Real-world clinical outcomes of treatment with brodalumab in patients with moderate-to-severe psoriasis: a retrospective, 24-month experience from four academic dermatology centers in Greece

Papadavid, Evangelia; Zafeiriou, Efterpi; Georgiou, Sophia; Roussaki-Schulze, Angeliki; Spiliopoulos, Theofanis; Vryzaki, Eleftheria; Oikonomou, Chrysa; Drongoula, Ourania; Boziou, Maria; Goudouras, Georgios; Sfaelos, Konstantinos; Apalla, Zoe; Lazaridou, Elisavet

doi:10.1080/09546634.2022.2110836

Cited by 5 publications

(17 citation statements)

References 20 publications

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“…Similar trends are reported in two other studies (85.7%-82.7%, 85.7%-73.1% and 71.4%-67.3% at Week 96, respectively). 11,13 Finally, the higher percentages were shown by Rompoti et al, 12 by reaching PASI90/100 response rates of 87.1% and 80.7%, respectively, at W104. Interestingly, our results are consistent with those derived from randomized controlled trials (RCTs); briefly, in AMAGINE-1, AMAGINE-2 and AMAGINE-3, PASI 90/100 ranged between 69%-70% and 37%-44% at W12, 22,23 respectively and 75.6% and 61.1% at Week 120, respectively.…”

Section: Discussionmentioning

confidence: 79%

“…On the other hand, another Greek, retrospective study extracted more conservative results, similar to ours, with the percentages of patients achieving PASI100 at Weeks 12, 24, 48 and 96 being 23.3%, 35.1%, 57.1% and 67.3%, respectively. 13 There is no clear explanation for these differences in PASI100 rates between the aforementioned studies. All had similar patient eligibility criteria and brodalumab doses with the only major differences being the prospective design of the current study versus the retrospective design of the other ones, as well as the difference in sample size.…”

Section: Discussionmentioning

confidence: 91%

“…A point that should be taken under consideration relates to the variations of the baseline PASI scores among study populations included in the different studies. For example, the three most recent Greek, retrospective studies included patients with baseline mean PASI scores of 12.7, 10.3 and 14.0, [11][12][13] whereas the respective score in our study was 17.3, representing a significant burden of disease. More prospective studies should be conducted in order to further address this between-studies difference in effectiveness.…”

Section: Discussionmentioning

confidence: 95%

“…Indicatively, in other studies, 87.3%-86.7%-81.4%, 81.8%-70.7%-72.9% and 72.7%-53.3%-57.1% of patients attained PASI75/90/100 at 48 weeks, respectively. 9,11,13 A recent retrospective Spanish study concluded that 75.9% and 68.7% of patients reached an absolute PASI ≤ 1 and 0 at week 52. 21 In our cohort PASI75/90/100 rates were achieved by 91.7%, 73.1% and 51.3% of patients at W52, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…8 Moreover, an increasing number of real-world studies investigating its effectiveness as well as patientreported outcomes (PROs) have been published. [9][10][11][12][13][14][15] In light of the above, we conducted this observational, prospective, multicentre study to (i) bridge the information gap between clinical trials and real-life practice with brodalumab and (ii) contribute to existing knowledge on brodalumab use. BrIDGE was the first prospective, real-world study assessing the effectiveness of brodalumab in a patient population with moderate-to-severe psoriasis in Greece.…”

Section: Introductionmentioning

confidence: 99%

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Real‐world data on the effectiveness of brodalumab in patients with moderate‐to severe plaque psoriasis in the Greek clinical setting (the BrIDGE study)

Rigopoulos,

Tampouratzi,

Angelakopoulos

et al. 2024

Acad Dermatol Venereol

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BackgroundDespite that brodalumab's efficacy and safety have been assessed in randomized clinical trials, real‐life data remain scarce. BrIDGE was an observational, prospective, single‐cohort, multicentre study that recruited patients with moderate‐to severe plaque psoriasis in Greece.ObjectivesThe primary objective was to assess the proportion of patients who achieved Psoriasis Area and Severity Index (PASI)100 after 24 weeks. Other endpoints included: the maintenance of PASI90/100 through to 104 weeks, the short‐term response [PASI75/90/100 and static Physician's Global Assessment (sPGA) 0/1] to brodalumab at 12–16 weeks and time to complete clearance. Moreover, we explored the change in quality of life [Dermatology Life Quality Index (DLQI) 0/1] and adherence to brodalumab.MethodsTwo hundred patients who were initiating treatment with or switching to brodalumab, were recruited. Analyses were conducted using the as observed data and three imputation approaches were also applied for the missing data (last observation carried forward, ‘worst case’ and ‘best case’ scenario). Continuous variables were reported using summary statistics, whereas categorical variables were reported in frequency tables.ResultsBased on the ‘as observed data’, 42.0% of patients achieved PASI100 at Week 24 after 25.9 ± 3.5 weeks and 65% of patients attained PASI100 at Week 104. In total, 70.2%, 47.5% and 32.0% achieved PASI75/90/100, respectively, whereas 72.6% of patients achieved sPGA 0/1, at Weeks 12–16. With respect to sPGA status 82.8%, 89.2% and 92.5% of patients achieved sPGA 0/1 at Weeks 24, 52 and 104, respectively. The time to achieve PASI100 at Weeks 12–16 was 13.7 ± 1.3, 52.1 ± 3.4 weeks at Week 52 and 105.5 ± 4.8 weeks at Week 104. Mean DLQI and Psoriasis Symptom Inventory (PSI) scores decreased by 11.4 ± 7.0 and 15.4 ± 6.5 points from baseline to Week 104, respectively. Adherence to treatment was equal to 98.9%.ConclusionsBrodalumab confers rapid and durable responses, as well as improvements in the quality of life of moderate‐to‐severe psoriasis patients.

