Refractory Acne in SAPHO Syndrome Rapid Resolution Following Adalimumab Therapy.
Xu Cheng C, Ouyang Mingli M, Han Yongmei Y
Zhejiang Hisun Pharmaceutical Co., Ltd. · TNF · Monoclonal Antibodies
adalimumab is a monoclonal antibodies developed by Zhejiang Hisun Pharmaceutical Co., Ltd.. It is approved for therapeutic indications via injectable (others) or intravenous (iv) or subcutaneous injection.
| Brand Names | HS 016, Anjianning, HS016 |
| Company | Zhejiang Hisun Pharmaceutical Co., Ltd. |
| Drug Class | Monoclonal Antibodies, Antibody |
| Molecular Target | TNF |
| Route | Injectable (Others), Intravenous (IV), Subcutaneous Injection |
| Status | Approved |
adalimumab acts on 1 molecular target:
| TNF | tumor necrosis factor (TNFA, TNF-alpha) |
adalimumab is developed for 10 unique indications across 4 therapeutic areas.
| Therapeutic Area | Condition | Phase |
|---|---|---|
| Musculoskeletal and connective tissue disorders | Ankylosing spondylitis | ✓ Approved |
| Skin and subcutaneous tissue disorders | Psoriasis | ✓ Approved |
| Musculoskeletal and connective tissue disorders | Rheumatoid arthritis | ✓ Approved |
| Gastrointestinal disorders | Colitis ulcerative | Phase I |
| Gastrointestinal disorders | Crohn's disease | Phase I |
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Miedziaszczyk Miłosz M, Kosiorowski Gracjan G, Kubasik Janusz J, Grabowski Tomasz T et al.
The use of monoclonal antibodies (mAbs) has revolutionized the treatment of autoimmune, inflammatory, and neoplastic diseases. However, accumulating evidence indicates that biologic therapies may be associated with renal adverse events, including various types of glomerulonephritis. The aim of this review was to summarize all reports available in the scientific literature regarding the occurrence of IgA nephropathy after monoclonal antibody treatment. Additionally, the risk of other glomerulonephritis after biologic therapy was discussed. IgA nephropathy (IgAN) is the most commonly reported glomerular lesion associated with monoclonal antibody therapy, particularly with TNF-α inhibitors such as infliximab, adalimumab, golimumab, and etanercept, as well as with immune checkpoint inhibitors targeting the PD-1 (pembrolizumab, nivolumab) and interleukin (ustekinumab) pathways. Proposed mechanisms include immune dysregulation with a shift toward Th2 and Th17-dependent responses, increased production of galactose-deficient IgA1, complement activation, formation of circulating immune complexes, and loss of immune tolerance. In some cases, drug discontinuation and glucocorticoid therapy have resulted in partial or complete disease remission, although progression to end-stage renal disease has also been reported. Due to the potential severity of these complications, initial and periodic monitoring of renal function and urinalysis are recommended in patients receiving monoclonal antibody therapy. Early recognition of renal involvement and prompt treatment modification can improve prognosis.
Chen Kai-Yang KY, Chan Hoi-Chun HC, Chan Chi-Ming CM
Non-infectious uveitis (NIU) is a chronic immune-mediated ocular inflammatory disease that may cause irreversible visual impairment. The comparative efficacy and safety of systemic immunomodulatory therapies, including conventional agents and biologics, remain incompletely defined. This systematic review and network meta-analysis evaluated systemic immunosuppressive therapies for NIU. PubMed/MEDLINE, Cochrane CENTRAL, Scopus and Web of Science Core Collection were searched from inception to May 2, 2026. Randomized controlled trials and prospective comparative cohort studies evaluating systemic immunomodulatory or biologic therapies for NIU were included. The primary efficacy outcome was treatment failure. Safety outcomes included mortality, urinary tract infection, upper respiratory tract infection, injection-site reactions, ocular hypertension, macular edema, and headache. Random-effects pairwise meta-analysis and frequentist network meta-analysis were performed using risk ratios (RRs) with 95% confidence intervals (CIs). Seven studies including 992 participants were included; six were randomized controlled trials and one was a prospective cohort. In the pairwise meta-analysis, adalimumab significantly reduced treatment failure compared with placebo (RR, 0.67; 95% CI, 0.58-0.78; p < 0.0001; I² = 28.1%). The mortality estimate was inconclusive (RR, 3.80; 95% CI, 0.42-34.15), with three deaths in the adalimumab groups and none in the placebo groups. Adalimumab was associated with a higher risk of injection-site reactions than placebo (RR, 2.67; 95% CI, 1.73-4.12). Network meta-analysis showed no significant differences for most safety outcomes, including upper respiratory tract infection, ocular hypertension, macular edema, and headache. Infliximab showed an imprecise urinary tract infection signal versus placebo (RR, 40.98; 95% CI, 1.82-922.17), based on sparse events and one nonrandomized comparison. Adalimumab provides the most consistent evidence for reducing treatment failure in NIU. Comparative safety estimates, particularly for infliximab, remain uncertain and hypothesis-generating. Larger, long-term, head-to-head trials are required.
