to anti-tumor necrosis factor (TNF) therapy. We aim to compare the efficacy and safety between ustekinumab, vedolizumab, and tofacitinib, a current option as second-line biological therapy with different mechanisms in those patients. Methods: This retrospective multi-center study was conducted across five institutions from 2011 to 2022. We enrolled patients with moderate to severe UC who failed anti-TNF therapy and subsequently received ustekinumab, vedolizumab, or tofacitinib as second-line biological therapy. The outcomes were analyzed for clinical response/remission and endoscopic improvement/remission rates after induction therapy, drug persistency, and adverse events. Results: A total of 70 UC patients were included and grouped into ustekinumab (11 patients), vedolizumab (40 patients), and tofacitinib (19 patients) treatments. The clinical response/remission rates after induction therapy were similar between ustekinumab (90.9/81.8%), vedolizumab (92.5/65.0%), and tofacitinib (94.7/73.7%). There were no significant differences in the endoscopic improvement/remission rates between the three groups: 90.9/18.2% for ustekinumab, 72.5/12.5% for vedolizumab, and 84.2/26.3% for tofacitinib. Drug persistence was similar across the three agents (p = 0.130). Three patients of the tofacitinib group experienced adverse events (herpes zoster and hypertriglyceridemia). Conclusions: Based on real-world data, second-line biological therapy with ustekinumab, vedolizumab, and tofacitinib showed comparable efficacy in patients with moderate to severe UC with prior exposure to anti-TNF therapy. [ABSTRACT FROM AUTHOR]

Introduction: The aims of study are to estimate the indirect costs and intangible costs of RA in Morocco and to identify the factors likely to influence these costs among suffering patients. Methods: In the current study, data were collected by face‐to‐face interviews using a questionnaire in addition to the patient's files. Indirect costs including productivity losses and formal care, and intangible costs such as the cessation of physical and leisure activities, family care and divorce or remaining single until menopause's age for women due to the disease were reported for 110 RA patients. Results: The results show that among patients who lost totally or partially their salary, the annual average costs is $2337.73 ± 1649.80 per patient, with a minimum and a maximum of $600 and $9630 respectively. As regards formal care, only 13 patients reported that they paid for care services; the annual average cost was $421.84 ± 261.34 with a minimum of $252 and a maximum of $1200. Statistical analysis revealed significant differences between annual lost salary and gender (p =.04) disease duration (p =.016) and sport/leisure activities cessation (p =.08). Conclusion: Besides the burden in terms of productivity loss and caregivers' costs, the intangible costs are considerable, especially those related to divorce and spinsterhood. These conclusions may contribute to the understanding of the socio‐economic impact of the disease and to the development of strategies for better governance of RA in Morocco. [ABSTRACT FROM AUTHOR]

Background: Biologics are among the most effective therapies for psoriasis. However, many patients are only introduced to them at advanced stages of the disease course. Objectives: Our aim was to identify predictors of initiating biologic therapy in patients with psoriasis and compare patients initiating biologics early versus late in their disease course. Methods: Kaplan–Meier curves visualized time to biologic initiation, while Cox regression models further explored variables as predictors of biologic initiation. Mann–Whitney U and chi‐squared tests compared patients who started biologics early with those who began biologics later in the disease course. Results: Our primary analysis included 233 psoriasis patients. Cox regression showed that age at diagnosis (P = 0.007), general physical well‐being (P = 0.02), and nail psoriasis severity (P = 0.02) were significantly associated with time to biologic initiation. Our secondary analysis, the comparisons between patients starting biologics early versus later in the disease course, included a total of 378 patients. The median (interquartile range [IQR]) age at diagnosis was 34.5 (25.0–51.2) years for patients initiating biologics within 5 years, compared to 22.0 (15.0–32.8) years for patients initiating biologics later (P < 0.0001). The median (IQR) age at initiation was 37.0 (27.0–53.2) and 45.0 (36.0–55.0) years for patients initiating biologics earlier versus later than 5 years (P = 0.04). Conclusions: Age at diagnosis, general well‐being, and severity of nail psoriasis significantly predicted future initiation of biologic treatment. Patients initiating biologics early in their disease course were generally older at diagnosis but younger at the time of biologic initiation compared to patients initiating biologics later in their disease course. [ABSTRACT FROM AUTHOR]

