Sujet(s)
Psoriasis , Indice de gravité de la maladie , Ustékinumab , Uvéite , Humains , Psoriasis/traitement médicamenteux , Ustékinumab/usage thérapeutique , Ustékinumab/effets indésirables , Femelle , Mâle , Adulte d'âge moyen , Uvéite/traitement médicamenteux , Adulte , Facteurs de risque , Facteur de nécrose tumorale alpha/antagonistes et inhibiteurs , Adalimumab/usage thérapeutique , Adalimumab/effets indésirables , Résultat thérapeutique , Étanercept/usage thérapeutique , Étanercept/effets indésirables , Appréciation des risques , Produits dermatologiques/usage thérapeutique , Produits dermatologiques/effets indésirables , Infliximab/usage thérapeutique , Infliximab/effets indésirablesRÉSUMÉ
BACKGROUND: Juvenile idiopathic arthritis (JIA) is the most common chronic inflammatory rheumatic disease in children, and adalimumab is one of the primary treatment options. Although it is widely used for inflammatory diseases, there is limited research on its safety and efficacy in patients with psychiatric disorders or in those with inflammatory diseases who also have comorbid psychiatric conditions. CASE REPORT: We report a 12-year-old adolescent boy who presented with emotional instability for 1 year, exacerbated leading to hospital admission in the past month. Upon detailed evaluation after admission, it was found that the patient's emotional fluctuations may be related to the use of Adalimumab. Follow-up after psychiatric inpatient treatment revealed that the patient did not experience emotional excitement again after discontinuing Adalimumab. CONCLUSIONS: Although tumor necrosis factor-α inhibitors have positive effects on the emotional, cognitive, and physical functions of patients with inflammatory diseases, their use may induce mood swings in patients with comorbid mood disorders. This is particularly important for adolescents with rapid mood changes, where greater caution is required. Further research is necessary to clarify the correlation between the adverse effects of these drugs and their impact on patients with bipolar disorder.
Sujet(s)
Adalimumab , Antirhumatismaux , Arthrite juvénile , Trouble bipolaire , Humains , Arthrite juvénile/traitement médicamenteux , Arthrite juvénile/complications , Mâle , Adalimumab/effets indésirables , Adalimumab/usage thérapeutique , Enfant , Antirhumatismaux/effets indésirables , Antirhumatismaux/usage thérapeutique , Trouble bipolaire/traitement médicamenteux , Manie/induit chimiquement , AdolescentSujet(s)
Adalimumab , Humains , Adalimumab/effets indésirables , Vascularite/induit chimiquement , Dépression/traitement médicamenteux , Déficits immunitaires/induit chimiquement , Déficits immunitaires/complications , Déficits immunitaires/traitement médicamenteux , Femelle , Mâle , Antirhumatismaux/effets indésirables , Maladies auto-inflammatoires héréditairesSujet(s)
Adalimumab , Protéines proto-oncogènes B-raf , Syndrome uvéo-méningo-encéphalique , Humains , Adalimumab/usage thérapeutique , Adalimumab/effets indésirables , Syndrome uvéo-méningo-encéphalique/traitement médicamenteux , Protéines proto-oncogènes B-raf/antagonistes et inhibiteurs , Protéines proto-oncogènes B-raf/génétique , Résistance aux substances , Femelle , Inhibiteurs de protéines kinases/effets indésirables , Inhibiteurs de protéines kinases/usage thérapeutique , Mâle , Anti-inflammatoires/usage thérapeutique , Anti-inflammatoires/effets indésirables , Adulte d'âge moyen , Sulfonamides/usage thérapeutique , Sulfonamides/effets indésirablesRÉSUMÉ
Crohn's disease (CD) is a type of inflammatory bowel disease (IBD) affecting the gastrointestinal tract that can also cause extra-intestinal complications. Following exposure to the mRNA vaccine BNT162b2 (Pfizer-BioNTech) encoding the SARS-CoV-2 Spike (S) protein, some patients experienced a lack of response to the biological drug Adalimumab and a recrudescence of the disease. In CD patients in progression, resistant to considered biological therapy, an abnormal increase in intestinal permeability was observed, more often with a modulated expression of different proteins such as Aquaporin 8 (AQP8) and in tight junctions (e.g., ZO-1, Claudin1, Claudin2, Occludin), especially during disease flares. The aim of this study is to investigate how the SARS-CoV-2 vaccine could interfere with IBD therapy and contribute to disease exacerbation. We investigated the role of the SARS-CoV-2 Spike protein, transported by extracellular vesicles (EVs), and the impact of various EVs components, namely, exosomes (EXOs) and microvesicles (MVs), in modulating the expression of molecules involved in the exacerbation of CD, which remains unknown.
