Rheumatology

Original New Drug Application Approvals by US FDA (16 - 30 November 2022)

Yesterday

New drug applications approved by US FDA as of 16 - 30 November 2022 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Total ankle replacement vs arthrodesis: Which is better for ankle osteoarthritis?

5 days ago

Total ankle replacement (TAR) and ankle fusion (AF) or arthrodesis both improve the Manchester–Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores in patients with end-stage ankle osteoarthritis at 52 weeks after surgery, reports a study. The two surgical treatments also show similar clinical scores and number of harms.

Contrast-enhanced ultrasonography detects carotid artery inflammation in Takayasu arteritis

25 Nov 2022

Follow-up monitoring of the carotid artery with contrast-enhanced ultrasonography (CEUS) identifies response or relapse in most patients with Takayasu arteritis (TAK), reports a study.

Fatigue worsens quality of life, productivity in patients with psoriatic arthritis

Stephen Padilla, 25 Nov 2022

Patients with psoriatic arthritis (PsA) usually complain of fatigue, which is less frequently diagnosed by many physicians, reports a study. Severe fatigue may lead to poorer physical functioning, work productivity, and health-related quality of life (HRQOL).

Anifrolumab for SLE shows favourable benefit–risk profile in extension study

22 Nov 2022

Patients with moderate-to-severe systemic lupus erythematosus (SLE) appear to fare well with anifrolumab, with a recent study showing that the drug has an acceptable long-term safety profile and helps maintain reductions in disease activity and glucocorticoid usage.

Deucravacitinib bestows benefits in Asian patients with plaque psoriasis

Roshini Claire Anthony, 04 Oct 2022

The benefit of deucravacitinib in moderate to severe plaque psoriasis was demonstrated in a population of Asian patients, according to results of the phase III POETYK PSO-3 trial.

Baricitinib delays, lowers frequency of flares in JIA

Roshini Claire Anthony, 23 Jun 2022

In patients with juvenile idiopathic arthritis (JIA) with insufficient response to conventional synthetic (cs) or biologic (b) disease-modifying antirheumatic drugs (DMARDs), the JAK*1/2 selective inhibitor baricitinib reduced the frequency and delayed time to disease flares, according to a phase III trial presented at EULAR 2022.

Bimekizumab triumphs in bDMARD-naïve psoriatic arthritis patients

Roshini Claire Anthony, 20 Jun 2022

Patients with psoriatic arthritis (PsA) with no prior exposure to biological disease-modifying antirheumatic drugs (bDMARDs) experience improvements in their condition when treated with bimekizumab, according to results of the phase III BE OPTIMAL trial.

Bimekizumab shows promise across the spectrum of axial spondyloarthritis

Elaine Soliven, 18 Jun 2022

Treatment with bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, significantly improved ASAS40* response rate in patients with either nonradiographic axial spondyloarthritis (nr-axSpA) or ankylosing spondylitis (AS**), according to two phase III studies presented at EULAR 2022.

JAK inhibition with upadacitinib works well in nr-axSpA

Elvira Manzano, 16 Jun 2022

Treatment with upadacitinib improves disease activity, pain, function, and quality of life (QoL) in patients with non-radiographic axial spondyloarthritis (nr-axSpA) in a study touted as the first to evaluate a Janus kinase (JAK) inhibitor for this condition.

Sarilumab shows potential for relapsing polymyalgia rheumatica

Audrey Abella, 15 Jun 2022

The monoclonal antibody sarilumab demonstrated significant efficacy in individuals with relapsing polymyalgia rheumatica (PMR), findings from the phase III SAPHYR trial have shown.