The article discusses the real-world effectiveness and drug survival of guselkumab over a 3-year period in treating moderate-to-severe plaque psoriasis, including difficult-to-treat areas. Guselkumab, an anti-IL23 biologic, has shown superior efficacy compared to adalimumab in clinical trials, with sustained high levels of clinical response over 5 years of treatment. Real-life studies have confirmed the effectiveness and safety of guselkumab, particularly in difficult-to-treat areas like scalp, palmoplantar, and genital psoriasis. The study emphasizes the importance of being treatment-naive for achieving complete or almost complete clinical clearance at Week 52. [Extracted from the article]

Psoriasis is a chronic, relapsing inflammatory skin disorder that is associated with substantial physical and psychosocial comorbidity. Although biologic agents have offered transformative therapeutic advantages to those unresponsive to traditional treatments, data from recent literature indicate significant undertreatment of certain populations, highlighting potential barriers to access. This review aims to comprehensively elucidate barriers to biological therapy, addressing a recognized gap in the current literature. A search was conducted using MEDLINE, Embase, and Web of Science to investigate the obstacles and disparities that prevent access to biologic treatments in biologic‐naïve psoriatic patients. Emergent themes were then systematically categorized into five primary domains: patient‐level, prescriber‐level, medicine‐level, organizational‐, and external environment‐level factors. Our results demonstrate pronounced barriers and disparities encompassing increased age, race, socioeconomic status, rural location, cost and insurance, and insufficient knowledge that may hinder access to biologic treatments among psoriatic patients. Further research on how these barriers can be effectively addressed is needed to optimize treatment outcomes. [ABSTRACT FROM AUTHOR]

Background: Psoriasis is a chronic inflammatory skin disorder with significant impact on quality of life. The evolving landscape of treatment modalities includes traditional therapies and newer biologic agents. This study systematically reviews the efficacy and safety of various psoriasis treatments to guide clinical decision-making. Methods: A comprehensive literature search was conducted across PubMed, Embase, Cochrane Library, and ClinicalTrials.gov, yielding 45 studies that met the inclusion criteria. These studies were categorized into four treatment groups: topical, phototherapy, systemic, and biologic therapies. Data on efficacy, measured by PASI score reduction, and safety were extracted and analyzed. Results: Biologic therapies targeting TNF-α, IL-12/23, and IL-17 demonstrated the highest efficacy with mean PASI reductions of 75%, 72%, and 78%, respectively. Systemic therapies such as methotrexate and cyclosporine showed mean PASI reductions of 65% and 70%. Topical treatments and phototherapy also proved effective but were less impactful compared to biologics. Safety profiles varied, with biologics associated with increased risk of infections and injection site reactions, while systemic therapies had notable risks of organ toxicity. Conclusion: Biologic therapies represent a significant advancement in psoriasis management, offering superior efficacy for moderate to severe cases. However, their high cost and potential side effects highlight the need for personalized treatment approaches. Traditional therapies remain valuable, particularly for milder forms or as adjunctive treatments. Future research should focus on long-term safety and efficacy, and strategies to optimize treatment outcomes. [ABSTRACT FROM AUTHOR]

The incidence of metabolic syndrome is rising worldwide, and an estimated 40% of adults are affected by the condition. Metabolic syndrome is a cluster of connected cardiometabolic conditions including obesity, impaired fasting glucose, hypertension, decreased levels of high-density lipoprotein cholesterol, and elevated serum triglycerides. Metabolic syndrome increases the long-term risk of both type 2 diabetes mellitus and cardiovascular disease. This condition is driven by insulin resistance and generally results from a combination of overnutrition and sedentary lifestyle, which serve to increase adiposity and cause metabolic abnormalities. As such, lifestyle change forms the foundation of metabolic syndrome treatment. This article reviews diet and exercise interventions that form this foundation, along with natural substances that have evidence of benefit in people with metabolic syndrome, including curcumin, melatonin, vitamin D, berberine, and fish oil. [ABSTRACT FROM AUTHOR]

