-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
For medical professionals only
The full text of the ASAS-EULAR-axSpA guideline update was published, and IL-17A inhibitors were successfully "on the ground"!
After six years, the International Association for the Evaluation of Spondyloarthritis (ASAS)/European Union Against Rheumatism (EULAR) has updated
the guidelines for the management of axial spondyloarthritis (axSpA) (hereinafter referred to as the new ASAS-EULAR-axSpA management guidelines).
At this year's EULAR 2022 Annual Academic Conference, Dr.
Sofia Ramiro introduced the main content and update points of the guide to a global audience (click to view related reports).
In October, the full text of the new ASAS-EULAR-axSpA management guidelines was officially published in the Yearbook of Rheumatology [1].
Compared with the oral presentation at the annual academic conference, what other details are worth paying attention to in the full text of the guide? What are the similarities and differences compared with the current guidelines/norms in China? The medical community specially invited Professor Zeng Xiaofeng of Peking Union Medical College Hospital and Professor Gu Jieruo of the Third Affiliated Hospital of Sun Yat-sen University to comprehensively interpret the new version of the guidelines and deeply analyze the treatment strategy
of axSpA.
Prof.
Zeng Xiaofeng: Proficient in evaluation tools to initiate biologics treatment
early As an inflammatory disease, monitoring of disease activity is important in the diagnosis and treatment of axSpA
.
The new ASAS-EULAR-axSpA management guidelines follow the recommendation of 6 years ago to prioritize the use of ankylosing spondylitis disease activity scores (ASDAS) to monitor axSpA disease activity
.
The new ASAS-EULAR-axSpA management guidelines believe that compared with BASDAI, ASDAS contains C-reactive protein (CRP) as an objective standard to measure inflammation, while BASDAI can only be evaluated from the patient's perspective, and ASDAS score has a longitudinal correlation with the formation of ligamentous osteophytes in subsequent patients, and the high score of ASDAS is closely related to the radiological progression of patients.
This assessment tool better reflects the patient's long-term prognosis
.
Therefore, ASDAS is more objective and feasible
in daily clinical practice.
The new ASAS-EULAR-axSpA management guidelines also propose that high disease activity should be based on ASDAS≥2.
1 criteria, and that BASDAI≥4 should only be used as an alternative
if ASDAS≥2.
1 criteria are not possible.
Although much space has been spent comparing ASDAS and BASDAI, the new ASAS-EULAR-axSpA management guidelines also emphasize that disease activity should not only be judged by scoring, but should also be supplemented by the opinion
of a rheumatologist 。 A comprehensive assessment of the patient – including initial assessment and annual review – is required during treatment, and these assessments require a rheumologist to coordinate a multidisciplinary team to achieve the therapeutic goals
of controlling symptoms and inflammation, preventing progressive structural damage, preserving or normalizing function, and social engagement, and maximizing health-related quality of life.
Figure 1 Treatment goals (general principle B) proposed by the ASAS-EULAR axSpA guideline It
is worth noting that the new ASAS-EULAR-axSpA management guideline proposes a total of 2 significant updates.
Both updates were associated with interleukin-17 (IL-17) inhibitors:
- TNF inhibitors, IL-17A inhibitors, or Janus kinase (JAK) inhibitors should be considered for patients with persistently high disease activity despite conventional care, starting with TNF inhibitors or IL-17A inhibitors
in current practice. - After failure of the first biologic agent (bDMARD) or targeted synthetic antirheumatic drug (tsDMARD), another bDMARD (TNF inhibitor or IL-17A inhibitor)
should be switched immediately.
Figure 2 TWO NOTABLE UPDATES TO THE ASAS-EURAR AXSpA guidelines (recommendations 9, 12)
Specifically, Recommendation 9 changed the phrase "TNF inhibitors are usually used first in current practice" to "TNF inhibitors or IL-17A inhibitors are usually used first in current practice"
in the old guidelines.
This also means that the role of IL-17A inhibitors in axSpA therapy is getting more and more attention
.
Professor Gu Jieruo: How do IL-17A inhibitors "get up"? Also look at real-world data!
The working group on the new ASAS-EULAR-axSpA management guidelines made it clear that the update of Recommendation 9 is
based on long-term efficacy and safety data on IL-17A inhibitors.
As the world's first fully human IL-17A inhibitor, sekukizumab has been on the market globally for 7 years, and in these 7 years, evidence has accumulated, contributing to the improvement
of its clinical status.
Data from randomized controlled studies (RCTs) suggest that sekukumab significantly improves pain and fatigue symptoms in AS patients at weeks 1 and 4, regardless of their baseline CPR level and treatment with TNF inhibitors [2]; With long-term treatment of AS, response to sekukizumab was consistently high, with 78.
6 percent maintaining an ASAS 20 response at year 5 [3
].
Compared with rigorously designed RCTs, real-world study (RWS) data are more able to confirm the efficacy and safety of
sekukizumab in real clinical practice.
Data analysis of real patient data based on web-based cross-sectional surveys published in 2019 showed that 99 percent and 97 percent of patients were satisfied with the degree and speed of symptom improvement after sekukizumab treatment, and 93 percent were tolerated by side effects, if any, [4].
