There are different treatment options for psoriasis. As a biologic, ustekinumab is used for treating moderate-to-severe psoriasis [6, 7].
The Active Comparator (CNTO1275/Enbrel) Psoriasis Trial (ACCEPT) showed ustekinumab had a rapid onset of action [6]. We obtained similar results in our study. Our findings also revealed male patients improved faster than female patients. The treatment response rate was also higher in male cases than females. Of note, male patients were more compliant with the follow-up encounters, and they were more enthusiastic about the ustekinumab treatment than female patients. We also observed that in cases with favorable response to one dose or two doses of ustekinumab, this positive effect of this medication tended to persist. On the other hand, in patients with an unfavorable response to one or two doses of this medication, the possibility of reaching PASI 75 response was decreased.
During ustekinumab treatments, any adverse events occured in many researchs [6, 8, 9]. In our study, our patients did not experience any severe adverse effects during ustekinumab treatment. Therefore, we believe our study made a significant contribution to the literature in this regard.
The PASI 75 response is essential for assessing the efficacy of a biologic used in treating psoriasis. The studies NCT02684370 (UltIMMa-1) and NCT02684357 (UltIMMa-2) determined PASI 75 response to ustekinumab was 70% and 69,7% at the 12th week. In UltIMMa-1, PASI 90 response was 42% at week 16 and 44% at week 52, while PASI 100 response was 12% at week 16 and 21% at week 52. In UltIMMa-2, PASI 90 response was 47,5% at week 16 and 50% at week 52. This study also reported the PASI 100 response was 24% at week 16 and 30,3% at the 52nd week [10]. In our study, the mean duration for reaching PASI 75, PASI 90, and PASI 100 response was less than 10 weeks. These findings showed our patients responded rapidly and efficiently to ustekinumab treatment.
In the PHOENIX 1 study, the authors compared the outcomes of ustekinumab 45 mg treatment (n = 255), ustekinumab 90 mg treatment (n = 256) and placebo (n = 255) [5]. They reported the maximum efficacy was obtained at week 24 in both ustekinumab 45 mg and 90 mg groups. They also noted PASI 75 response was reached by 191 of 251 (76.1%) patients in the 45 mg group and by 209 of 246 (85%) patients in the 90 mg group and approximately half of the patients in both 45 mg and 90 mg ustekinumab groups achieved at least a 90% improvement (i.e., PASI 90) at week 28. Approximately one-third of the cases in both ustekinumab groups reached PASI 100 response at week 12. On the other hand, half of the patients in the ustekinumab 45 mg group and 71% in the ustekinumab 90 mg group achieved PASI 100 response at week 28. In the PHOENIX 2 study, nearly half of the cases reached PASI 90 response at week 12, which was maintained at week 28 [11]. One-fifth of the patients reached PASI 100 response at week 12, which persisted in the ustekinumab 45 mg group at week 28. One-third of the ustekinumab 90 mg patients reached PASI 100 at the 28th week. The results of PHOENIX 1 and 2 indicate that treatment with ustekinumab 45 mg or 90 mg leads to a rapid and significant improvement in patients with moderate-to-severe psoriasis. Our findings are consistent with these studies.
Our analysis also revealed ustekinumab treatment was effective in both non-naïve and naïve cases. Overall, ustekinumab was effective in 80,55% of all non-naïve patients. This figure was 76,92% for non-naïve female patients and 82,6% for non-naïve male patients. These findings suggest ustekinumab is a reasonable treatment option for non-naïve patients. However, comparing the treatment responses revealed ustekinumab treatment was more effective in naïve patients than non-naïve patients. In the PHOENIX2 study, 38,4% of the patients in the 45 mg ustekinumab group (n = 409), 36,5% of the patients in the 90 mg ustekinumab group (n = 410) and 38,8% of the patients in the placebo group (n = 411) were previously treated with a biologic (i.e., etanercept, alefacept, efalizumab, infliximab and adalimumab) [12]. At week 28, only 12,1% of the PASI 75 responders were previously treated with at least one biologic.
In another study comparing etanercept and ustekinumab groups, patients in the former group who failed to respond to treatment after 12 weeks were switched to 90 mg of ustekinumab. After 12 weeks, 48,9% achieved PASI 75 and 23,4% achieved PASI 90 [13]. In the ACCEPT study, 50 etanercept group patients who did not have a physician global assessment (PGA) score of less than 3 at week 12 were switched to the ustekinumab group [14]. This study indicated that most patients responded favorably to ustekinumab after failing to respond to other biologics, but the response rates were relatively lower than primary treatments. Our findings are in line with this study.
Our findings suggest ustekinumab is a biologic with very few side effects, and it can be used safely in patients with various comorbidities. Furthermore, it is widely accepted that treating non-naïve cases is challenging; ustekinumab can be an appropriate treatment option for these patients. This positive effect persists in patients with favorable responses to the first or second dose of ustekinumab. However, in cases with an unfavorable response to the first or the second dose, the possibility of reaching PASI 75 response decreases significantly. In addition, male patients give more potent and more rapid responses to this treatment than female patients, and they are more enthusiastic about continuing their treatment than female cases.
Since long-term real-life clinical data regarding the treatment of psoriasis with ustekinumab are rare, we believe our findings will significantly contribute to the literature.
Main points:
1. Ustekinumab can be used safely in patients with various comorbidities.
2. Ustekinumab can be an appropriate treatment option for non-naïve patients.
3. Cases with an unfavorable response to the first or the second dose, the possibility of reaching PASI 75 response decreases significantly.
4. Male patients give more potent and more rapid responses to this treatment than female patients