Supramolecular structures are widespread in living system, which are usually spatiotemporally regulated by sophisticated metabolic processes to enable vital biological functions. Inspired by living system, tremendous efforts have been made to realize spatiotemporal control over the self‐assembly of supramolecular materials in synthetic scenario by coupling chemical reaction with molecular self‐assembly process. In this review, we focused on the works related to supramolecular hydrogels that are regulated in space and time using chemical reaction. Firstly, we summarized how spatially controlled self‐assembly of supramolecular hydrogels can be achieved via chemical reaction‐instructed self‐assembly, and the application of such a self‐assembly methodology in biotherapy was discussed as well. Second, we reviewed dynamic supramolecular hydrogels dictated by chemical reaction networks that can evolve their structures and properties against time. Third, we discussed the recent progresses in the control of the self‐assembly of supramolecular hydrogels in both space and time though a reaction‐diffusion‐coupled self‐assembly approach. Finally, we provided a perspective on the further development of spatiotemporally controlled supramolecular hydrogels using chemical reaction in the future. [ABSTRACT FROM AUTHOR]

This correction notice is for an article titled "Certolizumab Pegol for the Treatment of Plaque Psoriasis in Routine Clinical Practice: One-Year Results from the CIMREAL Study" published in Dermatology & Therapy. The correction replaces incorrect versions of Tables 1 and 2 with the correct versions. Table 1 provides information on demographics, baseline, and clinical characteristics of the study participants, while Table 2 presents an overview of adverse events. The original article has been corrected. [Extracted from the article]

Factors such as obesity, alcohol consumption, and tobacco use are associated with both increased psoriasis severity and inadequate response to systemic and biologic therapies. Obesity is linked to chronic inflammation, which can contribute to psoriasis pathogenesis. Fixed-dose therapies may have reduced efficacy in patients with a higher body mass index, while weight-based dosing can increase the burden of drug-specific side effects. Alcohol and nicotine from tobacco have also been shown to stimulate keratinocyte and immune cell proliferation and production of proinflammatory cytokines. While these risk factors are prevalent among patients with moderate-to-severe psoriasis, their influence on treatment outcomes may be overlooked when evaluating therapeutic options. Brodalumab is a fully human interleukin-17 receptor A antagonist approved for the treatment of moderate-to-severe psoriasis. In this review, we describe the lifestyle-related risk factors associated with decreased response to treatment. We further summarize the post hoc analyses of brodalumab in participant subgroups with moderate-to-severe psoriasis and a history of prior biologic failure, obesity, and alcohol or tobacco use from two phase 3 clinical trials (AMAGINE-2 and AMAGINE-3; ClinicalTrials.gov identifiers: NCT01708603 and NCT01708629, respectively). Our review of clinical trial and real-world data suggests that brodalumab is an efficacious and safe treatment option for patients with lifestyle factors that increase the likelihood of treatment failure, allowing them to achieve skin clearance and improve quality of life. [ABSTRACT FROM AUTHOR]

