Risankizumab as a Long-Term Treatment
Risankizumab, sold under the brand name Skyrizi®, is a biologic medication that targets and inhibits interleukin-23 (IL-23), a cytokine involved in the inflammation associated with several autoimmune diseases. Because conditions such as plaque psoriasis, psoriatic arthritis (PsA), and Crohn's disease (CD) are chronic, they often require long-term management to control symptoms and maintain a good quality of life. The duration of risankizumab treatment is not defined by a maximum time limit but rather by the patient's sustained response and tolerance to the therapy, in consultation with their healthcare provider.
Duration of Treatment and Disease-Specific Outcomes
Long-term data from clinical trials and real-world studies provide strong evidence for the durability of risankizumab's effects across different conditions. Key findings include:
- Plaque Psoriasis: Final results from the LIMMitless trial show that continuous risankizumab treatment remained highly effective and well-tolerated through 6 years of therapy. At the 6-year mark, a large percentage of patients maintained significant skin clearance and improved quality of life.
- Psoriatic Arthritis: Integrated safety analyses covering up to 4 years of risankizumab exposure confirm a favorable safety profile and sustained efficacy for managing both skin and joint symptoms in patients with PsA.
- Crohn's Disease: Real-world studies have demonstrated that risankizumab can be effective for long-term use in patients with CD, even for those with extensive prior biologic exposure. Data shows maintenance of clinical remission and endoscopic healing over more than a year.
Understanding Long-Term Efficacy and Safety
Several large-scale, long-term extension studies have provided extensive data on the safety and efficacy of risankizumab. The findings confirm its suitability for chronic conditions that require ongoing treatment for symptom control.
Consistent Safety Profile
Long-term safety data from thousands of patient-years of exposure has been analyzed across both psoriasis and psoriatic arthritis populations. The results show:
- The rate of adverse events (AEs) over time has remained low and consistent with initial short-term trials.
- Serious infections, malignancies, and major adverse cardiovascular events (MACE) were reported at rates that were within or lower than established benchmarks from other large registry studies.
- Specifically for psoriasis, a study through 6 years showed that cumulative rates of treatment-emergent adverse events (TEAEs) and serious AEs remained low or decreased over time.
Durable Efficacy
The efficacy of risankizumab is not only high but also durable over long periods of continuous treatment. For example, in psoriasis patients who continued on risankizumab after an initial response, a high degree of skin clearance was maintained or even improved over several years. A similar durability of response has been noted in studies for psoriatic arthritis and Crohn's disease.
The Impact of Treatment Interruption
Treatment with risankizumab is meant to be continuous for as long as it remains effective and safe. Discontinuing the medication, even after achieving a clear response, typically leads to a relapse of symptoms. Studies have highlighted this pattern:
- Patients who withdrew from risankizumab experienced a deterioration in their health-related quality of life (HRQL) and an increase in disease symptoms.
- This deterioration in HRQL often happens more rapidly than the decline in objective measures of disease severity, suggesting a significant psychosocial impact of stopping treatment.
- For those who relapse, re-treatment with risankizumab can successfully regain the previously achieved response rates, showing that re-treatment is a viable option if necessary.
Monitoring and Shared Decision-Making
Since risankizumab is a long-term therapy, regular monitoring by a healthcare provider is essential. This includes assessing the treatment's effectiveness and monitoring for any adverse effects. The decision on how long to continue treatment is a shared one between the patient and their doctor, based on ongoing evaluations of benefit and risk.
Risankizumab vs. Other Biologics: Long-Term Outlook
| Feature | Risankizumab | Other IL-23 Inhibitors (e.g., Guselkumab, Tildrakizumab) | Other Biologics (e.g., TNF Inhibitors) |
|---|---|---|---|
| Mechanism of Action | Selective IL-23 p19 inhibitor | Selective IL-23 p19 inhibitor or IL-12/23 p40 inhibitor | Diverse; TNF-alpha blockade, IL-17 inhibition, etc. |
| Psoriasis Long-Term Efficacy | High and durable skin clearance through at least 6 years of continuous therapy. | High and durable efficacy reported through 4-5 years in various studies. | Varying long-term efficacy; some patients may lose response over time. |
| Psoriasis Long-Term Safety | Favorable safety profile consistent through 6 years, with low rates of AEs and serious AEs. | Generally consistent safety profiles with risankizumab, based on available long-term data. | Safety profiles vary; some may have higher risk of specific AEs like infusion reactions or latent TB reactivation. |
| Crohn's Disease Long-Term | Effective in maintaining remission and endoscopic healing for at least a year. | Long-term data varies by agent, but overall, sustained efficacy is a goal. | Variable efficacy; often used as initial therapy, but subsequent options are needed for those who fail. |
| Treatment Discontinuation | Symptoms and quality of life deteriorate, but re-treatment is effective. | Response rates decrease upon withdrawal, with re-treatment generally being effective. | Response rates can drop upon discontinuation, with some agents carrying risks upon re-initiation. |
Conclusion
Long-term clinical data, including up to 6 years for plaque psoriasis, supports that risankizumab can be taken for an extended, continuous period to manage chronic inflammatory conditions. Its durable efficacy and consistent safety profile, with adverse event rates remaining low or decreasing over time, make it a suitable option for long-term therapy. The decision regarding treatment duration is a medical one made in consultation with a doctor, considering the patient's individual response, disease activity, and overall health status. For optimal disease control and maintenance of quality of life, continuous therapy is generally recommended.
For more detailed information on Skyrizi, including prescribing and safety information, you can visit the official manufacturer's website. https://www.skyrizi.com/
