Search Medical Journals & Research Articles

[Review] Pan American League of Associations for Rheumatology recommendations for the management of rheumatoid arthritis

The Pan American League of Associations for Rheumatology has developed evidence-based recommendations for the pharmacological management of rheumatoid arthritis in Latin America. A panel of rheumatoid arthritis experts from Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Uruguay, and Venezuela formulated clinically relevant questions in the population, intervention, comparator, outcome format. Systematic literature reviews were done following the Grading of Recommendations Assessment, Development and Evaluation method.

[Articles] Skeletal muscle effects of Janus kinase inhibition in rheumatoid arthritis (RAMUS): a single-arm, experimental medicine study

Tofacitinib treatment in patients with rheumatoid arthritis was associated with increased muscle volume after 6 months. The increase in serum creatinine associated with tofacitinib treatment might reflect increased muscle volume via a direct pharmacological effect on skeletal muscle or via reduced inflammation, or a combination. Larger studies are needed to verify our findings, demonstrate functional benefit, and determine whether they are unique to tofacitinib.

[Articles] Fetal and maternal outcome in the pregnancies of patients with systemic sclerosis and very early diagnosis of systemic sclerosis in France: a prospective study

Despite 53 (91·4%) of 58 livebirths, systemic sclerosis pregnancies were associated with higher rates of adverse pregnancy outcomes and severe postpartum haemorrhage. Disease worsened in 23 (39·7%) of 58 pregnancies, particularly during the postpartum period, especially in women with diffuse cutaneous systemic sclerosis, previous cutaneous vascular involvement, and antibodies other than anticentromere.

[Articles] Intensive biological DMARD-first strategy versus standard step-up care in psoriatic arthritis (STAMP): 1-year results from a multicentre, open-label, randomised controlled trial comparing two treat-to-target strategies

Early use of intensive treatment with secukinumab in a treat-to-target strategy did not result in statistically superior outcomes compared with a conventional step-up treat-to-target approach. By month 12, both strategies led to similar clinical improvements, with half of patients attaining ACR50, suggesting that treatment targets can be met regardless of initial therapy.

[Articles] IgG4-related disease in the Japanese population: a whole-genome sequencing study

C4 copy number variation, in addition to HLA and FCGR2B, was found to be a distinct genetic factor associated with IgG4-related disease susceptibility, illustrating the complex polygenic nature of the disease. Furthermore, the identification of PTCH1 and the long non-coding RNA LOC102724227 as Mikulicz's disease-specific susceptibility loci suggests that genetic heterogeneity might underlie the clinical diversity of IgG4-related disease, particularly with respect to the affected organs.

[News] Research in Brief

Allogeneic CD19 chimeric antigen receptor (CAR) natural killer (NK)-cell therapy might be a promising treatment option for patients with refractory systemic lupus erythematosus (SLE), according to a first-in-human, single-centre case-series by Jie Gao and colleagues. 18 adults with relapsed or refractory SLE who had received at least two prior standard systemic therapies were given daily conditioning chemotherapy (intravenous fludarabine 25 mg/m2 and intravenous cyclophosphamide 300 mg/m2) for 3–5 days before receiving one cycle of three sequential infusions of allogeneic CD19 CAR NK cells (0·75 × 109 1·5 × 109 3·0 × 109 or 4·5 × 109 cells) at intervals of 3, 5, or 7 days, according to lymphocyte recovery and pharmacokinetics.

[Correspondence] An imaging crisis in axial spondyloarthritis – Authors' reply

We thank Audai H Abudayeh and Iakiv V Fishchenko for their thoughtful contribution to this discussion. The correspondence raises two key aspects: first, the role of recent advances in MRI, such as three-dimensional gradient-echo sequences such as volume interpolated breathhold examination (VIBE), to improve sensitivity for erosions and second, the therapeutic potential of early treatment with biologics to induce structural repair. Together, these points convey a more optimistic view of MRI for early diagnosis in axial spondyloarthritis.

[Correspondence] An imaging crisis in axial spondyloarthritis

We read with great interest the Viewpoint by Torsten Diekhoff and Denis Poddubnyy on the challenges of imaging in axial spondyloarthritis.1 The authors highlight the important risk of misclassification when MRI-detected sacroiliac joint bone marrow oedema is used to diagnose axial spondyloarthritis as the high sensitivity but insufficient specificity of this finding can lead to overdiagnosis and inappropriate treatment initiation. Their cautionary perspective is timely and warranted. However, we believe that the discussion underemphasises two crucial and emerging aspects: technical advances that increase the reliability of MRI interpretation and the therapeutic implications of early imaging.

