With Dr. Miroslav Nečas, Ph.D., on the conclusions of the recent consensus of the expert panel on the practice of biological treatment of psoriasis
This February, an expert consensus on the use of bimekizumab in the treatment of psoriasis and psoriatic arthritis (PsA) was published based on a literature review of 102 articles, from which 19 relevant publications were selected. A panel of 9 dermatologists then voted to accept 14 consensus statements and recommendations, 12 of which received an 'A' grade, one a 'B' grade, and one a 'C' grade. We discuss key conclusions and recommendations with Dr. Miroslav Nečas, Ph.D., from the 1st Department of Dermatovenereology at MU and St. Anne's Faculty Hospital in Brno.
How important is this consensus for Czech dermatology? Are its conclusions in line with current recommendations for the treatment of psoriasis and your real-world experience?
Psoriasis is a chronic inflammatory disease affecting not only the skin but often the joints as well. It can also be associated with a number of serious comorbidities. Bimekizumab represents the first monoclonal antibody targeted not only against interleukin 17A but also against IL-17F, which significantly enhances the efficacy of this biologic.
The consensus of the expert panel summarizes the current knowledge about this drug and provides recommendations for its use in the context of existing treatment options for severe psoriasis. Current recommendations, or treatment goals, include achieving a PASI 90−100 score (meaning complete or nearly complete clearance of psoriasis), an absolute PASI ≤ 2, and a DLQI score (which is an indicator of quality of life) < 2. We are able to achieve these goals in the vast majority of cases using bimekizumab, and our real-world experience confirms this.
Which recommendations from the consensus have 'A' grade evidence strength?
This includes statements that there are still unmet needs in the treatment of psoriasis, that bimekizumab is highly effective in treating moderate to severe psoriasis, and is more effective and faster-acting in head-to-head studies than secukinumab, adalimumab, or ustekinumab. The efficacy of bimekizumab is long-lasting and does not diminish with treatment duration. Even after discontinuation or interruption, its effects persist (the median time to psoriasis relapse is about 32 weeks). The safety profile of bimekizumab is similar to other biologics, except for the occurrence of oropharyngeal candidiasis. It is effective in treating all forms of psoriatic arthritis. The optimal dosing is 320 mg every 4 weeks up to week 16 and then every 8 weeks; in indicated cases, dosing every 4 weeks can continue after week 16. Bimekizumab can be used as a first-line treatment for moderate to severe psoriasis with or without psoriatic arthritis.
What about unmet needs in psoriasis treatment? What does bimekizumab bring in this regard, especially with its targeting of interleukins 17A and 17F?
Despite the relatively wide range of treatment options for severe psoriasis available today, particularly concerning biological treatments, there are still gaps. First, there's accessibility—not all patients indicated for biological treatment actually get it, or they get it late. Furthermore, biologics can lose their effect over time, complications may arise, or the patient might not tolerate the treatment. In this regard, bimekizumab provides a clear advantage by being effective even after several previous biologics have failed, and this also applies to obese, polymorbid, or otherwise complicated patients.
As mentioned, bimekizumab has shown high efficacy in treating psoriasis. Does achieving high PASI scores, such as 90–100, reflect in your practice?
In psoriasis treatment, it shows truly unique results: In studies, PASI 100 is achieved by about 70% of patients and PASI 90 by around 90% of patients. These are results no other biologic for psoriasis therapy can boast of. I can confirm this from my own experience—all my patients, most of whom had previously failed multiple biologics, responded quickly and convincingly to bimekizumab treatment.
Bimekizumab has been compared with other targeted drugs. How does it stand, whether it's targeting IL-17, IL-23, or IL-12/23... And are there any similar molecules available or on the horizon?
In direct head-to-head studies, bimekizumab proved to be more effective and faster-acting than secukinumab (IL-17 inhibitor), adalimumab (anti-TNF-α), or ustekinumab (IL-12/23 blocker). In terms of IL-23 inhibitors, meta-analyses also show that bimekizumab is somewhat more effective. In the realm of new substances, the IL-23 inhibitor mirikizumab did not offer greater efficacy in treating psoriasis compared to other biologics in this group and will likely be directed more towards gastroenterological indications.
