Clinical Drug Investigation最新文献

{"title":"Authors' Reply to Noguchi et al. Comment on: \"Differences in the Adverse Event Profiles of Sodium-Glucose Cotransporter 2 Inhibitors Used in Patients with Diabetes and Heart Failure: An Analysis Using the Japanese Adverse Drug Event Report Database\".","authors":"Toshiaki Sakamoto, Hirotaka Miyamoto, Junya Hashizume, Hayato Akamatsu, Tomoaki Akagi, Yukinobu Kodama, Hirofumi Hamano, Yoshito Zamami, Kaname Ohyama","doi":"10.1007/s40261-024-01414-7","DOIUrl":"https://doi.org/10.1007/s40261-024-01414-7","url":null,"abstract":"","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881402","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment on: \"Differences in the Adverse Event Profiles of Sodium-Glucose Cotransporter 2 Inhibitors used in Patients with Diabetes Mellitus and Heart Failure: An Analysis Using the Japanese Adverse Drug Event Report Database.\"","authors":"Yoshihiro Noguchi, Keiko Suzuki, Yoko Ino, Tomoaki Yoshimura","doi":"10.1007/s40261-024-01407-6","DOIUrl":"https://doi.org/10.1007/s40261-024-01407-6","url":null,"abstract":"","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing Individualized Antimicrobial Dosing in Pediatric Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.","authors":"Nadir Yalçın, Yağmur Dirik, İzgi Bayraktar, Mutlu Umaroğlu, Karel Allegaert","doi":"10.1007/s40261-024-01415-6","DOIUrl":"https://doi.org/10.1007/s40261-024-01415-6","url":null,"abstract":"<p><strong>Background: </strong>Therapeutic drug monitoring (TDM) and target concentration intervention (TCI) represent significant advancements in individualized medicine, aiming to tailor dosages based on patient-specific characteristics. These approaches account for intra- and inter-individual physiological and clinical variability, with the goal of improving target attainment and clinical remission while reducing treatment failure and adverse effects.</p><p><strong>Objectives: </strong>The objective is to assess and enhance the current body of randomized controlled trials (RCTs) that have investigated alternative personalized dosing strategies, such as TDM and TCI, in terms of their efficacy and safety for individualized antimicrobial dosing in pediatric populations. Only studies that compared different dosing regimens and reported plasma concentrations were included in the analysis.</p><p><strong>Methods: </strong>Databases such as MEDLINE, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials were searched until January 3rd, 2024. Only published, peer-reviewed RCTs were considered for inclusion. The study focused on human subjects aged < 18 years who were receiving an antimicrobial drug. The interventions compared experimental dosing versus standard dosing with TDM or TCI. The risk of bias was assessed using version 2 of the Cochrane risk-of-bias tool for randomized trials. The primary outcome was the attainment of target concentrations, while secondary outcomes included adverse effects, clinical remission, and treatment failure. Data synthesis was performed using the restricted maximum likelihood method, and the risk ratio (RR) was used as the measure of effect size.</p><p><strong>Results: </strong>Only 11 TDM-based RCTs were included in the study [experimental vs standard doses: 592 (51.3%) patients vs 563 (48.7%) patients]. Experimental dose was significantly associated with improvement in target attainment (RR 1.2587, OR 1.0717-1.4786; p = 0.0051). However, experimental antimicrobial dose optimization was non-significantly associated with a numerical decrease in treatment failure (RR 0.8966, OR 0.7749-1.0374; p = 0.1424). In addition, it was not significant associated with higher adverse effects [RR 1.3408, odds ratio (OR) 0.1783-10.0825; p = 0.7757] and clinical remission rates (RR 4.0589, OR 0.2494-66.0558; p = 0.3250).</p><p><strong>Conclusions: </strong>This meta-analysis showed that only target attainment using TDM was significantly improved in pediatric patients treated with experimental doses of antimicrobials compared to standard doses. Larger TCI-focused RCTs are needed to significantly improve treatment failure, adverse effects, and clinical remission.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phenotypes of Patients with Direct Oral Anticoagulant (DOAC) Underdosing in Atrial Fibrillation: Results from the ARENA Registry.","authors":"Christine Brockmüller, Andreas D Meid, Jochen Senges, Matthias Hochadel, Walter E Haefeli, Felicitas Stoll","doi":"10.1007/s40261-024-01411-w","DOIUrl":"https://doi.org/10.1007/s40261-024-01411-w","url":null,"abstract":"<p><strong>Background and objectives: </strong>Oral anticoagulation in patients with atrial fibrillation is crucial to prevent thrombus formation in the heart, a major cause of ischemic stroke. The appropriate dose of direct oral anticoagulants (DOAC) - either standard or reduced dose - must be chosen individually in accordance with defined patient characteristics. However, a significant proportion of patients receive inappropriately low DOAC doses (underdosing). With a novel medication-based approach, this study aims to facilitate the identification of patients at risk of DOAC underdosing.