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American Journal of Therapeutics 2020
Topics: Adalimumab; Hemorrhage; Humans; Pericarditis
PubMed: 31241494
DOI: 10.1097/MJT.0000000000001019 -
International Journal of Molecular... May 2023Hidradenitis suppurativa (HS) is an immune-mediated inflammatory disorder characterized by deep-seated nodules, abscesses, sinus tracts and scars localized in the... (Review)
Review
Hidradenitis suppurativa (HS) is an immune-mediated inflammatory disorder characterized by deep-seated nodules, abscesses, sinus tracts and scars localized in the intertriginous areas. It is accompanied by pain, malodourous secretion and a dramatically decreased quality of life. Although the pathogenesis has not been entirely elucidated, the primary event is follicular hyperkeratosis of the pilosebaceous apocrine unit. Since the registration of the tumor necrosis factor-alpha inhibitor Adalimumab in 2015, several cytokines have been implicated in the pathomechanism of HS and the research of novel therapeutic targets has been intensified. We provide an update on the inflammatory cytokines with a central role in HS pathogenesis and the most promising target molecules of future HS management.
Topics: Humans; Hidradenitis Suppurativa; Quality of Life; Adalimumab; Skin; Cytokines
PubMed: 37176138
DOI: 10.3390/ijms24098428 -
JAMA Dec 2019
Topics: Adalimumab; Anti-Inflammatory Agents; Antibodies, Monoclonal; Antirheumatic Agents; Biosimilar Pharmaceuticals; Drug Costs; Heterocyclic Compounds, 3-Ring; Humans; Patents as Topic; Time Factors; United States
PubMed: 31644784
DOI: 10.1001/jama.2019.16275 -
Drugs in R&D Dec 2023Adalimumab-aqvh/CHS-1420 (YUSIMRY) (hereafter referred to as adalimumab-aqvh) was recently approved by the US Food and Drug Administration as a biosimilar for adalimumab.
BACKGROUND
Adalimumab-aqvh/CHS-1420 (YUSIMRY) (hereafter referred to as adalimumab-aqvh) was recently approved by the US Food and Drug Administration as a biosimilar for adalimumab.
OBJECTIVE
The current study was conducted to investigate the analytical similarity of adalimumab-aqvh and the reference product, adalimumab.
METHODS
The structural, functional, and stability attributes of adalimumab-aqvh and adalimumab were compared using state-of-the-art assays. The primary structure, disulfide structure, glycan profile, secondary and tertiary structures, molar mass, size variants, free thiol, charge variants, hydrophobic variants, post-translational modifications, subvisible particles, host cell proteins, and protein concentration were investigated. The functional similarity between adalimumab-aqvh and adalimumab was demonstrated by comparing fragment antigen-binding (Fab)-associated and fragment crystallizable (Fc)-associated biological activities. The stability of adalimumab-aqvh and of adalimumab was compared through forced degradation.
RESULTS
The structural attributes of adalimumab-aqvh were identical to those of adalimumab or met the similarity criteria, with a few exceptions. Adalimumab-aqvh and adalimumab exhibited comparable stability profiles and functional activities. Any observed differences in the physiochemical attributes did not impact the conclusion of similarity because they did not influence any functional activities related to the adalimumab mechanism of action.
CONCLUSION
The structural, functional, and stability data provide convincing evidence of biosimilarity between adalimumab-aqvh and the reference product, adalimumab.
Topics: Humans; Adalimumab; Biosimilar Pharmaceuticals
PubMed: 37632627
DOI: 10.1007/s40268-023-00437-3 -
Arthritis Research & Therapy Oct 2022We compared the treatment effectiveness between guselkumab and adalimumab in patients with pustulotic arthro-osteitis (PAO). In addition, we performed peripheral blood...
OBJECTIVES
We compared the treatment effectiveness between guselkumab and adalimumab in patients with pustulotic arthro-osteitis (PAO). In addition, we performed peripheral blood immunophenotyping to elucidate the immunological background and analyzed the impact of therapeutic drugs to verify the validity of immunological phenotypes as therapeutic targets.
METHODS
Patients were treated with guselkumab 100 mg (guselkumab group; n = 12) and adalimumab 40 mg (adalimumab group; n = 13). Arthritis disease activity, skin lesion activity, and patient-reported outcomes (PROs) were evaluated and compared between the two groups. The retention rate and adverse events were evaluated. Comprehensive phenotyping of peripheral immune cells was performed in both groups, and phenotypes were compared before and after treatment.
