Psoriatic Arthritis

If approved, the new indications include children 6 years and older with moderate to severe plaque psoriasis and children 5 years and older with active juvenile psoriatic arthritis.

The biosimilar is approved for the treatment of Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

The FDA previously accepted the biologic license application for CT-P13 as a subcutaneous formulation.

Approved with 3 new indications, bimekizumab-bkzx is the first and only interleukin-17 inhibitor approved for these diseases.

Ustekinumab-ttwe (Pyzchiva; Sandoz) is approved for all of the same indications as Stelara.

Investigators compared the reference products of adalimumab (Humira; AbbVie) and etanercept (Enbrel; Amgen) with biosimilar products.

Ustekinumab (Stelara; Janssen Immunology) is a human monoclonal antibody that treats immune-mediated diseases such as psoriasis and psoriatic arthritis.

The 3 bimekizumab indications include psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.

In 2024, there is an urgent need for policies that will accelerate biosimilar use to achieve lower system-wide health care costs.

Adalimumab-aqvh (Yusimry; Coherus Biosciences) entered the market in July 2023, following approval by the FDA in December 2021.

The sBLA was based on data from a clinical study assessing the pharmacokinetics of switching between adalimumab and adalimumab-bwwd for patients with moderate to severe plaque psoriasis.

TAK-279 is an investigational oral allosteric tyrosine kinase 2 inhibitor for active psoriatic arthritis.

The biosimilar, now legally available at the pharmacy level, demonstrated similar safety, purity, and potency to the reference product.

The approval is supported by safety data from clinical trials assessing abatacept in the treatment of patients aged 2 to 17 with psoriatic arthritis.

New products and medications can be used as single agents or in combination with other agents for optimal treatment outcomes.

The intravenous formulation of secukinumab is administered in monthly 30-minute, weight-based dosing and requires no pre-medication or lab monitoring.

Previously, upadacitinib improved symptoms through 2 years in the SELECT-PsA 1 trial for those with psoriatic arthritis with prior inadequate response or intolerance to ≥1 non-biologic disease-modifying antirheumatic drug.

It is the second anti-TNFα biosimilar approved for use in the US.

Adalimumab-adbm (Cyltezo Pen; Boehringer Ingelheim) is approved by the FDA as an interchangeable biosimilar to Humira.

Due to the disease’s chronicity, the variability in treatment response and drug safety profiles, and the availability of multiple therapies, switching or discontinuing treatments is common in psoriasis.

The results of the INSPIRE trial demonstrated that 20.3% of individuals receiving risankizumab (Skyrizi) achieved clinical remission compared to 6.2% of individuals who received the placebo.

Sandoz intends to launch the latest Humira biosimilar in the United States on July 1, 2023.

Results of 2 phase 3 clinical trials demonstrate better response rate beyond the primary endpoint analysis at week 16 to more than 55 at week 55.

All primary and ranked secondary endpoints of the study were met at week 16, which were sustained or improved through week 24 and were coupled with patient-reported improvements compared with placebo in treating psoriatic arthritis.

Adalimumab-aacf (Idacio) is indicated for chronic conditions such as rheumatoid arthritis, plaque psoriasis, ulcerative colitis, psoriatic arthritis, hidradenitis suppurativa, and juvenile idiopathic arthritis.

A modified secukinumab dosing regimen produced outcomes on par with currently recommended intervals in patients with moderate-to-severe psoriasis, but longer follow-ups are needed to confirm the findings.

Guselkumab (Tremfya) is a fully human selective IL-23 inhibitor therapy FDA-approved for the treatment of adults with active psoriatic arthritis and with moderate to severe plaque psoriasis.

Research shows that patients with a severe form of psoriasis have a higher risk of death from cardiovascular disease.

The ability of an anti-interleukin-23 antibody to bind to key immune system components may help neutralize a key driver of inflammation right at its cellular source.

Ustekinumab is the first and only biologic that targets both cytokines interleukin (IL)-12 and IL-23.