</p><p><strong>Methods: </strong>The prospective ARENA registry is a multi-centre study on patients with atrial fibrillation in Germany. Patients gave detailed information on medication, including over-the-counter preparations. Medication data were grouped according to the Anatomical Therapeutic Chemical (ATC) classification. In a bivariate analysis, the characteristics of patients on an appropriate versus inappropriate dose were compared (n = 866). To further evaluate variables for their association with underdosing, a model based on ATC third level medication data complemented with dose-adjustment criteria and validated clinical scores in all patients with complete information was built (n = 504).</p><p><strong>Results: </strong>In 15% of patients, an inappropriately low dose was found. The number of DOAC drug interactions, concomitant antiplatelet therapy and the total drug count were the most important predictors of DOAC underdosing. Mineral supplements and better health-related quality of life (HrQoL) were predictive of correct DOAC dosing, among others.</p><p><strong>Conclusions: </strong>Medication-related data showed to be predictive of DOAC underdosing. Clinicians should check for inappropriately reduced DOAC doses, especially in patients undergoing antiplatelet therapy, polypharmacy and reduced HrQoL.</p><p><strong>Trial registration number: </strong>NCT02978248; date of registration: 30 November 2016.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acknowledgement to Referees.","authors":"","doi":"10.1007/s40261-024-01412-9","DOIUrl":"https://doi.org/10.1007/s40261-024-01412-9","url":null,"abstract":"","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142766818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of NUN-004, a Novel Engineered Ephrin Antagonist, in Healthy Volunteers and Patients with Amyotrophic Lateral Sclerosis: A Phase I/Ib, Open-Label, Escalating Dose and Extended Access Study.","authors":"Michael Gerometta, Robert D Henderson, Richard Friend, Leanne T Cooper, Jing Zhao, Andrew W Boyd, Perry F Bartlett","doi":"10.1007/s40261-024-01410-x","DOIUrl":"https://doi.org/10.1007/s40261-024-01410-x","url":null,"abstract":"<p><strong>Background: </strong>Erythropoietin-producing hepatocellular carcinoma A4 (EphA4) is implicated in the pathophysiology of amyotrophic lateral sclerosis. EphA4 fusion protein (EphA4-Fc) inhibits EphA4 function in vivo but is too short-lived for prolonged therapy. NUN-004 (mEphA4-Fc) is a modified EphA4-Fc engineered for an extended half-life.</p><p><strong>Objective: </strong>This first-in-human phase I/Ib study evaluated the safety, tolerability, pharmacokinetics, immunogenicity and efficacy of NUN-004 in healthy volunteers and patients with amyotrophic lateral sclerosis.</p><p><strong>Methods: </strong>In this open-label study, Part 1 enrolled 20 healthy volunteers in five single ascending dose cohorts (1, 3, 10, 20 and 30 mg/kg), followed by Part 2, which enrolled eight patients with amyotrophic lateral sclerosis in two multiple ascending dose cohorts (cycle 1: 15 and 30 mg/kg) who could continue into an extended access phase (cycles 2-6: 15 mg/kg) for a total of 6 months' treatment. All participants received intravenous NUN-004; multiple dosing was administered weekly in 28-day cycles. Primary endpoints included safety assessments, single-dose and multiple-dose pharmacokinetics, and anti-drug antibodies. Efficacy assessments were Amyotrophic Lateral Sclerosis Function Rating Score Revised (ALSFRS-R) and forced vital capacity.</p><p><strong>Results: </strong>NUN-004 was well tolerated, with no serious adverse events or discontinuations. NUN-004 exposure generally increased with dose. Single-dose half-life was 111.7 (± 22.8) h in healthy volunteers (n = 20) and 74.4 (± 19.4) h in patients (n = 6). Steady state was observed in patients by day 8. Steady-state half-life (cycle 1 doses 2-4) was 83.7 (± 26.6) to 101.1 (± 46.0) h. No antibody response was observed. ALSFRS-R showed a slight improvement (+0.09 points/month) to cycle 4 and a slight decline (-0.35 points/month) over the whole study. Forced vital capacity trends were consistent with ALSFRS-R.</p><p><strong>Conclusions: </strong>This study supports the safety, tolerability and extended half-life of NUN-004, and provides preliminary evidence for its ability to ameliorate disease progression in an amyotrophic lateral sclerosis cohort.</p><p><strong>Clinical trial registration: </strong>Registered on ANZCTR under identifier ACTRN12621000514808 (3 May, 2021).