Sujet(s)
Adalimumab , COVID-19 , Maladie de Crohn , Vésicules extracellulaires , SARS-CoV-2 , Glycoprotéine de spicule des coronavirus , Humains , Maladie de Crohn/traitement médicamenteux , Maladie de Crohn/métabolisme , Adalimumab/usage thérapeutique , Adalimumab/effets indésirables , COVID-19/prévention et contrôle , COVID-19/immunologie , Vésicules extracellulaires/métabolisme , Glycoprotéine de spicule des coronavirus/métabolisme , Glycoprotéine de spicule des coronavirus/immunologie , Vaccins contre la COVID-19/effets indésirables , Vaccin BNT162 , Femelle , Mâle , AdulteSujet(s)
Hidrosadénite suppurée , Psoriasis , Hidrosadénite suppurée/traitement médicamenteux , Hidrosadénite suppurée/complications , Hidrosadénite suppurée/induit chimiquement , Humains , Psoriasis/traitement médicamenteux , Facteur de nécrose tumorale alpha/antagonistes et inhibiteurs , Adalimumab/effets indésirables , Adalimumab/usage thérapeutiqueRÉSUMÉ
As a common treatment for rheumatoid arthritis (RA), the adverse reactions of TNF-α inhibitors (TNFis) in practical application have garnered attention. This study aims to investigate the adverse drug events (ADEs) associated with TNFi in RA patients as reported in the FDA Adverse Event Reporting System, to offer insights for clinical use. Cases related to RA and primarily involving TNFi were extracted from the FDA Adverse Event Reporting System database and compared by gender stratification. Screening was conducted based on reporting odds ratio and information component to identify positive ADEs for different TNFis and evaluate common and unique ADEs among various TNFis. There are 4 common ADEs among TNFis, including pulmonary tuberculosis, infection, hypersensitivity, and herpes zoster, as described in the package inserts. However, each TNFi has unique positive ADEs. Adalimumab has 63 unique positive ADEs, including lower respiratory tract inflammation, systemic lupus erythematosus rash, vascular dementia, ovarian neoplasm, adhesion, sarcoma, coccidioidomycosis, etc. Golimumab has 6 unique positive ADEs, including pneumonia cryptococcal, device deployment issue, pneumonia bacterial, polyneuropathy, device malfunction, device issue, etc; certolizumab has 24 unique positive ADEs, including maternal exposure before pregnancy, premature rupture of membranes, exposure via breast milk, staphylococcal sepsis, erysipelas, low birth weight baby, herpes virus infection, premature delivery, etc; etanercept has 180 unique positive ADEs, including joint destruction, chondrolysis, finger deformity, ankle deformity, joint warmth, etc; infliximab has 60 unique positive ADEs, including Hodgkin's disease, metastatic neoplasm, non-Hodgkin's Lymphoma, etc. Although the aforementioned 5 TNFis share common ADEs such as herpes zoster, clinicians must exercise caution when selecting specific medications, especially for RA patients concurrently suffering from malignancies. The analysis indicates that infliximab is associated with 60 unique positive ADEs, including Hodgkin's disease, metastatic neoplasm, and non-Hodgkin's lymphoma; therefore, these patients should use infliximab with greater caution. Similarly, certolizumab should be used with increased caution in pregnant and postpartum women.
Sujet(s)
Systèmes de signalement des effets indésirables des médicaments , Polyarthrite rhumatoïde , Facteur de nécrose tumorale alpha , Food and Drug Administration (USA) , Humains , États-Unis/épidémiologie , Femelle , Systèmes de signalement des effets indésirables des médicaments/statistiques et données numériques , Mâle , Polyarthrite rhumatoïde/traitement médicamenteux , Facteur de nécrose tumorale alpha/antagonistes et inhibiteurs , Antirhumatismaux/effets indésirables , Adulte d'âge moyen , Anticorps monoclonaux/effets indésirables , Adalimumab/effets indésirables , AdulteRÉSUMÉ
Adalimumab is a human monoclonal antibody that selectively targets tumour necrosis factor-alpha (TNF- α), a cytokine involved in the pathogenesis of various inflammatory and autoimmune disorders. Adalimumab has been approved worldwide for the treatment of several chronic immune-mediated diseases, including rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and juvenile idiopathic arthritis. One of the adverse reactions caused by Adalimumab is psoriasis. This study reports the case of a 37-year-old male with palmoplantar psoriasis triggered by adalimumab for treatment of Crohn's disease. This eruption resisted complete clearance with various potent corticosteroids. The patient was referred back to the treating rheumatologist to possibly change adalimumab to another type of therapy.
