adalimumab (Handayuan / Handafar / adalimumab, Henlius)

Prescription Pattern and Safety of Biologics in Autoimmune Rheumatologic Diseases in Tertiary Care Hospital of Bihar.

Shakur Adil Ali AA, Kumar Raj R, Ranjan Raushan Kumar RK, Hameed Saajid S et al.

Biologics have revolutionized the treatment of autoimmune rheumatologic diseases, but data on their real-world use and safety in resource-limited settings like Bihar, India, are scarce. This study aimed to evaluate the prescription patterns and safety profile of biologic disease-modifying antirheumatic drugs (b-DMARDs) in patients with rheumatoid arthritis (RA) at a tertiary care hospital in Bihar. A prospective, observational cohort study conducted over 12 months. A total of 120 adult patients with RA prescribed b-DMARDs were enrolled. Data on demographic, clinical characteristics, and treatment details were collected. Disease activity (DAS-28-CRP) and functional status (HAQ-DI) were assessed at baseline and 6 months. Adverse events, particularly infections, were recorded and analysed using multivariable logistic regression to identify risk factors. Biologicals were prescribed in 14.93% patients with RA. Adalimumab (49.17%) was the most prescribed b-DMARD, followed by etanercept (28.33%). Methotrexate was the most common concomitant conventional DMARD (85.83%). All b-DMARDs significantly improved DAS-28-CRP and HAQ-DI scores (P < .0001), with adalimumab showing the greatest improvement. Infliximab had the highest infection rate (53.33%), whereas etanercept had the lowest (14.70%). Regression analysis identified infliximab use (adjusted odds ratio [aOR]: 3.27), concomitant corticosteroid use (aOR: 2.74), and the presence of comorbidities (aOR: 2.13) as significant independent risk factors for infection. Biologic disease-modifying antirheumatic drugs are effective in RA, but infection risks vary. Adalimumab and etanercept demonstrated favourable efficacy and safety profiles, respectively. Treatment decisions should be personalized, considering drug-specific risks, corticosteroid co-therapy, and patient comorbidities, especially in resource-constrained settings.

Anti-TNF Drug-Induced Sarcoidosis in Inflammatory Bowel Diseases: Multicentric Case Series and Literature Review.

Bez Patrick P, Chkolnaia Zlata Z, Aratari Annalisa A, Ascolani Marta M et al.

Sarcoidosis is an inflammatory granulomatous condition and presents overlapping features with inflammatory bowel disease (IBD). Anti-TNF treatment has revolutionized the management of several conditions, including IBD and sarcoidosis. Yet, anti-TNF drugs have been associated with drug-induced sarcoidosis reaction (DISR). This is a retrospective, international, multicentric case series, including IBD patients with anti-TNF-related DISR. A literature review was performed to identify previously published cases. Nine new cases of anti-TNF-related DISR in IBD are described with a long follow-up (median 45 months). After literature review, a total of 26 cases were identified. The diagnosis required histological evidence of granulomas in involved organs in all patients. Most patients had a diagnosis of Crohn's disease (n = 19, 73.1%). The culprit drug was infliximab in 15 (57.7%) and adalimumab in 11 (42.3%). The median time to sarcoidosis development was 21 months. Compared to conventional sarcoidosis, extrathoracic involvement was more prevalent (n = 20, 76.7%). Management of DISR consisted of discontinuing anti-TNF treatment in 20 cases (76.9%) and providing specific treatment in 17 cases (65.4%), with favorable outcomes in all cases. Despite its rarity, DISR may be challenging for IBD patients. Discontinuation of anti-TNF treatment is recommended, and specific treatment is required for moderate-to-severe cases.

Unveiling Genital Crohn's Disease: Clinical Complications, Diagnosis, and Treatment, a Comprehensive Review of Case Reports.

Fahim Bishoy B, Elnaggar Mohamed M, Ebrahim Mohamed Ayman MA, Sapoor Shady S et al.

Genital Crohn's disease (GCD) is an infrequent extraintestinal manifestation of Crohn's disease characterized by ulceration, pain, edema, and erythema in the anogenital area. GCD poses significant diagnostic and management challenges, mainly because there are no standardized clinical protocols. This review analyzed 20 case reports and series from 1983 to 2024, focusing on patients with GCD. The databases used for this search were PubMed, Scopus, and Google Scholar. The most common presentation in male patients was genital edema or swelling, seen in 88.9% of cases. Pain was the main presentation in 71.9% of cases among female patients. Several complications were reported, including rectovaginal and enterovaginal fistulas, tubo-ovarian abscesses, and penile involvement. The diagnosis was made based on clinical evaluation, which was supported by laboratory tests, physical examinations, imaging, and endoscopic procedures. Histological examinations of biopsied genital ulcers demonstrated non-caseating granulomatous inflammation; however, this finding was observed in only 50% of patients. Moreover, pelvic magnetic resonance imaging is highlighted as a crucial diagnostic tool. The most common form of treatment is pharmacological therapy. Corticosteroids, immunosuppressants, and tumor necrosis factor-alpha inhibitors are the most frequently used drugs. A total of 14 studies reported that corticosteroids administered via intravenous and oral routes resulted in a notable reduction in disease severity. The tumor necrosis factor-alpha inhibitors adalimumab and infliximab showed notable efficacy. New therapies such as carbon laser therapy and autologous stem cell transplantation showed promising outcomes in refractory cases. Surgical procedures are reserved for refractory or complicated cases. This review highlights that medical management with corticosteroids, immunomodulators, and biologics remains the cornerstone of treatment for GCD, with surgery playing a role in refractory disease.

Tuberculosis prophylaxis and long-term safety in adalimumab biosimilar therapy: The need for strengthened vigilance.

C S Chaitra C, Nevil Shaun S, Charles S Anton SA