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Search results for: Tofacitinib

FDA Update: New Drug Approvals, New & Expanded Indications, & More

Susan Bernstein  |  March 12, 2020

ATLANTA—New drug approvals, new and expanded drug indications, and important safety and other updates relevant for rheumatologists were presented by three physicians from the U.S. Food & Drug Administration (FDA) on Nov. 11 at the 2019 ACR/ARP Annual Meeting. New JAK Inhibitor Approved for RA On Aug. 16, 2019, the FDA approved upadacitinib (Rinvoq), an…

Filed under:Biologics/DMARDsDrug UpdatesMeeting Reports Tagged with:2019 ACR/ARP Annual MeetingapremilastCertolizumab PegolFebuxostatixekizumabJAK inhibitorsnintedanibrituximabU.S. Food and Drug Administration (FDA)upadacitinib

FDA Rheumatology Update: New Drug Approvals, Plus Expanded Drug Indications & Safety Concerns

Susan Bernstein  |  February 12, 2020

Last year, the FDA was busy with new biologic and other drug approvals, new and expanded drug indications, and important safety updates relevant to rheumatology…

Filed under:Drug Updates Tagged with:2019 ACR/ARP Annual MeetingBiologicsFDAU.S. Food and Drug Administration (FDA)

New Options for Treatment-Resistant RA

Carina Stanton  |  October 14, 2019

Two JAK inhibitors, one recently approved by the FDA, have shown improvements in patients with active RA for whom other therapies have proved ineffective…

Filed under:ConditionsRheumatoid Arthritis Tagged with:drug treatmentfilgotinibRheumatoid Arthritis (RA)upadacitinib

Updates to Axial Spondyloarthritis Guideline

Carina Stanton  |  September 5, 2019

A 2019 update of the ACR’s previous clinical practice guideline on axial spondyloarthritis is now available online. Lead investigator Michael Ward, MD, shares advice for implementing the guideline updates, including those related to sequencing and tapering biologics, and knowing when to obtain images.

Filed under:Axial SpondyloarthritisClinical Criteria/Guidelines Tagged with:Ankylosing SpondylitisAS Resource Centeraxial spondyloarthritis (SpA)Clinical GuidelinesMichael Ward

FDA Approves AbbVie’s New Rheumatoid Arthritis Drug

Reuters Staff  |  August 19, 2019

(Reuters)—The U.S. Food and Drug Administration (FDA) on Friday approved AbbVie Inc.’s new treatment for rheumatoid arthritis (RA), a win for the drugmaker seeking to widen its portfolio as its blockbuster flagship therapy Humira (adalimumab)‎‎ faces competition. The drug, Rinvoq (upadacitinib), is a JAK inhibitor. It is set to compete with Pfizer Inc.’s Xeljanz (tofacitinib)…

Filed under:Drug Updates Tagged with:AbbVieFDAFDA approvalRheumatoid Arthritis (RA)U.S. Food and Drug Administration (FDA)upadacitinib

Otilimab Begins Phase 3 Clinical Studies for RA

Michele B. Kaufman, PharmD, BCGP  |  August 19, 2019

In a four-part clinical trial program, researchers are assessing the safety and efficacy of otilimab with placebo in RA patients, along side conventional treatments, such as tofacitinib, and DMARDs…

Filed under:Drug Updates Tagged with:biologic DMARDsotilimabRheumatoid Arthritis (RA)sarilumab

Lessons Learned from Two Scleroderma Lung Studies (Plus a Third That’s Recruiting Sites)

Elizabeth R. Volkmann, MD, MS, Michael D. Roth, MD, Donald P. Tashkin, MD, Cathie Spino, ScD, & Dinesh Khanna, MD, MS  |  August 16, 2019

Historically, the early approach for treating interstitial lung disease (ILD) due to systemic sclerosis (SSc) involved immunosuppressant therapy, primarily with cytotoxic agents.1 Glucocorticoids in combination with another immunosuppressant agent, such as oral azathioprine or cyclophosphamide, were often used to treat patients with severe, progressive SSc-ILD.2 However, direct evidence to support this thera­peutic approach was lacking…

Filed under:ConditionsSystemic Sclerosis Tagged with:cyclophosphamideInterstitial Lung Diseasemycophenolate mofetilpirfenidonesystemic sclerosis (SSc)

Rheumatology Drugs at a Glance, Part 3: Rheumatoid Arthritis

Mary Choy, PharmD, BCGP, FASHP  |  August 16, 2019

Over the past few years, bio­similars and other new drugs have been introduced to treat rheumatic illnesses. Some of the conditions we treat have numerous drug options, others have few or only off-label options. This series, “Rheumatology Drugs at a Glance,” provides streamlined information on the administration of biologic, biosimilar and small molecule inhibitor drugs…

Filed under:ConditionsDrug UpdatesRheumatoid Arthritis Tagged with:abataceptadalimumabanakinrabaricitinibCertolizumab PegoletanerceptGolimumabinfliximabrituximabsarilumabtocilizumabTofacitinib

Myositis Autoantibodies as Biomarkers

Lara C. Pullen, PhD  |  June 4, 2019

A recent study details the autoantibodies of patients with myositis, confirming most patients carry these antibodies. The results also describe how myositis-specific autoantibodies can be used to identify distinct clinical subsets of idiopathic inflammatory myopathy…

Filed under:ConditionsMyositis Tagged with:autoantibodiesidiopathic inflammatory myopathiesILDInterstitial Lung Diseasemyositis

Upadacitinib Monotherapy Effective in Refractory Rheumatoid Arthritis

Will Boggs MD  |  May 30, 2019

NEW YORK (Reuters Health)—Monotherapy with the JAK1-selective inhibitor upadacitinib is effective in patients with active rheumatoid arthritis who have an inadequate response to methotrexate, according to results from the SELECT-MONOTHERAPY phase 3 trial. As many as two-thirds of patients with rheumatoid arthritis receiving methotrexate monotherapy fail to achieve satisfactory disease control. Oral therapy with upadacitinib…

Filed under:Drug UpdatesRheumatoid Arthritis Tagged with:AbbVieCharles J. MalemudJosef S. SmolenMethotrexateupadacitinib monotherapy

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