Sujet(s)
Adalimumab , Anti-inflammatoires , Maladie de Crohn , Psoriasis , Humains , Adalimumab/effets indésirables , Adalimumab/usage thérapeutique , Maladie de Crohn/traitement médicamenteux , Mâle , Adulte , Psoriasis/induit chimiquement , Psoriasis/traitement médicamenteux , Anti-inflammatoires/effets indésirables , Anti-inflammatoires/usage thérapeutiqueRÉSUMÉ
BACKGROUND: Although biologic agents are very effective, long-term comparative studies demonstrating their safety relative to one another are still lacking. METHODS: A total of 124 patients with psoriasis were followed up for 30 months; 74 received anti-TNF-alpha inhibitors (adalimumab, etanercept, infliximab), 33 were on ustekinumab, and 17 were treated with secukinumab. The rates of adverse events in these groups were recorded and statistically analyzed. RESULTS: Infliximab-treated patients showed a high occurrence of asymptomatic, but increased liver enzymes, fatigue, and respiratory as well as dermatologic infections. Adalimumab-treated patients were more often affected by musculoskeletal disorders and infections of all types. Patients treated with secukinumab presented with higher rates of cardiovascular disorders as well as respiratory and dermatologic infections. The group receiving etanercept was more often diagnosed with musculoskeletal and reproductive disorders, specifically menstrual disorders. The rates of therapy discontinuation and serious adverse events did not reach statistically significant values. CONCLUSION: A higher incidence of adverse events was observed among adalimumab-, and infliximab-treated patients, with ustekinumab found to have the safest profile. Our results demonstrate that a personalized approach, including evaluation of a patient's risk profile, is necessary before commencing a biologic. Further research is warranted to confirm the findings of our study.
Sujet(s)
Adalimumab , Anticorps monoclonaux humanisés , Étanercept , Infliximab , Psoriasis , Ustékinumab , Humains , Psoriasis/traitement médicamenteux , Femelle , Mâle , Ustékinumab/usage thérapeutique , Ustékinumab/effets indésirables , Études prospectives , Adalimumab/effets indésirables , Adalimumab/usage thérapeutique , Infliximab/effets indésirables , Infliximab/usage thérapeutique , Adulte d'âge moyen , Adulte , Étanercept/effets indésirables , Étanercept/usage thérapeutique , Anticorps monoclonaux humanisés/effets indésirables , Anticorps monoclonaux humanisés/usage thérapeutique , Anticorps monoclonaux/effets indésirables , Anticorps monoclonaux/usage thérapeutique , Études de cohortes , Produits dermatologiques/effets indésirables , Produits dermatologiques/usage thérapeutiqueRÉSUMÉ
A rare neuroendocrine skin cancer called Merkel cell carcinoma (MCC) primarily affects elderly people. The objective of this study is to comprehensively review the impact of immunosuppressive medications, particularly TNF inhibitors, on the emergence of MCC. METHODS: PubMed, Web of Science, Science Direct, and Cochrane Library were searched. Study articles were screened by title and abstract at Rayyan Qatar Computing Research Institute, then a full-text assessment was implemented. RESULTS: A total of eight case reports with 9 patients were included. Of the total population, seven were women and only two were men. Their age ranged from 31 to 73 years. More than half the population (5 cases) were being treated for rheumatoid arthritis. All received TNF inhibitors that were associated with the induction of MCC. CONCLUSION: We found that it is essential for physicians to explain potential cancer risks to patients before starting long-term immunosuppressive therapy and to conduct routine checks for MCC and other side effects. TNF inhibitors (infliximab, adalimumab, etanercept, and golimumab) were all associated with MCC development. Women constituted the majority of cases and most were elderly.
