Ustekinumab under the trade name Stelara (also known as CNTO 1275) is an immunosuppressant used to treat plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Ustekinumab as the first biologic therapy for Crohn’s disease, is the only treatment for Crohn’s disease that starts with a weight-based, one-time intravenous (IV) infusion induction dose. Injection site reaction is the common Stelara side effect. Stelara cost is around $21,792.96, but the pharmaceutical price for hospitals is around $19,611.10 (12% off the average retail price).
Approvment of Stelara
In 2007: there were 5 NIH-listed research studies involving CNTO 1275 on a multinational basis, focused on patients with psoriasis, psoriatic arthritis, and on multiple sclerosis.
From September 2017: it is available on the Pharmaceutical Benefits Scheme for the treatment of severe Crohn’s disease in adults.
In 2008: the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended Ustekinumab for the treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to other systemic therapies.
In 2009: the FDA approved Ustekinumab for the treatment of Psoriasis.
In 2013: the FDA approved Ustekinumab for the treatment of Active Psoriatic Arthritis
In 2016: it was approved by the FDA for Treatment of Moderately to Severely Active Crohn’s Disease.
In 2017: the FDA approved Ustekinumab for the treatment of Moderate to Severe Plaque Psoriasis.
Indication of Stelara
Ustekinumab is indicated for the treatment of
- active psoriatic arthritis
- moderate to severe plaque psoriasis
- moderately to severely active Crohn’s disease who have:
- failed or were intolerant to treatment with immunomodulatory or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker, or
- failed or were intolerant to treatment with one or more TNF blockers.
Stelara side effect
- injection site reactions (bruising, itching, pain, redness, swelling, and hardening of the skin),
- cold symptoms (stuffy nose, sneezing, sore throat),
- tired feeling,
- diarrhea, or.
- skin rash or itching.
Mechanism of action
Ustekinumab is a human IgG1κ monoclonal antibody that can affect your immune system and can lower your body’s ability to fight an infection. It binds to and inhibits the biological activity of naturally occurring cytokines (IL)-12 and IL-23, which are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation.
Stelara in the Market
It is expected that sales in major markets of drugs to treat psoriasis, witness robust growth over the next decade, increasing from $6.6 billion in 2013 to $10.7 billion in 2023.
Increasing awareness about treatment and rising demand for improved healthcare infrastructure are major factors driving the psoriasis market. The changing lifestyle of people leading to increased alcohol consumption and smoking, an unhealthy diet and sedentary living are the factors that make more people prone to this condition. This condition may not be present at birth; it may be triggered by certain environmental and genetic factors.
The market of psoriasis drugs can be divided into various therapeutic classes such as Tumor Necrosis Factor (TNF)-inhibitors, Interleukin inhibitors, and Vitamin D Analogues while TNF inhibitors have dominated the therapeutic space. The marketed TNF-inhibitors used for psoriasis include Humira (adalimumab), Enbrel (etanercept) and Remicade (infliximab).
It is expected that Interleukin (IL) inhibitors witness the fastest growth due to their improved safety and efficacy profiles and rising adoption among end users. Marketed interleukin inhibitors are Stelara (ustekinumab), Cosentyx (Secukinumab), Taltz (Ixekizumab), Siliq (Brodalumab) and Tremfya (Guselkumab).
Some of the key companies operating in this industry and pharmaceutical seller for the hospitals are AbbVie Inc., Amgen Inc., Johnson & Johnson, Novartis AG, Eli Lilly & Company, AstraZeneca and Celgene Corporation while Several companies such as Boehringer Ingelheim and Sun Pharma have promising drugs in the pipeline.
The dominant region in this market is the U.S. with more than 35.0% market share in 2016. Few factors responsible for its large share include established healthcare infrastructure, high adoption of therapeutics and presence of key manufacturers in the U.S. Some of the drivers fueling the market growth are increasing prevalence and favorable government initiatives.
Due to the rising awareness about early diagnosis, high unmet clinical needs of patients, rising disposable income and availability of effective treatment in Japan, it is estimated that pharmaceutical supply chain for hospitals witnesses the fastest growth next years with CAGR of around 13.0% in this country.
According to a report from Decision Resources, continued uptake of Stelara will drive sales growth in the US, France, Germany, Italy, Spain, the UK, and Japan. It is expected that Stelara achieves sales in these markets of some $2.4 billion in 2023, representing nearly 22% of total sales of psoriasis drug treatments.
Launches and uptake of several emerging IL-17 inhibitors – Novartis’ Secukinumab, Eli Lilly’s Ixekizumab and Amgen/AstraZeneca/Kyowa Hakko Kirin’s Brodalumab – plus Pfizer’s Jak inhibitor Beljan (Tofacitinib) will drive the sales.