Introduction: Due to variable psoriasis symptoms, disease progression, and individual responses to therapy, patients may start, stop, or switch biologic therapies. Real-world data on the associated disease burden of patients with psoriasis who do and do not switch biologics are incomplete. Methods: This study compared disease burden among patients from the CorEvitas Psoriasis Registry (July 2017–December 2021) who switched biologics and those who did not within 4–12 months following initiation. Disease-related patient-reported outcomes (PROs) were recorded, including skin pain, itching, activity impairment, and effects on health-related quality of life (HRQoL). Disease severity was measured by body surface area (BSA) and Psoriasis Area and Severity Index (PASI). Unadjusted and adjusted regression models were used to compare study outcome measures between the two groups. Results: This study included 2145 patients, with 159 classified as switchers and 1986 as non-switchers. The most common reason for switching therapy was failure to maintain initial response (51.7%; n = 78). Moderate-to-severe disease (BSA ≥ 3) was found among 83.0% (n = 132) of switchers versus 26.1% (n = 516) of non-switchers. PASI > 5 was reported among 49.7% (n = 79) of switchers versus 8.6% (n = 171) of non-switchers. Differences in skin pain, itching, and effects on HRQoL between switchers and non-switchers were larger in magnitude for bio-experienced patients. Conclusions: Patients who switched biologic therapy experienced a greater disease burden of psoriasis across PROs than non-switchers. Patient-centered factors may be important drivers of biologic switching. Our findings suggest the association between switching and disease burden may be stronger among patients with prior biologic therapy experience. Plain Language Summary: Patients with psoriasis often need treatment over a long period of time. Common treatments include biologic medications, which help to reduce inflammation. Different patients may experience different psoriasis symptoms, and these symptoms can lead to changes in biologic over time. It is important that we understand how psoriasis severity and patients' day-to-day well-being affect switching of psoriasis biologic medications. In this study, we used information from a database of patients with psoriasis. The database includes information on patients' psoriasis-related medication history, including whether they change their medication. We looked at data from patients who switched and patients who did not switch their biologic medication, and examined differences in their skin pain, itching, tiredness, difficulty participating in normal activities, and effects on day-to-day well-being. Patterns between these two groups were also studied on the basis of whether patients had used biologic medications before or whether they had a related condition, called psoriatic arthritis, in addition to psoriasis. Overall, we found that patients who changed their biologic medication had experienced more difficult psoriasis symptoms than those who had not changed their medication, such as itching and skin pain. These symptoms had a greater impact on switching biologic medication in patients who had used a biologic medication before than for those who were using their first biologic medication. [ABSTRACT FROM AUTHOR]

Introduction: Patients with psoriasis (PSO) and psoriatic arthritis (PsA) may frequently switch biologic therapies over the course of treatment because of symptom variability and individual responses. Real-world studies analyzing patient characteristics and clinical factors associated with biologic switching are limited. Methods: This longitudinal cohort study used real-world data from the CorEvitas Psoriasis Registry to evaluate the relationship between associated disease factors and biologic switching among patients with PSO and PsA in the United States (US) and Canada following initiation of a biologic. Patients were evaluated between April 2015–August 2022. Combinations of disease severity (as measured by Psoriasis Area Severity Index [PASI]) and Dermatology Life Quality Index (DLQI) as a measure of health-related quality of life (HRQoL) were assessed, and the association with time to switching was calculated using Cox proportional hazards regression modeling. Results: Among 2580 patient-initiations (instances of patients initiating a biologic), 504 (19.5%) switched biologics within 30 months of initiation. Switching was more frequent when either PASI > 10 or DLQI > 5 compared with PASI ≤ 10 or DLQI ≤ 5 at follow-up. Patients with higher skin involvement (PASI > 10) and impact on HRQoL (DLQI > 5) were 14 times more likely to switch (hazard ratio = 14.2, 95% confidence interval: 10.7, 18.9) than those with lower skin involvement (PASI ≤ 10) and HRQoL (DLQI ≤ 5). Conclusions: Patients with PSO and PsA treated in a real-world dermatology setting with substantial disease factors following biologic initiation were more likely to switch therapies. Those with PASI > 10 and DLQI > 5 switched more frequently than those with PASI ≤ 10 and DLQI ≤ 5. Plain Language Summary: Many patients with psoriasis may also have a related condition called psoriatic arthritis. Biologic medications work by helping to reduce inflammation and are commonly used to treat the symptoms of psoriasis and psoriatic arthritis. Patients might not all respond the same way to treatment and may need to change their medications over time. It is important we understand the reasons for switching medications to help patients better manage their symptoms. This study used information from a database on patients with both psoriasis and psoriatic arthritis. The database includes information on patients' medical history, including when they start and change their medication. We looked at data from patients who switched medications and patients who did not switch medications and examined differences in both how serious a doctor found their disease and the patients' own opinions of their overall health. We found that patients were more likely to change their biologic medication if they had more difficult psoriasis and psoriatic arthritis symptoms that caused worse skin problems, joint pain, and effects on their overall health compared with patients who had not changed their medication. These results suggest that it is important to consider both how serious a doctor finds their disease and patients' opinions of how much their symptoms affect their overall health. Understanding the reasons why patients switch medications will help to develop better ways of managing psoriasis and psoriatic arthritis. [ABSTRACT FROM AUTHOR]

