Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
Risankizumab has demonstrated clear clinical advantages over placebo in three randomized controlled trials, with statistically significant improvements in primary and secondary endpoints, including ACR and PASI response rates. However, it has not been directly compared to other biological DMARDs, which limits the strength of the evidence.
Cost effectiveness
The cost comparison analysis indicates that risankizumab is likely to be cost-effective, with total costs similar to or lower than those of guselkumab, which is a key comparator. The analysis aligns with NICE’s cost-effectiveness thresholds.
Quality of life
The evidence suggests moderate improvements in HRQoL metrics, particularly through the PASI scores, indicating positive impacts on skin symptoms. However, specific HRQoL data from validated instruments were not detailed in the document.
Supporting Domains
Safety and Adverse Effects
Risankizumab has shown a very good safety profile, with no significant differences in adverse events compared to guselkumab. The evidence suggests that adverse events are mostly mild to moderate, supporting its tolerability.
Comparator Selection
The document indicates that risankizumab was compared to guselkumab, which is appropriate given the similar mechanisms of action and the context of treatment for active psoriatic arthritis. However, the lack of direct comparisons with other biological DMARDs is a limitation.
Patient Population and Subgroups
The trials included a diverse population of adults with active psoriatic arthritis, and the results are considered generalizable to the intended patient population. However, there are some limitations regarding the subgroup with prior biological DMARD use.
Care Pathway Integration
Risankizumab can be integrated into existing treatment pathways with minor adjustments, as it aligns with current clinical practices for assessing treatment response at 16 weeks.
Resource Use and Cost Implications
The budget impact analysis indicates that the resource implications of adopting risankizumab are manageable, with costs being similar to those of existing treatments. This suggests a justifiable cost burden relative to the benefits.
Evidence Quality and Robustness
The evidence is based on multiple randomized controlled trials with a total of 1,592 participants, providing a robust foundation. However, some methodological concerns and the reliance on indirect comparisons introduce some uncertainty.
Uncertainty, Sensitivity, and Broader Impacts
While there are some uncertainties regarding the indirect comparisons and subgroup analyses, the overall context of unmet need and the alignment with clinical practice help mitigate these concerns.
