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

Natasha Yetman  |  July 15, 2020

Tremfya was also shown to relieve patients’ pain in their soft tissue and inflammation in their fingers and toes. In a pooled analysis of DISCOVER-1 and -2 at week 24, treatment with Tremfya every 8 weeks resolved enthesitis in 50% of patients vs. 29% in patients receiving placebo (P=0.0301). In another pooled analysis at week 24, treatment with Tremfya every 8 weeks also resolved dactylitis in 59% of patients vs. 42% receiving placebo (P=0.0301).

Beyond its impact on improving symptoms of PsA in joints, among patients with psoriatic skin involvement, Tremfya also resulted in an improvement in the skin manifestations of psoriasis in patients with PsA.

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“Finding the right psoriatic arthritis treatment can be hard. Individuals living with this complex disease are often left searching for answers, so it’s important for patients to understand their options and to work closely with their doctor on a treatment plan,” says Stacie Bell, Ph.D., chief scientific and medical officer, National Psoriasis Foundation. “Approval of new treatments for psoriatic arthritis is welcome news for this community and offers physicians and patients more options in their fight to manage this chronic disease.”

Patients may self-inject with the Tremfya One-Press injector after physician approval and proper training. The Tremfya One-Press is a single-dose, patient-controlled injector that has received the Arthritis Foundation’s Ease of Use Commendation after being tested in patients with PsA.

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For more information on the safety, prescribing and use of Tremfya (guselkumab), visit www.tremfya.com.

Disclaimer: Dr. Philip J. Mease is a paid consultant for Janssen. He has not been compensated for any media work.


References

  1. Belasco J, Wei N. Psoriatic arthritis: What is happening at the joint? Rheumatol Ther. 2019 Sep;6(3):305–315.
  2. McLaughlin M, Ostor A. Early treatment of psoriatic arthritis improves prognosis. Practitioner 2014 Dec;258(1777):21–24, 3.
  3. Johns Hopkins Arthritis Center. Arthritis information: Psoriatic arthritis. 2020.
  4. National Psoriasis Foundation. Statistics. 2020.
  5. National Psoriasis Foundation. About psoriatic arthritis. 2020.

Notes

A. ACR20 Response: defined as both improvement of 20 percent in the number of tender and number of swollen joints, and a 20 percent improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure, visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).

B. Health Assessment Questionnaire Disease Index (HAQ-DI): includes 8 categories, reviewing a total of 20 specific functions to evaluate patient difficulty with activities of daily living over the past week. Categories include dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and errands and chores.

C. SF-36 Physical Component Summary: 8 multi-item scales assessing physical function, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and emotional well-being.

D. Functional Assessment of Chronic Illness Therapy—Fatigue (FACIT-F) Scale: measured on a 4-point Likert scale (4=not at all fatigued to 0=very much fatigued).

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

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