The FDA has approved golimumab for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
The FDA has approved golimumab (Simponi Aria, Janssen Pharmaceutical Companies) for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (JIA). Additionally, the FDA has extended the use of golimumab to treat psoriatic arthritis (PsA) in this same patient population.
Golimumab is a fully human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody designed to target soluble and transmembrane bioactive forms of human TNF-alpha. When overproduced in the body, TNF-alpha is a protein that can cause chronic inflammation.
"This latest FDA approval of Simponi Aria for pediatric use in active pJIA and active PsA not only brings a new option to young patients living with these diseases but also adds to the growing body of evidence for this treatment," said Mathai Mammen, MD, PhD, global head of Janssen Research and Development at Johnson & Johnson, in a press release. "For more than 20 years, we at Janssen have been committed to researching anti-TNF biologic agents for immune-mediated diseases and are encouraged to expand treatment options for these patients."
Characterized by symptoms of arthritis that persist for 6 weeks or more before the age of 16 years, JIA is a group of disorders that affects 300,000 children in the United States. The form of JIA that is most common is polyarticular, which is characterized by inflammation in more than 4 joints, resembling adult rheumatoid arthritis (RA).
Among pediatric patients, PsA is one of the rarest subtypes of JIA. PsA results in symptoms that are similar in both children and adults, which include joint inflammation and skin lesions that are commonly associated with psoriasis.
"For far too long, children with pJIA or PsA have had limited treatment options," said Seth D. Ginsberg, co-founder and president of the Global Healthy Living Foundation and CreakyJoints, in a press release. "This approval represents an important step forward for these children and their families."
The approval for golimumab was based on results from the GO-VIVA phase 3 clinical trial. The open-label study included children aged 2 to 17 years with JIA with active polyarthritis who had active arthritis in 5 or more joints. All patients included in the trial had also received a treatment with methotrexate for at least 2 months prior to treatment with golimumab.
The researchers found that the pharmacokinetic exposure of golimumab in the GO-VIVA clinical trial was consistent with the results of 2 other phase 3 clinical trials assessing golimumab in adult patients with moderately to severely active RA and active PsA.
The results also demonstrated that the efficacy of golimumab was consistent with the responses of adult patients with RA. Additionally, the adverse effects were consistent with the previously established safety profile of golimumab in adult patients with RA and PsA.
"Due to the limited availability of pediatric patients for inclusion in clinical trials, it can be challenging to build clinical studies for this young patient population," said Daniel J. Lovell, the Joseph E. Levinson professor of pediatric rheumatology at Cincinnati Children's Hospital MedicalCenter, in a press release. "Given these challenges, I am pleased to see Janssen advance the approval of a new treatment option for pediatric patients with pJIA and PsA—an important milestone in the treatment of these complex, heterogeneous diseases."
SIMPONI ARIA® (golimumab) Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older. Horsham, PA: Janssen Pharmaceutical Companies; September 30, 2020. prnewswire.com/news-releases/simponi-aria-golimumab-approved-by-the-us-food-and-drug-administration-for-active-polyarticular-juvenile-idiopathic-arthritis-and-extension-of-its-active-psoriatic-arthritis-indication-in-patients-2-years-of-age-and-older-301141976.html?tc=eml_cleartime. Accessed October 1, 2020.