</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142766822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-Effectiveness Analysis of Adjuvant Pertuzumab and Trastuzumab in Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer in Japan.","authors":"Chanon Nusawat, So Sato, Hideaki Watanabe, Takaaki Konishi, Hayato Yamana, Hideo Yasunaga","doi":"10.1007/s40261-024-01399-3","DOIUrl":"10.1007/s40261-024-01399-3","url":null,"abstract":"<p><strong>Background and objective: </strong>Human epidermal growth factor receptor 2 (HER2)-positive breast cancer presents considerable treatment challenges owing to its aggressive nature. Global guidelines have endorsed a full year of HER2-targeted therapy for early-stage breast cancer. However, previous cost-effectiveness analyses of dual HER2-targeted therapies have been limited. This study aimed to examine the cost effectiveness of dual HER2-targeted therapy for early-stage breast cancer within the Japanese healthcare system context.</p><p><strong>Methods: </strong>In the Markov model-based study, the cost effectiveness of dual anti-HER2 therapy, combining pertuzumab and trastuzumab, was assessed in comparison to trastuzumab monotherapy. Patients in whom treatment was initiated at a median age of 51 years were included. The study utilized quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) as comparison units. Subgroup analyses were conducted to explore variations in cost effectiveness, focusing on node-positive and node-negative patients. Both one-way deterministic and broader probabilistic sensitivity analyses using Monte Carlo simulations with 10,000 samples were performed from the Japanese healthcare payers perspective.</p><p><strong>Results: </strong>Dual HER2-targeted therapy led to 0.17 QALYs increment at an additional cost of $US15,289, resulting in an ICER of $US92,232 per QALY. In the subgroup of node-positive patients, the benefit of the dual HER2-targeted therapy was more pronounced, with an increase of 0.64 QALYs and an ICER of $US24,561 per QALY. Sensitivity analyses revealed the model's susceptibility to changes in the transition probabilities from invasive disease-free survival to death, from invasive disease-free survival to first-line metastatic breast cancer, and to costs associated with pertuzumab. Probabilistic sensitivity analysis suggests that for node-positive patients, dual HER2-targeted therapy may be a cost-effective option.</p><p><strong>Conclusions: </strong>The economic viability of dual HER2-targeted therapy was most pronounced in patients with node-positive high-risk early breast cancer. This study highlights the potential of dual HER2-targeted therapy as a cost-effective addition for these cases.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"927-938"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11638282/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142603578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of Monthly Extended-Release Buprenorphine at Alternative Injection Locations in Adult Participants with Opioid Use Disorder.","authors":"Celine M Laffont, Olga Lapeyra, Dipti Mangal, Robert Dobbins","doi":"10.1007/s40261-024-01406-7","DOIUrl":"10.1007/s40261-024-01406-7","url":null,"abstract":"<p><strong>Background and objectives: </strong>Buprenorphine extended-release monthly formulation (BUP-XR, SUBLOCADE^®) is approved for treatment of moderate-to-severe opioid use disorder (OUD) following subcutaneous injection in the abdomen. This open-label pharmacokinetic study assessed three alternative injection locations (upper arm, thigh, buttocks) to offer additional flexibility considering the chronic nature of the disease and patient preferences.</p><p><strong>Methods: </strong>Following stabilization on 12/3 mg/day of sublingual buprenorphine/naloxone for ≥ 7 days, participants with moderate-to-severe OUD were randomized to receive a single 300-mg BUP-XR injection in the upper arm, thigh, buttocks, or abdomen (reference). Serial blood samples were taken to measure buprenorphine plasma concentrations over 28 days and assess buprenorphine relative bioavailability. Safety evaluations included treatment-emergent adverse events and assessments of injection site pain, tenderness, erythema, induration, and swelling.</p><p><strong>Results: </strong>A total of 88 participants received a single subcutaneous injection of 300-mg BUP-XR in the upper arm (N = 21), thigh (N = 23), buttocks (N = 22), or abdomen (N = 22); 81/88 (92%) completed the study. Buprenorphine plasma exposure (area under the plasma concentration-time curve over 28 days) was comparable across injection site groups with mean buprenorphine plasma concentrations sustained at approximately 2 ng/mL (therapeutic target concentration) or above. Buprenorphine maximum plasma concentration (C_max) was approximately 39% and 52% higher after injection in the upper arm and thigh, respectively, versus the abdomen, while comparable between buttocks and abdomen. Higher C_max values were not associated with an increased incidence of adverse events. Safety and injection site tolerability were comparable across injection groups.</p><p><strong>Conclusions: </strong>These pharmacokinetic and safety findings support BUP-XR injection into the upper arm, thigh, and buttocks.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov: NCT05704543.