RESULTS
At 6 months, both groups showed significant improvement in arthritis disease activity and PROs. In the guselkumab group, skin symptoms significantly improved. The 6-month continuation rates were 91.7% (11/12) and 69.2% (9/13) in the guselkumab and adalimumab groups, respectively. Adverse events occurred in 2/12 and 5/13 patients in the guselkumab (16.7%) and adalimumab (38.5%) groups, respectively. Peripheral blood immunophenotyping showed that the proportion of activated T helper (Th) 1 cells was significantly lower in patients with PAO than in healthy controls and that the proportion of activated Th17 cells was significantly higher in patients with PAO, which significantly decreased after treatment with guselkumab.
CONCLUSION
Although guselkumab and adalimumab have comparable efficacy for PAO, their impact on immunophenotypes varies.
Topics: Humans; Adalimumab; Osteitis; Psoriasis; Immunophenotyping; Arthritis
PubMed: 36303202
DOI: 10.1186/s13075-022-02934-3 -
Nature Communications Jun 2023Biologics are increasingly used to treat Vogt-Koyanagi-Harada disease, but head-to-head comparisons with conventional immunosuppressants are lacking. Here in this... (Randomized Controlled Trial)
Randomized Controlled Trial
Biologics are increasingly used to treat Vogt-Koyanagi-Harada disease, but head-to-head comparisons with conventional immunosuppressants are lacking. Here in this randomized trial (Chinese Clinical Trial Registry, ChiCTR2100043061), we assigned 110 patients (27 early-phase and 83 late-phase) to cyclosporine-based immunosuppressant strategy (N = 56) or adalimumab-based biologic strategy (N = 54), each combined with a modified corticosteroid regimen. The primary outcome is change from baseline in best-corrected visual acuity at week 26. The margin of non-inferiority for cyclosporine is -7 letters. The primary outcome is 11.2 letters (95% CI, 7.5 to 14.9) in the cyclosporine group and 6.3 letters (95% CI, 3.1 to 9.6) in the adalimumab group (difference, 4.9; 95% CI, 0.2 to 9.5; P < 0.001 for non-inferiority). The between-group difference is -0.8 letters (95% CI, -6.1 to 4.5) in early-phase disease and 5.7 letters (95% CI, 0.2 to 11.2) in late-phase. Serious adverse events are reported less frequently in the cyclosporine group than in the adalimumab group (0.70 vs. 1.21 events per patient-year). Here, we report that combined with a non-standard corticosteroid regimen, cyclosporine-based immunosuppressant strategy is non-inferior to adalimumab-based biologic strategy by 26 weeks for visual improvement in a cohort of patients with Vogt-Koyanagi-Harada disease, 75% of whom have a late-phase disease.
Topics: Humans; Immunosuppressive Agents; Uveomeningoencephalitic Syndrome; Adalimumab; Cyclosporine; Biological Products
PubMed: 37355662
DOI: 10.1038/s41467-023-39483-5 -
Journal of Neurology Apr 2022Tumor necrosis factor (TNF) alpha is critical in the development of granulomas and multiple recent reports have highlighted the role of infliximab, an infused TNF alpha... (Review)
Review
BACKGROUND
Tumor necrosis factor (TNF) alpha is critical in the development of granulomas and multiple recent reports have highlighted the role of infliximab, an infused TNF alpha inhibitor, in the treatment of neurosarcoidosis. As a self-injected TNF alpha inhibitor, adalimumab has certain advantages over infused medications, including greater patient freedom and autonomy. Experience with adalimumab is not well reported in the literature.
OBJECTIVE
To report clinical experience with adalimumab in the treatment of central nervous system (CNS) sarcoidosis by combining observations in our center with those that have been reported in the literature.
METHODS
Patients were identified from the Mass General Brigham Research Patient Data Registry and in the literature by searching PubMed. Patients with CNS manifestations of sarcoidosis treated with adalimumab were included for retrospective review and analyzed for baseline characteristics, treatment indications, outcomes, and adverse effects.
RESULTS
Adalimumab was commonly started after failure of or intolerance to infliximab and methotrexate. Of those with adequate follow-up, 5/10 ultimately improved, remission was maintained in 3/10, and 2/10 with active disease remained stable without further worsening. One patient suffered a relapse, likely multifactorial in etiology, but has remained relapse free on adalimumab for 10 months subsequently. Three patients ultimately discontinued adalimumab.
CONCLUSIONS
Preliminary evidence suggests that adalimumab may be a reasonable therapeutic option for patients with neurosarcoidosis affecting the CNS, including those with medically refractory disease.
Topics: Adalimumab; Central Nervous System; Central Nervous System Diseases; Humans; Infliximab; Sarcoidosis; Tumor Necrosis Factor-alpha
PubMed: 34487233
DOI: 10.1007/s00415-021-10793-2 -
Microbial Pathogenesis Jan 2022Psoriasis is an inflammatory immune-mediated skin disease that significantly impacts physical and psychological well-being. Adalimumab (ADA), a tumor necrosis factor...