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Section: Discussionmentioning

confidence: 79%

Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Real‐world data on the effectiveness of brodalumab in patients with moderate‐to severe plaque psoriasis in the Greek clinical setting (the BrIDGE study)

Rigopoulos,

Tampouratzi,

Angelakopoulos

et al. 2024

Acad Dermatol Venereol

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Management of Moderate to Severe Plaque Psoriasis with Brodalumab in Daily Practice: Real-World Evidence from the LIBERO Study in the Czech Republic

Gkalpakiotis,

Kojanová,

Fialová

et al. 2023

Dermatol Ther (Heidelb)

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Introduction Psoriasis is a chronic, immune-mediated inflammatory skin disease. Despite the availability of several therapies, many patients affected by this disease remain untreated, do not have adequate response, or suffer from treatment-related toxic effects. It has been shown that the interleukin (IL)-17 pathway plays a key role in the immunopathogenesis of psoriasis. Brodalumab, the first human monoclonal IgG2 antibody that selectively binds to subunit A of the human IL-17 receptor, blocking interactions with a number of cytokines of the IL-17 family, has confirmed fast onset of action, high complete clearance rates, and sustained efficacy. Nevertheless, there is only a limited amount of published real-world evidence (RWE) data. Methods This was an open-label, multicenter, real-world, prospective, non-interventional, non-controlled (single-arm) observational study (LIBERO-CZ) assessing the management of moderate to severe psoriasis with brodalumab in daily practice for up to 52 weeks of treatment. Results Fifty-four patients (70.4% male, mean age 46.9 ± 13.4 years, weight 95.6 ± 22.7 kg, disease duration 18.6 ± 12.7 years) were enrolled and included in the final analysis. Forty-nine of the patients completed the study and five discontinued prematurely; 51.8% of all the enrolled patients were biologic-naïve. At baseline, 28% patients were classified as severe (psoriasis area severity index (PASI) ≥ 20). Overall, the mean PASI decreased by 15.6 from 16.1 (± 5.0) at baseline to 0.5 (± 1.2) at the last visit. The primary endpoint of an absolute PASI ≤ 3 at week 12 (as observed analysis) was achieved by 95.9% of patients. The static Physician’s Global Assessment (sPGA) success (defined as clear = 0 and almost clear = 1) at week 52 was achieved by 92.1% of patients. PASI 75, PASI 90, and PASI 100 were achieved by 98.0%, 87.8%, and 75.5% of patients, respectively, after approximately 52 weeks of treatment. The study also recorded very positive results concerning patient-reported outcomes. Conclusions LIBERO-CZ confirms the fast onset and high clearance rates of brodalumab in real life in both biologic-naïve and biologic-experienced patients.

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Single-Centre Real-World Study on Drug Survival and Effectiveness of Brodalumab for Treatment of Psoriasis and Psoriatic Arthritis

2023

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Background Clinical trials have established the efficacy of brodalumab in treatment of psoriasis and psoriatic arthritis. Real-world evidence is needed to fully evaluate the drug. Objective Here we investigate drug survival and clinical effectiveness of brodalumab in patients with psoriasis and psoriatic arthritis in a real-world setting. Methods This was a retrospective single-centre study enrolling patients receiving brodalumab for psoriasis at the Department of Dermatology, Aarhus University Hospital, Denmark. The primary endpoints were drug survival, reasons for discontinuation, percentage of patients achieving a Psoriasis Area and Severity Index (PASI) ≤ 2 and clinical effectiveness against psoriatic arthritis. Results Eighty-three patients were included (mean age 49.2 ± 17.4 years, 59.0% male, 9.6% bio-naïve, mean baseline PASI 10.9 ± 6.9). Twenty-seven patients discontinued treatment primarily due to ineffectiveness and adverse events (AEs). Kaplan–Meier-estimated 1-year drug survival was 65.7%. An absolute Psoriasis Area and Severity Index (PASI) ≤ 2 was achieved by 68.2% of patients at end of follow-up, by 70.0% at weeks 12–17 and by 76.2% after 40–60 weeks of treatment. Neither drug survival nor PASI ≤ 2 was associated with baseline PASI ≥ 10, body mass index ≥ 30, previous treatment with > 2 biologics or other IL-17 inhibitors in particular ( P > 0.05). Psoriatic arthritis remission or partial remission was achieved by 10 out of 18 patients with psoriatic arthritis; treatment failure was reported in 5 patients. Conclusions Brodalumab was effective against psoriasis and psoriatic arthritis in a real-world setting. The drug survival was lower than reported in other real-world settings.

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Real-world clinical outcomes of treatment with brodalumab in patients with moderate-to-severe psoriasis: a retrospective, 24-month experience from four academic dermatology centers in Greece

Cited by 5 publications

References 20 publications

Real‐world data on the effectiveness of brodalumab in patients with moderate‐to severe plaque psoriasis in the Greek clinical setting (the BrIDGE study)

Real‐world data on the effectiveness of brodalumab in patients with moderate‐to severe plaque psoriasis in the Greek clinical setting (the BrIDGE study)

Management of Moderate to Severe Plaque Psoriasis with Brodalumab in Daily Practice: Real-World Evidence from the LIBERO Study in the Czech Republic

Single-Centre Real-World Study on Drug Survival and Effectiveness of Brodalumab for Treatment of Psoriasis and Psoriatic Arthritis

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