Sujet(s)
Carcinome à cellules de Merkel , Étanercept , Tumeurs cutanées , Inhibiteurs du facteur de nécrose tumorale , Humains , Carcinome à cellules de Merkel/induit chimiquement , Carcinome à cellules de Merkel/anatomopathologie , Carcinome à cellules de Merkel/traitement médicamenteux , Tumeurs cutanées/anatomopathologie , Tumeurs cutanées/induit chimiquement , Tumeurs cutanées/traitement médicamenteux , Adulte d'âge moyen , Inhibiteurs du facteur de nécrose tumorale/usage thérapeutique , Inhibiteurs du facteur de nécrose tumorale/effets indésirables , Étanercept/usage thérapeutique , Étanercept/effets indésirables , Sujet âgé , Femelle , Mâle , Infliximab/usage thérapeutique , Infliximab/effets indésirables , Anticorps monoclonaux/effets indésirables , Anticorps monoclonaux/usage thérapeutique , Adalimumab/usage thérapeutique , Adalimumab/effets indésirables , Adulte , Immunosuppresseurs/usage thérapeutique , Immunosuppresseurs/effets indésirables , Polyarthrite rhumatoïde/traitement médicamenteux , Facteur de nécrose tumorale alpha/antagonistes et inhibiteursRÉSUMÉ
This report describes a case of facial hyperpigmentation in a patient with Crohn's disease receiving adalimumab, a tumor necrosis factor (TNF)-alpha inhibitor. The onset of hyperpigmentation coincided with adalimumab administration, and its discontinuation resulted in significant improvement. Histopathological findings suggest a postinflammatory process at the dermo-epidermal junction. However, the precise mechanism remains unclear.
Sujet(s)
Adalimumab , Maladie de Crohn , Hyperpigmentation , Humains , Adalimumab/effets indésirables , Hyperpigmentation/induit chimiquement , Hyperpigmentation/anatomopathologie , Maladie de Crohn/traitement médicamenteux , Anti-inflammatoires/effets indésirables , Anti-inflammatoires/usage thérapeutique , Femelle , Adulte , Facteur de nécrose tumorale alpha/antagonistes et inhibiteurs , Face/anatomopathologie , MâleSujet(s)
Dermatite exfoliatrice , Interleukine-17 , Psoriasis , Humains , Psoriasis/traitement médicamenteux , Psoriasis/immunologie , Interleukine-17/antagonistes et inhibiteurs , Interleukine-17/immunologie , Études rétrospectives , Mâle , Femelle , Résultat thérapeutique , Adulte d'âge moyen , Dermatite exfoliatrice/traitement médicamenteux , Adulte , Anticorps monoclonaux humanisés/effets indésirables , Anticorps monoclonaux humanisés/usage thérapeutique , Produits dermatologiques/usage thérapeutique , Produits dermatologiques/effets indésirables , Sujet âgé , Indice de gravité de la maladie , Adalimumab/usage thérapeutique , Adalimumab/effets indésirablesRÉSUMÉ
BACKGROUND: To evaluate the risk of neutropenia during treatment with anti-IL-23 antibodies in patients with psoriasis. METHOD: We conducted an observational study with cohort design using MID-NET® in Japan. We identified patients with psoriasis who were newly prescribed anti-IL-23 antibodies, anti-IL-17-antibodies, adalimumab, or apremilast between January 1, 2009, and March 31, 2021. We estimated the adjusted hazard ratio (aHR) of anti-IL-23 antibodies compared to that of anti-IL-17 antibodies, adalimumab, or apremilast, for the risk of grade 2 (neutrophil count < 1,500/µL) or grade 3 (neutrophil count < 1,000/µL) neutropenia. RESULTS: Overall, 287 patients on anti-IL-23 antibodies, 189 patients on anti-IL-17 antibodies, 293 patients on adalimumab, and 540 patients on apremilast were included. Compared with anti-IL-17 antibodies, the aHR (95% confidence interval (CI)) of anti-IL-23 antibodies was 0.83 (0.27-2.51) for grade 2 and 0.40 (0.02-7.60) for grade 3 neutropenia; that when compared with adalimumab was 0.76 (0.28-2.06) for grade 2 but was not calculated for grade 3 as no cases were found; and that compared with apremilast was 3.88 (0.62-24.48) for grade 2 and 0.43 (0.02-11.63) for grade 3 neutropenia. CONCLUSION: No clear increase in the risk of neutropenia with anti-IL-23 antibodies was observed.