[Comment] Tofacitinib in rheumatoid sarcopenia

Sarcopenia causing loss of muscle mass and strength is relatively common in rheumatoid arthritis, with previous small studies reporting the prevalence ranging from 4·5% to 44% of people with rheumatoid arthritis, depending on the definition of sarcopenia used.1–3 In rheumatoid arthritis, sarcopenia is mediated by inflammation-driven proteolysis, reduced physical activity due to musculoskeletal inflammation and pain, and the use of sarcopenic drugs such as glucocorticoids.3 Rheumatoid sarcopenia increases the risk of fall, fractures, disability, and hospitalisation.

[Comment] Systemic sclerosis and pregnancy: advancing prospective evidence for risk stratification and postpartum care

Systemic sclerosis is a rare autoimmune connective tissue disease that is associated with vascular and fibrotic complications that can cause concerns during pregnancy.1 Data from the UK show that from 2000 to 2022 the prevalence of systemic sclerosis in pregnant women had an average annual percantage increase of 1·7%,2 probably due to improved diagnosis and management. However, this increase also highlights the need to develop a better understanding of the effect of systemic sclerosis in pregnancy.

[Comment] New clues on the pathogenesis of IgG4-related disease come from genomics

IgG4-related disease is a rare fibroinflammatory disorder usually characterised by multiorgan involvement. Several organ-specific conditions once thought to be separate entities, such as chronic sclerosing pancreatitis, Mikulicz's disease (chronic sclerosing dacryoadenitis and sialadenitis), sclerosing mediastinitis, and retroperitoneal fibrosis, are now grouped under the umbrella of IgG4-related disease because they have a common histopathological background (storiform fibrosis and dense lymphoplasmacytic infiltrates rich in IgG4-positive plasma cells) and often increased serum IgG4 concentrations.

[Editorial] EBV and SLE: causal or concurrence?

The vast majority of the population have been infected by the Epstein–Barr virus (EBV), an almost universal pathogen that persists in the body throughout an individual's life. Although innocuous to most people, an association of EBV with autoimmune diseases has been clear for some time. A new study has provided the first mechanistic evidence that EBV can stimulate autoimmunity in systemic lupus erythematosus (SLE)—by reprogramming once quiescent autoreactive B cells into activated pathogenic antigen-presenting cells.

Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices | FDA

Docket Number: FDA-2021-D-0368 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Oncology Center of Excellence The guidance is intended to help clinical investigators comply with the safety reporting requirements for investigational new drug application (IND) studies and investigational device exemption (IDE) studies. Recommendations are provided in this guidance to help investigators identify safety information that needs to be reported to sponsors and institutional review boards. Submit Comments Submit Comments Online You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written comments to: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 All written comments should be identified with this document's docket number: FDA-2021-D-0368.

Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies | FDA

Docket Number: FDA-2020-D-2099 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies. This guidance provides interpretations of terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides information on other safety reporting issues raised by sponsors. To facilitate appropriate IND safety reporting practices, this guidance also provides recommendations related to the two IND safety reporting provisions that require assessment of aggregate data. Submit Comments Submit Comments Online You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written comments to: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 All written comments should be identified with this document's docket number: FDA-2020-D-2099.

CDER Small Business & Industry Assistance (SBIA)

CDER Small Business & Industry Assistance (SBIA) A Comprehensive Resource for Information on Human Drug Development in Regulation Register for Upcoming Events | Date | Time | Event | Location | |---|---|---|---| | 4/15/2026 | 1:00 pm-2:30 pm ET | Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers | Virtual | | 4/22/2026 and 4/23/2026 | 9:00 am-5:00 pm ET | Generic Drugs Forum (GDF) 2026 | In-Person and Virtual | | 5/5/2026 | 1:00 pm-2:00 pm ET | OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration | Virtual | | 5/19/2026 and 5/20/29 | 9:00am-4:50 pm ET (Day 1) and 9:00-3:50 p.m. ET (Day 2) | Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products | In-Person and Virtual | Regulatory References, Training, and Resources Regulatory References Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more SBIA Learn Online Training Repository Search for conferences, webinars, online courses, newsletters and podcasts SBIA on LinkedIn Stay connected and receive regulatory updates and event notifications SBIA On-Demand Learning Library Browse conference and webinar recordings on YouTube Popular Topics Guidances Related to Drugs Documents representing FDA's thinking on a particular subject Drug Approvals and Databases Approvals and medications – Drugs@FDA, FDALabel, Orange Book, and more Development & Approval Process Drug applications, submissions, manufacturing, and small business help Advisory Committees Independent opinions and recommendations from outside experts on applications to market new drugs and on FDA policies Paragraph Header Contact SBIA Division of Drug Information Office of Communications 10001 New Hampshire Ave Hillandale Building, 4th Fl Silver Spring, MD 20993 For Latest Updates Follow FDA Drug Information Receive the latest drug information from the US FDA