Background: Severe asthma is a challenging condition that often resists traditional treatments and requires high-dose inhaled corticosteroids and other controllers to manage uncontrolled symptoms. Recent advances include the use of biologic agents targeting specific inflammation pathways, which have improved symptom control and quality of life, although their effects on small airways remain less understood. Methods: This prospective observational study, conducted at Tor Vergata University Hospital in Rome from July 2021 to March 2024, aims to evaluate the efficacy of treatments in patients with uncontrolled severe asthma. It involves baseline assessments and follow-ups at 1 and 3 months post-biological therapy initiation, focusing on both spirometric and non-spirometric (oscillometry) measurements of the small airways to provide a comprehensive evaluation of respiratory function. Results: This study, conducted from July 2021 to March 2024, enrolled 40 patients with severe asthma, ultimately analyzing data from 31 participants who underwent biological therapy. The results showed significant improvements in asthma symptoms, the ACT scores increased significantly from visit 1 to visit 2 (p = 0.00008) and from visit 1 to visit 3 (p = 0.00047), and pulmonary function tests, with notable increases in FEV1 (from visit 1 (74.97 ± 23.43%) to visit 2 (82.96 ± 26.57%, p = 0.041) and to visit 3 (88.89 ± 31.41%, p = 0.003)) and quality of life scores, and substantial reductions in specific airway resistance and small airway dysfunction markers (the PEF, %pr post-BD showed significant improvement from visit 1 to visit 3 (p = 0.012)). However, oscillometric measurements showed no significant changes post-therapy. Conclusions: The study concluded that there was an improvement in the small airways measured by non-oscillometric values, without significant improvements in oscillometric parameters. Additionally, a significant improvement in symptoms was observed after the first month of therapy. There was also a significant increase in respiratory function after one to three months of therapy. [ABSTRACT FROM AUTHOR]

AbstractNanotechnology has significantly impacted drug discovery and development over the past three decades, offering novel insights and expanded treatment options. Key to this field is nanoparticles, ranging from 1 to 100 nanometres, with unique properties distinct from larger materials. Selenium nanoparticles (SeNPs) are particularly promising due to their low toxicity and selective cytotoxicity against cancer cells. They have shown efficacy in reducing various cancers types and mitigating conditions like diabetic nephropathy and neurological disorders, such as Alzheimer’s disease. This review highlights SeNPs’ role in enhancing drug delivery systems, improving the absorption of water-soluble compounds, proteins, peptides, vaccines, and other biological therapies. By modifying nanoparticle surfaces with targeting ligands, drug delivery can achieve precise site-specific delivery, increasing effectiveness. SeNPs can be synthesised through physical, chemical, and biological methods, each offering advantages in stability, size, and application potential. Additionally, SeNPs enhance immune responses and reduce oxidative stress, validating their role in biotherapy and nanomedicine. Their ability to target macrophages and regulate polarisation underscores their potential in antimicrobial therapies. Recent advancements, such as mannosylated SeNPs for targeted delivery, exemplify innovative nanotechnology applications in medicine. Overall, SeNPs represent a promising frontier in nanomedicine, offering new avenues for treating and managing various diseases. [ABSTRACT FROM AUTHOR]