Sujet(s)
Adalimumab , Interleukine-17 , Interleukine-23 , Neutropénie , Psoriasis , Thalidomide , Humains , Adalimumab/effets indésirables , Adalimumab/immunologie , Psoriasis/traitement médicamenteux , Psoriasis/immunologie , Femelle , Mâle , Neutropénie/induit chimiquement , Neutropénie/immunologie , Neutropénie/épidémiologie , Adulte d'âge moyen , Japon , Adulte , Interleukine-17/antagonistes et inhibiteurs , Interleukine-17/immunologie , Interleukine-23/antagonistes et inhibiteurs , Interleukine-23/immunologie , Thalidomide/effets indésirables , Thalidomide/analogues et dérivés , Sujet âgé , Anticorps monoclonaux humanisés/effets indésirablesSujet(s)
Psoriasis , Humains , Psoriasis/traitement médicamenteux , Mâle , Femelle , République de Corée/épidémiologie , Sujet âgé , Adulte d'âge moyen , Résultat thérapeutique , Adalimumab/usage thérapeutique , Adalimumab/effets indésirables , Études rétrospectives , Anticorps monoclonaux humanisés/effets indésirables , Anticorps monoclonaux humanisés/usage thérapeutique , Facteurs âges , Étanercept/usage thérapeutique , Étanercept/effets indésirables , Infliximab/usage thérapeutique , Infliximab/effets indésirables , Indice de gravité de la maladieRÉSUMÉ
OBJECTIVE: MSB11022 is a biosimilar of adalimumab that has been shown comparable bioequivalence, safety, tolerability, and immunogenicity profiles to the reference adalimumab in healthy volunteers or in patients with psoriasis or rheumatoid arthritis (RA). This is the first study conducted under clinical practice conditions evaluating the switch from reference adalimumab to MSB11022 in patients with RA. METHODS: Retrospective and multicenter study with data from the medical records of patients with RA who switched from reference adalimumab or another biosimilar to MSB11022 and maintained this treatment for at least 6 months. Information registered comes from baseline visit, the moment of the switch, and the follow-up visits. RESULTS: Data from 86 patients were evaluated (median age 63.5 years, 75.6% female, 44.2% had erosive RA). Only 3.5% of the patients received biologic therapy prior to adalimumab. At baseline, median DAS28-CRP was 1.77 (80.2% in remission and 96.5% with low disease activity) and median CDAI was 4.00 (44.2% in remission and 90.7% with low disease activity). After a median follow-up of 8 months, median DAS28-CRP was 1.87 (86.0% in remission and 94.2% with low disease activity) and median CDAI was 4.00 (38.5% in remission and 95.3% with low disease activity). Only three patients experienced pain, swelling, and stinging at the injection site or a locally extensive hematoma in the area of administration. CONCLUSIONS: Adalimumab biosimilar MSB11022 maintained the efficacy benefits provided by previous adalimumab treatments with a safety profile in line with that already described for other biosimilars.
Sujet(s)
Adalimumab , Antirhumatismaux , Polyarthrite rhumatoïde , Produits pharmaceutiques biosimilaires , Enregistrements , Humains , Adalimumab/administration et posologie , Adalimumab/usage thérapeutique , Adalimumab/effets indésirables , Femelle , Adulte d'âge moyen , Mâle , Polyarthrite rhumatoïde/traitement médicamenteux , Produits pharmaceutiques biosimilaires/administration et posologie , Produits pharmaceutiques biosimilaires/usage thérapeutique , Produits pharmaceutiques biosimilaires/effets indésirables , Antirhumatismaux/usage thérapeutique , Antirhumatismaux/administration et posologie , Antirhumatismaux/effets indésirables , Sujet âgé , Espagne , Études rétrospectives , Résultat thérapeutique , Substitution de médicament/statistiques et données numériques , AdulteRÉSUMÉ
OBJECTIVE: To analyze the long-term survival of subcutaneous biosimilar tumor necrosis factor inhibitors compared to the originator molecules in patients with rheumatic diseases, as well as the factors associated with drug discontinuation. METHODS: Retrospective analysis of BIOBADASER, the Spanish multicenter prospective registry of patients with rheumatic disease receiving biologic and targeted disease-modifying antirheumatic drugs. Patients who started etanercept (ETN) or adalimumab (ADA) from January 2016 to October 2023 were included. The survival probabilities of biosimilars and originators were compared using Kaplan-Meier estimating curves. To identify factors associated with differences in the retention rates, hazard ratios (HR) were estimated using Cox regression models for all and specific causes (inefficacy or adverse events [AEs]) of discontinuation. RESULTS: A total of 4162 patients received 4723 treatment courses (2991 courses of ADA and 1732 courses of ETN), of which 722 (15.29%) were with originator molecules and 4001 (84.71%) were with biosimilars. The originators were more frequently discontinued than biosimilars (53.32% vs 33.37%, respectively). The main reason for discontinuation was inefficacy (60.35% of the treatments). The risk of overall discontinuation was lower for biosimilars (adjusted HR 0.84, 95% CI 0.75-0.95). Female sex, obesity, and second or later treatment lines increased the risk of discontinuation, whereas disease duration and the use of concomitant methotrexate were associated with a greater survival. When assessing cause-specific reasons of discontinuation, excluding nonmedical switching, the results from the crude and adjusted analyses showed no significant differences in the retention rate between biosimilars and originators. CONCLUSION: No significant differences were found between treatments in long-term survival due to inefficacy or AEs.
