A recent double-center retrospective cohort study has provided valuable real-world evidence comparing the effectiveness and safety of two selective interleukin-23 (IL-23) inhibitors, risankizumab and guselkumab, in patients with moderate-to-severe psoriasis over a 52-week treatment period.
The study enrolled 90 patients, with 49 (54.4%) receiving guselkumab and 41 (45.6%) receiving risankizumab following standard dosing regimens. Guselkumab was administered as 100 mg doses at weeks 0, 4, and then every 8 weeks, while risankizumab was given as 150 mg doses at weeks 0, 4, and then every 12 weeks.
Comparable Efficacy Profiles
Both treatments demonstrated robust efficacy throughout the study period. At week 16, PASI90 (90% improvement in Psoriasis Area and Severity Index) responses were significantly higher in the guselkumab group (95.9%) compared to the risankizumab group (80.5%, p=0.039). However, PASI100 (complete clearance) rates were similar between guselkumab (34.7%) and risankizumab (34.1%) at this timepoint.
By week 52, both treatments showed comparable and impressive efficacy with PASI90 responses of 93.9% for guselkumab and 93.0% for risankizumab. PASI100 responses at week 52 were 57.1% and 53.7% for guselkumab and risankizumab, respectively, with no statistically significant differences between the groups.
"These results demonstrate that both guselkumab and risankizumab maintain high levels of efficacy through one year of treatment in real-world clinical practice," noted the study authors. "The response rates observed are consistent with or even exceed those reported in pivotal clinical trials."
Effectiveness Across Patient Subgroups
A key finding was that treatment outcomes remained consistent regardless of patient characteristics. The study found no significant differences in PASI100 responses at weeks 4, 16, 24, and 52 between:
- Bionaive versus bioexperienced patients
- Obese versus non-obese patients
- Patients with versus without comorbidities
- Patients with versus without psoriatic arthritis
This suggests both treatments are effective across diverse patient populations, including those who have previously failed other biologics such as anti-TNF, anti-IL17, and/or anti-IL12/23 therapies.
Safety and Tolerability
Both treatments demonstrated favorable safety profiles. Adverse events were reported in 20.4% of guselkumab-treated patients and 24.4% of risankizumab-treated patients, with no statistically significant difference between groups. The most common adverse events included pharyngitis, flu-like illness, and headache.
Treatment discontinuation rates were low and similar between groups. In the guselkumab arm, two patients (4.1%) discontinued due to secondary unresponsiveness. In the risankizumab arm, two patients (4.9%) discontinued due to secondary unresponsiveness, and one patient (2.4%) discontinued due to exacerbation of joint complaints.
No serious adverse events requiring hospitalization were reported, and no cases of tuberculosis activation were observed during the study period.
Special Populations and Treatment Areas
The study also evaluated treatment efficacy in patients with specific psoriasis manifestations. Interestingly, guselkumab showed significantly higher PASI100 responses at week 4 among patients with scalp involvement (p=0.006), though this difference was not maintained at later timepoints.
No significant differences were observed between treatments in patients with genital area involvement at any timepoint. Both treatments were effective for these difficult-to-treat areas, which often significantly impact patients' quality of life.
Comparison with Previous Studies
These findings align with other real-world studies of IL-23 inhibitors. A study by Ruggiero et al. previously found similar efficacy between guselkumab and risankizumab through 44 weeks of treatment. The current study extends these observations to 52 weeks and provides additional data on treatment responses in specific patient subgroups.
The efficacy rates observed in this real-world study were generally comparable to or higher than those reported in pivotal clinical trials. For guselkumab, the VOYAGE-1 and VOYAGE-2 trials reported PASI90 rates of approximately 70% at week 16, compared to 95.9% in the current study. For risankizumab, the UltIMMa-1 and UltIMMa-2 trials reported PASI90 rates of approximately 75% at week 16, compared to 80.5% in this real-world cohort.
Clinical Implications
"These findings have important implications for clinical practice," commented one of the study investigators. "The comparable efficacy and safety profiles of both IL-23 inhibitors, along with their effectiveness across diverse patient populations, provide clinicians with valuable options for long-term psoriasis management."
The study results suggest that both guselkumab and risankizumab are effective and well-tolerated treatment options for moderate-to-severe psoriasis in real-world clinical practice. The high response rates observed at week 52 indicate that both treatments provide durable efficacy over at least one year of treatment.
Study Limitations
The authors acknowledged several limitations, including the relatively small sample size, retrospective design, and limited follow-up period, which may affect the generalizability of the results. Additionally, the study did not include a control group, which limits direct comparisons with other treatment options.
Despite these limitations, this real-world study provides valuable insights into the comparative effectiveness and safety of guselkumab and risankizumab in routine clinical practice, complementing the evidence from randomized controlled trials.
Future Directions
Longer-term studies with larger patient populations are needed to further evaluate the durability of response and long-term safety of these IL-23 inhibitors. Additionally, head-to-head randomized controlled trials would provide more definitive evidence regarding the comparative efficacy of these treatments.
As more real-world data accumulate, clinicians will gain a better understanding of how to optimize treatment selection for individual patients with moderate-to-severe psoriasis, potentially leading to more personalized treatment approaches.