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"939-949"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11638319/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the Effectiveness of Additional Risk Minimisation Measures for Tofacitinib (Xeljanz^®) in Europe: A Prescriber Survey.","authors":"Joanne Wu, Nana Koram, Kofi Asomaning, Lubna Merchant, Robert Massouh, Edward Nagy, Subhan Khalid, Laura Walsh, Rafia Bosan, Krystal Cantos","doi":"10.1007/s40261-024-01408-5","DOIUrl":"10.1007/s40261-024-01408-5","url":null,"abstract":"<p><strong>Objective: </strong>We evaluated the effectiveness of tofacitinib (oral Janus kinase inhibitor) additional risk minimisation measures (aRMM) in Europe via prescriber surveys. Operational challenges/methodological limitations of surveys and recommendations for future considerations were summarised.</p><p><strong>Methods: </strong>In this post-authorisation safety study, multimodal surveys were conducted in eight European countries from 2021 to 2022 among prescribers of tofacitinib for rheumatoid arthritis and/or psoriatic arthritis (RA/PsA) or ulcerative colitis (UC) in the 12 months preceding survey administration. Prescribers' awareness (receipt) of aRMM materials, knowledge of key risk messages and adherence to risk minimisation practices were assessed. A priori effectiveness thresholds (≥ ~80%) were set across outcomes.</p><p><strong>Results: </strong>Of 18,764 and 12,777 prescribers invited to take the RA/PsA or UC survey, 164 and 81 completed the surveys, respectively (response proportion: 326/18,764, 1.7%; 154/12,777, 1.2%, respectively). Among completers, self-reported receipt of all initial and/or 2019 updated aRMM materials was 33.5% and 32.7% in the RA/PsA and UC surveys, respectively. In the RA/PsA and UC surveys, 39.5% and 24.5%, respectively, answered ≥ ~80% of knowledge questions correctly; 51.2% and 69.7%, respectively, provided desirable responses to ≥ ~80% of adherence questions.</p><p><strong>Conclusions: </strong>Although the tofacitinib aRMM materials did not achieve the desired effectiveness for awareness (receipt), knowledge or adherence to risk minimisation practices among survey completers, the study was deemed inconclusive given the low response rate. This demonstrated that unless an acceptable response rate is achieved, surveys should not be the only method for aRMM evaluation. Secondary data may supplement future surveys to increase their robustness.</p><p><strong>Hma-ema catalogues registration: </strong>EUPAS43143 (date of registration: 29/09/2021).</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"961-974"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11638417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Phase I Clinical Trial to Evaluate the Bioequivalence of an Adalimumab Biosimilar Adalimumab-WIBP and Humira^®.","authors":"Shengling Hu, Yang Liu, Lu Yang, Yunkai Yang, Feiguang Long, Hongying Bao, Huijun Zhang, Xin Yue, Jiayou Zhang, Zejun Wang, Chaolin Huang, Jingli Wang, Liu Xia, Yongbing Pan, Yuntao Zhang, Fengyun Gong","doi":"10.1007/s40261-024-01409-4","DOIUrl":"10.1007/s40261-024-01409-4","url":null,"abstract":"<p><strong>Background and objectives: </strong>The high costs associated with biological agents often limit accessibility for many patients, whereas biosimilars allow the wider application of biological treatment. The objectives of this phase I clinical trial were to compare the pharmacokinetics, immunogenicity, and safety profiles of the biosimilar adalimumab-WIBP and the reference product Humira^® and to assess the precision of the bioequivalence evaluation.</p><p><strong>Methods: </strong>In this randomized, double-blind, parallel-group bioequivalence study, 164 healthy male Chinese participants were selected and randomly divided into two groups on a 1:1 ratio. The subjects were administered a single 40 mg subcutaneous dose of either adalimumab-WIBP or Humira^®. Blood samples extracted at multiple intervals after administration were analyzed to interpret pharmacokinetic parameters, and any adverse events were documented. Alongside ensuring safety measures, the subjects were monitored for immunogenicity.</p><p><strong>Results: </strong>The pharmacokinetic results demonstrated similar serum concentration-time curves in both groups. There were no significant differences in safety and no differences in immunogenicity profiles between the two groups. The bioequivalence was confirmed: the 90% confidence interval for the geometric mean ratio of the main pharmacokinetic parameters was within the range of 80-125%.</p><p><strong>Conclusion: </strong>The trial indicated the bioequivalence between adalimumab-WIBP and the reference product Humira^® based on pharmacokinetics, immunogenicity, and safety profile. These findings reinforce the use of the adalimumab-WIBP biosimilar as a possible therapeutic alternative to Humira^®.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"951-960"},"PeriodicalIF":2.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}