Psoriasis is an inflammatory immune-mediated skin disease that significantly impacts physical and psychological well-being. Adalimumab (ADA), a tumor necrosis factor (TNF)-α antagonist, is used to treat psoriasis. This study was performed to assess the efficacy and safety of ADA, identify the fecal microbial composition of psoriasis patients, and explore the effect of ADA on the gut bacteria in psoriasis. Clinical characteristics of the 13 psoriasis patients before (BT) and after ADA treatment (AT) were collected. And total 39 fecal samples from 13 psoriasis patients (BT and AT) and 13 healthy controls were sequenced by 16S rRNA and analyzed by informatics methods. After three months' ADA treatment, physician global assessment (PGA), psoriasis area and severity index (PASI), dermatology life quality index (DLQI), state-trait anxiety inventory (STAI), and itch numeric rating scale (NRS) scores all decreased, and there were no severe adverse effects. Besides, the microbiota of the psoriasis group differed from that of the healthy group, but no microbial diversity and composition alteration were observed between psoriasis patients BT and AT. We suggested that the gut microbiome may change more slowly than skin lesions. Long-term follow-up of patients treated with ADA and further study of psoriasis based on microbiota may provide more evidence for the treatment of psoriasis.
Topics: Adalimumab; Gastrointestinal Microbiome; Humans; Psoriasis; RNA, Ribosomal, 16S; Severity of Illness Index; Treatment Outcome; Tumor Necrosis Factor-alpha
PubMed: 34843923
DOI: 10.1016/j.micpath.2021.105308 -
Inflammopharmacology Jun 2023Psoriasis represents an immune-mediated disease with an unclear cause that's marked by inflammation triggered by dysfunction in the immune system, which results in... (Review)
Review
Psoriasis represents an immune-mediated disease with an unclear cause that's marked by inflammation triggered by dysfunction in the immune system, which results in inflammation in various parts of the skin. There could be obvious symptoms, such as elevated plaques; these plaques may appear differently depending on the type of skin. This disease can cause inflammation in the elbows, lower back, scalp, knees, or other regions of the body. It can begin at any age, although it most commonly affects individuals between the ages of 50 and 60. Specific cells (such as T cells) have been observed to play an obvious role in the pathogenesis of psoriasis, in addition to specific immunological molecules such as TNF-, IL-12, IL-23, IL-17, and other molecules that can aid in the pathogenesis of psoriasis. So, during the past two decades, biologists have created chemical drugs that target these cells or molecules and therefore prevent the disease from occurring. Alefacept, efalizumab, Adalimumab, Ustekinumab, and Secukinumab are a few examples of chemical drugs. It was discovered that these chemical drugs have long-term side effects that can cause defects in the patient's body, such as the development of the rare but life-threatening disorder progressive multifocal leukoencephalopathy (PCL). Its rapidly progressive infection of the central nervous system caused by the JC virus and other drugs may cause increased production of neutralising anti-drug antibodies (ADA) and the risk of infusion reactions like pruritus, flushing, hypertension, headache, and rash. So, our context intends to talk in our review about natural products or plants that may have therapeutic characteristics for this disease and may have few or no side effects on the patient's body.
Topics: Humans; Middle Aged; Antibodies, Monoclonal; Psoriasis; Adalimumab; Interleukin-12; Inflammation
PubMed: 36995575
DOI: 10.1007/s10787-023-01178-0 -
Immunological Medicine Sep 2019Uveitis is an ocular disease associated with systemic immune-mediated diseases such as rheumatoid arthritis, inflammatory bowel disease and ankylosing spondylitis; and... (Review)
Review
Uveitis is an ocular disease associated with systemic immune-mediated diseases such as rheumatoid arthritis, inflammatory bowel disease and ankylosing spondylitis; and infectious diseases. Infectious uveitis occasionally shows symptoms similar to those of non-infectious uveitis. Therefore, distinguishing between non-infectious and infectious uveitis is critical for definitive diagnosis and appropriate choice of treatment. Once the cause of infection is known, treatment can be promptly initiated. However, in contrast to infectious uveitis, non-infectious uveitis is more difficult to diagnose clinically. Eliminating the possibility of infectious uveitis is important because unlike the infectious type, non-infectious uveitis is treated with immunosuppressive drugs such as corticosteroids and biological agents. Compared to other countries, the drugs available in Japan are limited. Cyclosporin A is the only immunosuppressive drug available for treating uveitis in Japan, and infliximab and adalimumab are the only biological drugs that have been approved for use in the treatment of uveitis in Japan. In this review, I describe the characteristics of typical non-infectious uveitis in Japan and its treatment methods.
Topics: Adalimumab; Cyclosporine; Humans; Immunosuppressive Agents; Infliximab; Japan; Uveitis
PubMed: 31645201
DOI: 10.1080/25785826.2019.1678961