Risankizumab for the Treatment of Moderate-to-Severe Psoriasis: Real-Life Multicenter Experience from the Czech Republic

Gkalpakiotis, Spyridon; Cetkovská, Petra; Arenberger, Petr; Doležal, Tomáš; Velacková, Barbora; Fialová, Jorga; Kojanová, Martina

doi:10.1007/s13555-021-00556-2

Cited by 36 publications

(74 citation statements)

References 20 publications

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“…To date, there is no study dedicated to risankizumab in PsA patients. Although in phase III and real‐life studies the affected population also at the joint level is between 20–30%, no specific efficacy analysis has been performed on this subpopulation 2–4 . In our study, 22% of patients had joint involvement, which is in line with the current literature, and showed a generally poorer response to treatment.…”

Section: Discussionsupporting

confidence: 89%

“…The reduction of the mean PASI in our population was consistent as early as 16 weeks and showed a tendency for further reduction at subsequent endpoints. The mean PASI score decreased from 12.5 (SD 5.1) at baseline to 1.9 (SD 2.4) at week 16 which is similar to the mean PASI score reported in the Czech study by Gkalpakiotis et al on 94 patients and an Italian study by Megna et al on 8 patients, 1.7 (SD 2.3) and 3.3 (SD 1.7), respectively 2,10 . We observed a similar reduction in the achievement of PASI 100, PASI 90, PASI 75, and PASI <3.…”

Section: Discussionsupporting

confidence: 89%

“…Although the smoking habit is considered a negative factor in the course of psoriasis and its response to biologics, as recently mentioned in the systematic review by Zhou et al, the response to risankizumab has never been evaluated concerning presence or absence of this habit, neither in phase III clinical trials nor in real‐life studies 2,3,12 . In our study we found limited differences attributed to smoking habits.…”

Section: Discussionmentioning

confidence: 44%

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Risankizumab shows high efficacy and maintenance in improvement of response until week 52

Mastorino

Susca

Megna

et al. 2022

Dermatologic Therapy

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Risankizumab has been recently approved for moderate‐to‐severe plaque psoriasis; however, real‐life studies are scarce. Analysis of possible predictor factors of treatment response are limited to body mass index (BMI) and previous biologic experience. Our objectives were to evaluate the effectiveness and safety of Risankizumab and to investigate on possible predictor factors response. We retrospectively analyzed 166 patients from two centers in Italy who undergone Risankizumab for psoriasis. The proportion of patients achieving a 100%, 90%, 75% of improvement in Psoriasis Area Severity Index (PASI) and PASI <3 were collected at weeks 16, 28, 40, and 52. Study population was analyzed in subgroups to investigate possible predictors of response to Risankizumab since week 40. At the time of analysis 165, 103, 30, and 11 patients had completed 16, 28, 40, and 52 weeks of treatment, respectively. The mean PASI score decreased from 12.5 ± 5.1 at baseline to 1.9 ± 2.4 at week 16. Similar reductions were observed when considering PASI <3, PASI 75, PASI 90, and PASI 100. Previous biologics failure, different smoking habits, obesity, and joint involvement resulted in a lower response to risankizumab. In particular, significant differences in mean PASI at any time‐points was observed between psoriatic arthritis (PSA) and non‐PSA patients: 2.7 versus 1.7 (p = 0.036), 1.9 versus 0.4 (p = 0.006), and 4.1 versus 0.5 (p = 0.016) at 16, 28, and 40 weeks, respectively. No difference in response to risankizumab occurred in the case of involvement of difficult‐to‐treat areas. In this population, Risankizumab was effective and safe. Smoking habits, joint involvement, obese status, and previous biologic experience may negatively affect treatment response, while difficult body sites involvement have minor impact.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 44%

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Risankizumab shows high efficacy and maintenance in improvement of response until week 52

Mastorino

Susca

Megna

et al. 2022

Dermatologic Therapy

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“…Robust and durable responses with risankizumab have also been demonstrated outside the clinical trial setting. A retrospective analysis of 154 patients with moderate-to-severe plaque psoriasis from multiple centers in the Czech Republic who were treated with risankizumab and followed up to 1 year found that PASI90 and PASI100 were achieved by 63.8% and 44.7% of patients, respectively, at week 16 and 82.4% and 67.6% of patients, respectively, at week 52 [ 19 ]. This trend was accompanied by an improvement in life quality, as reflected by a decline in DLQI over time.…”

Section: Discussionmentioning

confidence: 99%

Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials

Lebwohl

Soliman

Yang

et al. 2021

Dermatol Ther (Heidelb)