Sujet(s)
Adalimumab , Antirhumatismaux , Produits pharmaceutiques biosimilaires , Étanercept , Enregistrements , Rhumatismes , Humains , Femelle , Produits pharmaceutiques biosimilaires/usage thérapeutique , Produits pharmaceutiques biosimilaires/administration et posologie , Mâle , Adulte d'âge moyen , Antirhumatismaux/usage thérapeutique , Antirhumatismaux/administration et posologie , Antirhumatismaux/effets indésirables , Adalimumab/usage thérapeutique , Adalimumab/administration et posologie , Adalimumab/effets indésirables , Étanercept/usage thérapeutique , Étanercept/administration et posologie , Adulte , Sujet âgé , Études rétrospectives , Rhumatismes/traitement médicamenteux , Rhumatismes/mortalité , Études prospectives , Inhibiteurs du facteur de nécrose tumorale/usage thérapeutique , Inhibiteurs du facteur de nécrose tumorale/effets indésirables , Résultat thérapeutique , Injections sous-cutanées , Facteur de nécrose tumorale alpha/antagonistes et inhibiteurs , Espagne/épidémiologieRÉSUMÉ
Introduction: Acquired Hemophilia A (AHA) is a rare autoimmune disorder characterized by the emergence of inhibitors that specifically target coagulation Factor VIII, frequently resulting in severe bleeding episodes. Methods: We conducted a retrospective analysis of the medical records of a 68-year-old male patient who presented with adalimumab-induced AHA. Results: The patient received adalimumab, a tumor necrosis factor inhibitor antibody, as part of his treatment for rheumatoid arthritis. The patient's clinical journey, characterized by intense bleeding and coagulopathy, was effectively managed with the application of recombinant Factor VIIa (rFVIIa) and the CyDRi protocol. Discussion: The case emphasizes the importance of prompt coagulation assessment in patients with bleeding symptoms receiving disease-modifying therapy for rheumatoid arthritis that includes adalimumab therapy, considering the rare yet life-threatening nature of AHA. Additionally, this report provides an extensive review of the existing literature on drug-induced AHA, with a special emphasis on cases linked to immunomodulatory medications. Through this two-pronged approach, our report aims to enhance understanding and awareness of this severe complication among healthcare providers, promoting timely diagnosis and intervention.
