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Search results for: guselkumab

FDA Approval Sought for 2 Pediatric Indications for Guselkumab

Michele B. Kaufman, PharmD, BCGP  |  February 11, 2025

The FDA is reviewing supplemental biologics license applications for guselkumab to treat children with juvenile psoriatic arthritis and moderate to severe plaque psoriasis.

Filed under:Biologics/DMARDsConditionsDrug UpdatesPsoriatic Arthritis Tagged with:FDA approvalguselkumabjuvenile idiopathic arthritis (JIA)pediatric plaque psoriasis

New Data Highlight Effectiveness of Guselkumab for Patients with PsA

Michele B. Kaufman, PharmD, BCGP  |  February 2, 2022

The use of guselkumab improved joint and skin symptoms in biologic naive patients with PsA, according to research presented during ACR Convergence 2021.

Filed under:ACR ConvergenceDrug UpdatesMeeting Reports Tagged with:ACR Convergence 2021guselkumabPsAPsoriatic Arthritis

Guselkumab Boosts Response in Resistant Psoriatic Arthritis

Marilynn Larkin  |  December 3, 2021

NEW YORK (Reuters Health)—In patients with psoriatic arthritis (PsA) who are resistant to tumor necrosis factor inhibitors (TNFi), guselkumab was more effective than placebo in a phase 3b trial. “Guselkumab is a relatively new treatment and is the first drug in its class (IL-23 inhibitor) to gain approval for PsA,” Dr. Laura Coates of the…

Filed under:Conditions

Guselkumab Promising in Patients with PsA

Michele B. Kaufman, PharmD, BCGP  |  October 7, 2021

Initial 24-week data from a study of patients with psoriatic arthritis (PsA) show that treatment with guselkumab improved symptoms and resulted in a higher ACR20 response than placebo in patients who could not tolerate, or did not respond to, treatment with a tumor necrosis factor inhibitor (TNFi).

Filed under:Biologics/DMARDsConditionsDrug UpdatesEULAR/OtherMeeting ReportsPsoriatic Arthritis Tagged with:EULARguselkumabPsoriatic Arthritis

Guselkumab Promising for Psoriatic Arthritis with Axial Symptoms

Lorraine L. Janeczko  |  July 17, 2021

NEW YORK (Reuters Health)—Guselkumab may be effective in patients who have psoriatic arthritis (PsA) with axial symptoms, a post-hoc analysis of data from two randomized controlled trials suggests.1 “Because PsA is a heterogeneous disease that manifests as various symptoms, treatment choices should involve consideration of all relevant domains of disease for each individual patient,” researchers…

Filed under:ConditionsDrug UpdatesPsoriatic Arthritis Tagged with:Drug UpdatesguselkumabPsoriatic Arthritis

Guselkumab Promising to Slow Joint Damage in Patients with Psoriatic Arthritis

Michele B. Kaufman, PharmD, BCGP  |  June 29, 2021

In an efficacy and safety study of guselkumab, patients with active psoriatic arthritis taking guselkumab showed continued skin clearance and joint symptom relief, as well as statistically significant inhibition of joint damage, after two years.

Filed under:ConditionsDrug UpdatesPsoriatic Arthritis Tagged with:Psoriatic Arthritis

Guselkumab Approved for PsA

Michele B. Kaufman, PharmD, BCGP  |  August 6, 2020

Based on data from two clinical trials, the FDA has approved guselkumab to treat adult patients with active psoriatic arthritis…

Filed under:Drug Updates Tagged with:FDAFDA approvalguselkumabPsoriatic ArthritisU.S. Food and Drug Administration (FDA)

FDA Approves Tremfya (Guselkumab) for Adult Patients with Psoriatic Arthritis

Natasha Yetman  |  July 15, 2020

HORSHAM, PA—The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.1,2 Tremfya is the first treatment approved for active PsA that selectively inhibits interleukin (IL)…

Filed under:Biologics/DMARDsDrug Updates Tagged with:FDA approvalguselkumabU.S. Food and Drug Administration (FDA)

FDA Approves Guselkumab Injector

Michele B. Kaufman, PharmD, BCGP  |  March 20, 2019

The FDA has approved a single-press, self-injection device for a 100-mg dose of guselkumab for adults with moderate to severe plaque psoriasis…

Filed under:Biologics/DMARDsDrug Updates

Guselkumab May Best Adalimumab for Psoriasis on the Scalp, Palms & Soles

Marilynn Larkin  |  May 29, 2018

NEW YORK (Reuters Health)—The interleukin 23 inhibitor guselkumab is associated with more improvement in psoriasis on the scalp, palms and/or soles compared with adalimumab, a new analysis suggests. Andrew Blauvelt, MD, MBA, of Oregon Medical Research Center in Portland conducted a secondary analysis of data from the international VOYAGE 1 and VOYAGE 2 studies, double-blind,…

Filed under:Biologics/DMARDsDrug Updates Tagged with:adalimumabfeetguselkumabhandPsoriasisscalp

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