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Introduction: Novel therapies have allowed psoriasis patients to achieve high levels of skin clearance and meaningful improvements in health-related quality of life measures; however, duration of these outcomes has not been evaluated. This study aimed to estimate the duration of Psoriasis Area and Severity Index (PASI) 90 and Dermatology Life Quality Index (DLQI) 0/1 among patients with moderate-to-severe psoriasis receiving risankizumab and other treatments. Methods: Pooled data from four phase 3 randomized clinical trials of risankizumab were used to estimate the number and proportion of days with PASI90 and DLQI0/1 during the 1-year post-baseline period with an area-underthe-curve approach. Patients were classified into five cohorts on the basis of their treatment experience during the follow-up period: risankizumab (RISA) only, RISA followed by re-randomization to RISA or placebo (RISA and RISA/ PBO), adalimumab (ADA) followed by re-randomization to ADA or RISA (ADA and ADA/ RISA), ustekinumab (UST) only, and placebo followed by risankizumab (PBO/RISA). Results: A total of 2101 patients were included in this analysis. Mean age was 47.5 years, 70% were males, and mean duration since psoriasis diagnosis was 18.6 years. Patients treated with RISA only throughout the study period experienced the longest PASI90 [245.7 days (67% over 1 year)] and DLQI0/1 [213.7 (59%)] duration. Patients treated with PBO/RISA [156.8 (43%)] and UST only [154.2 (42%)] experienced the shortest PASI90 duration. Similarly, patients treated with PBO/RISA experienced the shortest DLQI0/1 duration during the 52-week study period [90.5 (25%)]. Conclusion: Patients with moderate-to-severe psoriasis treated with risankizumab exhibited longer durations of PASI90 and DLQI0/1 than patients treated with other therapies.

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“…Moreover, the levels of IL-17A, IL-22, and IL-23 were significantly enhanced in patients with active disease compared with those with stable diseases (39). Olejniczak-Staruch et al and Gkalpakiotis et al documented that long-term biologic therapy with anti-TNFα drugs improved the PASI score, reduced systemic and local inflammation, and decreased the markers of inflammation such as CRP, IL-2, IL-22, etc (40,41). Correlation between IL-22 and severity of disease and between IL-22 and IL-17 was proven in studies by Sobhan et al and Elala et al Sobhan discovered that the level of IL-22 was significantly higher in patients with psoriasis compared to healthy controls and correlated with PASI (42,43).…”

Section: Discussionmentioning

confidence: 99%

Goeckerman Regimen Reduces Alarmin Levels and PASI Score in Paediatric Patients with Psoriasis

Holmannová

Císařová

Borský

et al. 2021

Acta Med. (Hradec Kralove, Czech Repub.)

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Background. Psoriasis is a chronic systemic inflammatory disease with (extra-)cutaneous manifestations. Inflammation is associated with cellular stress and tissue damage which lead to the release of alarmins (signals of danger). Goeckerman regimen (GR) is a highly efficacious treatment consisting of the application of pharmaceutical crude tar and UVB light exposure. The reduction of inflammatory processes in the skin is accompanied by changes in the levels of inflammatory markers - alarmins (HMBG-1, S100A7, S1000A8, S100A9, S100A12, IL-17, IL-22, and IL-33). Methods. The alarmin levels in sera of 19 paediatric patients with psoriasis were determined before and after GR using commercial ELISA kits. The Psoriasis area severity index (PASI) was used to determine the disease severity. Results. GR reduced both PASI and the levels of all measured alarmins. The levels of S100A7, S100A9, IL-22, IL-33, and HMGB-1 were significantly decreased. Positive correlations between IL-22 and PASI, between S100A9 and IL-17, S100A9 and IL-22, and a negative correlation between S100A8 and IL-33 were found. Conclusions. Goeckerman regimen is a very effective, safe and low-cost therapy. We confirmed, it modulates the immune system reactivity, ameliorates the severity of the disease and reduces the levels of alarmins reflecting the presence and intensity of inflammation.

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Risankizumab for the Treatment of Moderate-to-Severe Psoriasis: Real-Life Multicenter Experience from the Czech Republic

Cited by 36 publications

References 20 publications

Risankizumab shows high efficacy and maintenance in improvement of response until week 52

Risankizumab shows high efficacy and maintenance in improvement of response until week 52

Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials

Goeckerman Regimen Reduces Alarmin Levels and PASI Score in Paediatric Patients with Psoriasis

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