Sujet(s)
Adalimumab , Hémophilie A , Humains , Hémophilie A/traitement médicamenteux , Hémophilie A/induit chimiquement , Mâle , Sujet âgé , Adalimumab/effets indésirables , Adalimumab/usage thérapeutique , Polyarthrite rhumatoïde/traitement médicamenteux , Facteur VIIa/usage thérapeutique , Antirhumatismaux/usage thérapeutique , Antirhumatismaux/effets indésirables , Rituximab/usage thérapeutique , Rituximab/effets indésirables , Études rétrospectives , Protéines recombinantes/usage thérapeutiqueRÉSUMÉ
OBJECTIVES: To assess the safety and efficacy of upadacitinib versus adalimumab from SELECT-COMPARE over 5 years. METHODS: Patients with rheumatoid arthritis and inadequate response to methotrexate were randomised to receive upadacitinib 15 mg once daily, placebo or adalimumab 40 mg every other week, all with concomitant methotrexate. By week 26, patients with insufficient response to randomised treatment were rescued; patients remaining on placebo switched to upadacitinib. Patients completing the 48-week double-blind period could enter a long-term extension. Safety and efficacy were assessed through week 264, with radiographic progression analysed through week 192. Safety was assessed by treatment-emergent adverse events (TEAEs). Efficacy was analysed by randomised group (non-responder imputation (NRI)) or treatment sequence (as observed). RESULTS: Rates of TEAEs were generally similar with upadacitinib versus adalimumab, although numerically higher rates of herpes zoster, lymphopenia, creatine phosphokinase elevation, hepatic disorder and non-melanoma skin cancer were reported with upadacitinib. Numerically greater proportions of patients randomised to upadacitinib versus adalimumab achieved clinical responses (NRI); Clinical Disease Activity Index remission (≤2.8) and Disease Activity Score based on C reactive protein <2.6 were achieved by 24.6% vs 18.7% (nominal p=0.042) and 31.8% vs 23.2% (nominal p=0.006), respectively. Radiographic progression was numerically lower with continuous upadacitinib versus adalimumab at week 192. CONCLUSION: The safety profile of upadacitinib through 5 years was consistent with the known safety profile of upadacitinib, with no new safety risks. Clinical responses were numerically higher with upadacitinib versus adalimumab at 5 years. Upadacitinib demonstrates a favourable benefit-risk profile for long-term rheumatoid arthritis treatment. TRIAL REGISTRATION NUMBER: NCT02629159.
Sujet(s)
Adalimumab , Antirhumatismaux , Polyarthrite rhumatoïde , Composés hétérocycliques 3 noyaux , Humains , Polyarthrite rhumatoïde/traitement médicamenteux , Adalimumab/usage thérapeutique , Adalimumab/administration et posologie , Adalimumab/effets indésirables , Composés hétérocycliques 3 noyaux/usage thérapeutique , Composés hétérocycliques 3 noyaux/effets indésirables , Composés hétérocycliques 3 noyaux/administration et posologie , Femelle , Antirhumatismaux/usage thérapeutique , Antirhumatismaux/effets indésirables , Antirhumatismaux/administration et posologie , Mâle , Adulte d'âge moyen , Résultat thérapeutique , Méthode en double aveugle , Adulte , Méthotrexate/usage thérapeutique , Méthotrexate/administration et posologie , Méthotrexate/effets indésirables , Sujet âgé , Association de médicamentsRÉSUMÉ
This post hoc analysis of PIONEER I and II randomized clinical trials assesses whether receiving adalimumab is associated with decreased hematologic abnormalities and increased clinical improvement in patients with hidradenitis suppurativa.
Sujet(s)
Adalimumab , Hidrosadénite suppurée , Humains , Hidrosadénite suppurée/traitement médicamenteux , Adalimumab/effets indésirables , Adalimumab/usage thérapeutique , Adalimumab/administration et posologie , Femelle , Mâle , Adulte , Adulte d'âge moyen , Hémopathies , Anti-inflammatoires/usage thérapeutique , Anti-inflammatoires/administration et posologie , Anti-inflammatoires/effets indésirablesRÉSUMÉ
BACKGROUND: Tumor necrosis factor-α inhibitors (TNFis) are used for the treatment of inflammatory bowel disease (IBD). The aim of this study was to evaluate the association between neurological adverse events (AEs) and TNFi use. METHODS: Data of TNFis indicated for IBD were collected from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the marketed date to the second quarter of 2023. The reporting odds ratio (ROR) and a Bayesian confidence propagation neural network were used to identify signals. RESULTS: A total of 4,964 neurological AEs were reported in the IBD population. Infliximab had 3 signals, including demyelination [ROR (95% CI): 1.69 (1.33,2.15)], meningitis listeria [ROR (95% CI): 5.05 (3.52,7.25)], and optic neuritis [ROR (95% CI): 1.72 (1.3,2.26)]. The signals for adalimumab were gait disturbance [ROR (95% CI): 1.43 (1.32,1.56)] and muscular weakness [ROR (95% CI): 1.4 (1.27,1.55)]. A peripheral neuropathy signal was found for adalimumab [ROR (95% CI): 1.34 (1.18,1.53)] and certolizumab pegol [ROR (95% CI): 1.49 (1.07,2.08)]. However, there were no signals among neurological AEs for golimumab. CONCLUSION: Neurological signals were detected for TNFi use, indicating that the risk of neurological AEs requires additional attention in clinical use of TNFis.