Research is now focusing on so-called small molecules, such as tyrosine kinase inhibitors (TYK), like deucravacitinib (a selective TYK2 inhibitor), which has already received approval for the treatment of moderate to severe psoriasis in adults, or on inhibitors of retinoic acid receptors (RORγt). These receptors function as transcription factors essential for the development and proper function of TH17 lymphocytes.
What dose of bimekizumab has proven best and what data is available for long-term administration?
Phase II studies showed that during 12 weeks, patients taking 320 mg of bimekizumab every 4 weeks had the highest clinical responses (PASI 90 or IGA 0−1) compared to other dosing regimens. In phase III clinical trials, patients received 320 mg of bimekizumab every 4 weeks for 16 weeks and then every 4 weeks or every 8 weeks for 56 weeks. More patients on the 8-week dose achieved PASI 90 (91.0 vs. 86.8%) and PASI 100 (83.0 vs. 70.8%) compared to those on the 4-week dose. A long-term study evaluating results for over 3 years of therapy showed that the 320 mg dose every 4 weeks for 16 weeks and then every 8 weeks had consistently good treatment responses and was in line with outcomes for all patients treated with bimekizumab.
For patients with psoriasis and psoriatic arthritis, the optimal dosing of bimekizumab is not yet definitively established, but study data supports dosing every 4 weeks.
Are candida infections, which are among the most common side effects of bimekizumab treatment, manageable in practice? And do these side effects tend to diminish or worsen with prolonged use?
Data from clinical trials with bimekizumab show that the drug is very well tolerated, but there was an increased occurrence of mild to moderate oral candidiasis. The frequency of candidiasis varied in phase II and III studies from 4 to 13.4%. The occurrence decreased with the duration of bimekizumab treatment. Most cases involved only a single episode of candidiasis. Among our patients, we noted a single case of oral candidiasis about 2 months after starting bimekizumab treatment. It was a mild form that resolved promptly with systemic antifungals and has not recurred with continued bimekizumab treatment for six months now.
When and to whom should bimekizumab be administered, and who should be more cautious? I'm particularly interested in patients with comorbidities...
Treatment with bimekizumab is especially suitable for those with extensive and severe psoriasis and also for cases where we need a quick treatment effect for various reasons. Additionally, for patients who have already received biological treatment but have lost their efficacy (including several different biologics, including those in the same class, such as anti-IL-17), as well as for obese individuals or patients with difficult-to-treat areas like the scalp, palmoplantar psoriasis, or nails. Caution is definitely warranted for patients with active bowel disease types like IBD and also for immunosuppressed individuals or those with recurrent severe infections.
Based on the above, how do you personalize psoriasis treatment? To what extent can you consider the wishes and expectations of the particular patient?
In choosing treatment for a patient, it's always necessary to decide whether biological treatment is suitable and if they meet the criteria for its initiation (also considering insurance reimbursement criteria). When selecting a particular biologic, the characteristics of the drug are taken into account, such as its mechanism of action, efficacy, speed of onset, long-term effect, or potential loss of efficacy including potential immunogenicity. And of course, the safety of the treatment is crucial, meaning potential side effects of the drug. From the patient's perspective, we consider the type and location of psoriasis (including involvement of difficult-to-treat areas) and comorbidities, including higher body weight. We also take into account the patient's preferences and the overall impact on their quality of life, though this is neither the main nor the only criterion in treatment selection.
In conclusion, please summarize the current quality of life for patients treated with bimekizumab...
To assess the quality of life of patients with dermatological conditions, we most commonly use the DLQI questionnaire, which scores from 0 to 30, where 30 indicates the worst quality of life and 0 means no negative impact of the disease on the patient's quality of life. Studies with bimekizumab achieved a DLQI of 0−1, meaning no or minimal negative impact of psoriasis on quality of life, in about 80% of patients by week 8 of treatment, and this proportion further increased to around 90%. This indicates that bimekizumab treatment significantly improves the quality of life for patients with psoriasis treated with this drug.
Dr. Andrea Skálová
editorial team, proLékaře.cz
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