RWS, published in 2022 investigating the long-term safety of sekukumumab for more than five years in patients with moderate to severe plaque psoriasis, psoriatic arthritis and AS (comprehensive summary clinical trials and updates of post-marketing surveillance data), included 28 clinical studies that fully evaluated the safety of
sekukumab 。 The results of the analysis showed that the long-term safety profile of sekukizumab in the treatment of AS patients was good, the incidence of adverse reactions was low, the most common adverse event was upper respiratory tract infection, and there was no significant correlation
between the use of sekukumab and serious adverse events.
Real-world studies have confirmed that sekukizumab has both efficacy and safety in the treatment of AS, so the "upper position" of IL-17A inhibitors in the new version of the guidelines is natural
.
JAK inhibitors, which are also mentioned in the new ASAS-EULAR-axSpA management guidelines, have not accumulated evidence-based evidence and long-term safety data outside RCTs due to their short marketing time, and have not yet received equivalent recommendations
.
In addition, the Rheumatology Branch of the Chinese Medical Association has also updated the "Standards for the Diagnosis and Treatment of Ankylosing Spondylitis" [5] (hereinafter referred to as the "2022 Guidelines")
this year.
By comparing the similarities and differences of domestic and foreign guidelines/norms, combined with rich evidence-based evidence at home and abroad, we can more comprehensively understand and master AS treatment strategies
.
Similar to the new ASAS-EULAR-axSpA management guidelines, the 2022 Code also considers that nonsteroidal anti-inflammatory drugs (NSAIDs) should be the drug of choice for patients with AS, and bDMARDs should be considered for patients with AS who remain active despite NSAIDs
。 Both the new ASAS-EULAR-axSpA management guidelines and the 2022 Code clearly define the timing of bDMARD use – at least 2 NSAIDs treated for more than 4 weeks with unresolved symptoms and/or adverse effects
.
The 2022 Code also clearly states that "patients with AS who remain active after NSAIDs treatment should consider the use of biological DMARDs, and the current drug options include TNF-α inhibitors and IL-17 inhibitors" [5].
This also shows that IL-17A inhibitors have been approved by guidelines and are on the front line
of biological therapy together with TNF inhibitors, both at home and abroad.
Figure 3 Summary of recommendations for biologics in the 2022 specification:
Six years have passed since the last edition of
the ASAS-EULAR-AXSpA Management Guide
。 In the past 6 years, IL-17A inhibitors have been approved for AS indications in many countries around the world, and thus have accumulated rich RWS data
.
These data, combined with rigorously designed RCT data, were eventually recognized by the ASAS-EULAR-axSpA Management Guidelines Development Working Group, placing IL-17A inhibitors in the first line of biotherapeutics
.
At the same time, the 2022 edition of the "Ankylosing Spondylitis Diagnosis and Treatment Specification" formulated by the Rheumatology Branch of the Chinese Medical Association is synchronized with international guidelines, further confirming the clinical status of IL-17A inhibitors.
Expert
Professor Zeng Xiaofeng
- Director of the National Clinical Research Center for Skin and Immune Diseases
- Director of the Department of Rheumatology and Immunology of Peking Union Medical College Hospital, doctoral student/postdoctoral supervisor
- Tenured Professor of Peking Union Medical College
- Member of the Beijing Municipal Committee of the Chinese People's Political Consultative Conference and recipient of special allowance of the State Council
- Former Vice President of the Asia-Pacific Union of Rheumatological Societies (APLAR).
- Chief scientist of the "13th Five-Year Plan" National Key R&D Program
- Member of the writing team of the application guidelines for the national key R&D plan projects of the 14th Five-Year Plan
- Standing Director of Chinese Medical Doctor Association and President of Rheumatology and Immunology Branch
Professor Gu Jieruo
- Professor of Department of Rheumatology and Immunology, The Third Affiliated Hospital of Sun Yat-sen University
- Director of Guangdong Clinical Research Center for Immune Diseases
- Expert of the Special Contribution Allowance of the State Council
- Recipient of the National Natural Science Foundation of China Outstanding Youth Fund
- Winner of the honorary title of "National Famous Doctor • Outstanding Achievement"
- Leading medical talent in Guangdong Province
- Member of the International Expert Committee on Spondyloarthritis
- Vice Chairman of Rheumatology and Immunology Specialist Branch of Chinese Medical Doctor Association
References:
[1] Ramiro S,et al.
Ann Rheum Dis.
2022; ard-2022-223296.
[2] Deodhar A,et al.
Clin Exp Rheumatol.
2019; 37(2):260-269.
[3] Baraliakos X,et al.
RMD Open.
2019; 5(2):e001005.
Published 2019 Sep 3.
[4] Magrey M,et al.
Drugs Real World Outcomes.
2019; 6(2):83-91.
[5] HUANG Feng, et al.
Chinese Journal of Internal Medicine,2022,61(8):893-900.
This article is only for providing scientific information to healthcare professionals and does not represent the position of
the platform.