Hashizumi Shunki S, Kagoyama Ko K, Ishida Hiroaki H, Makino Teruhiko T et al.
Treatment of extensive multiregional hidradenitis suppurativa requires sequencing biologic therapy and surgery when active inflammation and irreversible structural disease coexist. A 58-year-old Japanese man with Hurley Stage III disease had inadequate overall control with adalimumab. At the assessment before medial-thigh surgery, the International Hidradenitis Suppurativa Severity Score System score was 48. Because he sought prompt relief from painful drainage and daily wound care, bilateral scarred and tunnel-bearing lesions were excised and reconstructed by staged split-thickness skin grafting while adalimumab was continued. Local control was achieved, but disease persisted elsewhere, prompting a switch to bimekizumab. Inflammatory lesion counts decreased, but Hidradenitis Suppurativa Clinical Response was not achieved at week 16 and extensive gluteal scars and draining tunnels remained. Bilateral gluteal excision and staged grafting were therefore performed during continued bimekizumab treatment, without postoperative infection, bleeding, or graft failure. Six months after reconstruction, the severity score was 9 and the clinical response criterion was met, reflecting both decreased inflammatory activity during bimekizumab treatment and surgical removal of structural lesions. Gluteal local control persisted through 15 months. This case illustrates sequencing biologic switching and regional surgery according to inflammatory activity, persistent structural disease, and the need for prompt symptom relief.
Roland-McGowan Jaclyn J, Seervai Riyad N H RNH, Lee Claudia C, Koon Stephanie Mengden SM et al.
Hemophagocytic lymphohistiocytosis (HLH) is a rare, life-threatening hyperinflammatory syndrome most commonly triggered in adults by infection, malignancy, or autoimmune disease. Disseminated histoplasmosis is an uncommon but recognized infectious trigger, particularly in immunosuppressed patients. Its cutaneous manifestations may be subtle and nonspecific but can provide accessible tissue for diagnostic evaluation. A 41-year-old man with psoriasis treated with adalimumab presented with 5 months of progressive constitutional and abdominal symptoms followed by fever, shock, pancytopenia, hepatosplenomegaly, coagulopathy, hypertriglyceridemia, and extreme hyperferritinemia (> 89,000 ng/mL). Bone marrow biopsy demonstrated hemophagocytosis but was negative for fungal organisms on Grocott methenamine silver staining. Punch biopsy of scattered pink-to-violaceous acneiform papules on the forehead and scalp demonstrated numerous tissue-invasive microorganisms, and subsequent molecular testing identified Histoplasma capsulatum. He received dexamethasone, ruxolitinib, and liposomal amphotericin B; etoposide was withheld because of ongoing hemorrhage. Despite treatment, he succumbed to hemorrhagic shock and multiorgan failure and died. Autopsy demonstrated widespread histoplasmosis. In patients with HLH, subtle skin lesions may provide accessible tissue for demonstrating invasive infection and obtaining organism-specific confirmation, even when fungal staining of another tissue is negative. Careful skin examination and targeted biopsy of new, atypical, or evolving lesions should be considered in immunocompromised adults with unexplained systemic inflammation, particularly those receiving tumor necrosis factor-alpha inhibitors.
McCall Kenneth L KL, Bush Kristin T KT, George Courtney E CE, Goudy Hailey N HN et al.
Pericardial syndromes cause significant morbidity, decreased quality of life, and rarely mortality. Drug-associated pericardial syndromes are underreported. This study characterized reports of pericardial disorders, described demographic and reporting features, and identified disproportionality signals across suspect drugs and therapeutic classes. This study analyzed FDA Adverse Event Reporting System reports from January 2000 to March 2025, using predefined preferred terms for pericardial syndromes. Duplicate and pediatric reports (<18 years) were excluded, resulting in 12,106 unique reports. A lower 90% confidence limit of the Empirical Bayes Geometric Mean (EB05)>2 and a lower limit of the 95% credibility interval of the Information Component (IC025)>0 were indicators of signals. Raw counts of reports increased from 133 in 2000 to 939 in 2024. The cohort had a balanced sex distribution and a mean age of 55.5 years. Among females, antineoplastic (e.g., rituximab, EB05 = 13.3, IC025 = 3.7) and immunomodulating agents (e.g., adalimumab, EB05 = 3.1, IC025 = 1.6) were most frequently suspected. Among males, antithrombotic agents (e.g., aspirin, EB05 = 7.1, IC025 = 2.8) predominated. A higher age-adjusted reporting odds of death was observed in females versus males (OR=1.14, 95% CI 1.03-1.25; deaths: females n=1,030, males n=925). Raw report counts of pericardial syndromes increased over 25 years, supporting heightened vigilance for drug-induced etiologies. Sex-stratified drug rankings were exploratory and do not demonstrate drug-by-sex interactions. The results extend the existing literature by providing a broad descriptive overview of the reporting landscape for pericardial disorders within a national spontaneous reporting system. Immunomodulating, antineoplastic, and antithrombotic agents generated reporting signals involving pericardial disorders, with sex-based differences and reported drug classes and outcomes. These findings do not establish causality and warrant confirmatory studies.
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