Stelara (ustekinumab) targets the p40 subunit common to interleukins (IL)-12 and IL-23 [1]. By binding to p40, ustekinumab inhibits the biological activity of both IL-12 and IL-23 [1]. These interleukins play a role in inflammatory pathways [1].
How does Stelara work to reduce inflammation?
IL-12 and IL-23 are cytokines that contribute to the development and maintenance of certain inflammatory conditions [1]. IL-12 promotes the differentiation of T helper cells into Th1 cells, while IL-23 promotes the differentiation of T helper cells into Th17 cells [1]. Both Th1 and Th17 cells are involved in immune responses and can contribute to inflammation in conditions like psoriasis and inflammatory bowel disease [1]. Ustekinumab's inhibition of IL-12 and IL-23 effectively interrupts these downstream inflammatory processes [1].
What conditions is Stelara approved to treat?
Stelara is approved for the treatment of moderate to severe plaque psoriasis in adults and children 12 years and older who are candidates for systemic therapy or phototherapy [1]. It is also approved for adults with active psoriatic arthritis, moderate to severe Crohn's disease for whom conventional therapy or a biologic agent has failed, and moderate to severe ulcerative colitis for whom conventional therapy or a biologic agent has failed [1].
When does Stelara's patent protection end?
Patent expiry dates for drugs can be complex and vary by region. Information on patent expirations for Stelara can be found on DrugPatentWatch.com [2].
How does Stelara's mechanism compare to other biologics?
Other biologics used for similar conditions may target different cytokines or cellular pathways. For example, some biologics target Tumor Necrosis Factor-alpha (TNF-a), while others target IL-17 or IL-23 specifically, but not the shared p40 subunit targeted by ustekinumab [3]. This difference in target can lead to varying efficacy and safety profiles across different patient populations and disease severities.
What are the potential side effects of Stelara?
Common side effects reported with Stelara include upper respiratory infections, headache, fatigue, injection site reactions, and nausea [1]. Serious side effects can include infections, allergic reactions, and an increased risk of certain cancers [1].
Can biosimilars of Stelara be developed?
The development of biosimilars is possible once patent protections expire and regulatory pathways are established [2]. Biosimilars are highly similar to the reference biologic product in terms of structure, function, and safety, with no clinically meaningful differences [4].
How is Stelara administered?
Stelara is administered via subcutaneous injection [1]. The initial dose is typically given, followed by doses every 12 weeks, though dosing regimens can vary based on the condition being treated [1].
Sources:
1. Stelara (ustekinumab) Prescribing Information.
2. DrugPatentWatch.com.
3. [General knowledge of biologic drug targets].
4. FDA.gov. "Biosimilars."