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*For medical professionals only
, nr-axSpA has great difficulties and misunderstandings in diagnosis
.
The 2022 American College of Rheumatology (ACR) Annual Meeting was held
November 10-14, 2022 in Philadelphia, Pennsylvania, USA.
ACR Annual Meeting is the world's largest and most prestigious rheumatology academic conference, attended by more than 16,000 delegates from more than 100 countries every year, and is an important platform
for relevant scholars to obtain the latest and most cutting-edge rheumatology research and clinical application information.
The "Medical Community" media and experts from the Youth Committee of the Rheumatology Branch of the Chinese Medical Association jointly created the live broadcast of "The Youth Committee of the Rheumatology Society Take You to See ACR", so that the majority of colleagues can grasp the essence of
the conference more conveniently.
Diagnosing radiographically negative axial spondyloarthritis (nr-axSpA) has always been a challenge
for clinicians.
This ACR conference reviews the diagnostic myths and problems of nr-axSpA, and discusses the key points
of patient evaluation and nr-axSpA diagnosis in clinical practice.
Professor Wu Xin of Shanghai Changzheng Hospital explained the content of this ACR meeting on nr-axSpA in detail.
Delays in diagnosing diseases are also a very big problem
.
According to data from the United States, the prevalence of nr-axSpA is close to 0.
5 percent, or 1 in 200 people [1,2].
It is estimated that as many as 1.
7 million Americans have nr-axSpA, and about 65 percent of these patients are undiagnosed
.
The onset of symptoms to diagnosis is delayed by an average of 5-8 years, and can be as high as 15 years
.
The patient's diagnosis process may be very tortuous, and before the rheumatology consultation, the patient may seek physiotherapist, chiropractor, plastic surgeon, etc.
for symptomatic treatment, even if the rheumatology department visit, there will still be diagnostic contradictions and delays
.
Reducing the diagnostic delay of nr-axSpA begins with improving the diagnostic capacity of the rheumatologist by assessing key clinical criteria, studying atypical symptoms, reviewing the patient's family history, and listening to the patient's description
.
Another very important aspect is to find reliable cooperation
.
Given the importance of imaging in spondyloarthritis, especially nr-axSpA, collaboration with experienced radiologists is important
.
Multidisciplinary collaboration has become the standard of practice in a variety of diseases, particularly rheumatology and radiology, and establishing ongoing partnerships facilitates the identification and classification
of nr-axSpA patients.
The main clinical symptoms of a 33-year-old woman presenting on her own are diffuse lower back and abdominal pain and peripheral joint pain, which began to develop
slowly five years ago.
The patient's ability to work and daily living is severely affected, accompanied by chronic fatigue
.
• Atypical symptoms are more common in women and include fatigue, widespread pain, and peripheral joint pain
.
Physical examination: diffuse paravertebral, spine, and abdominal pain on palpation, more pronounced
on the left side.
The two fingers of the left hand are slightly swollen and the curvature of the spine is normal
.
Past medical history: fibromyalgia, major depression, irritable bowel syndrome, and mild hypertension
.
Drug history: duloxetine and lisinopril
.
Family history: father with hypertension, coronary heart disease, mother with uveitis, sister with long-term gastrointestinal discomfort (uncertain inflammatory bowel disease or irritable bowel syndrome).
• Women with nr-axSpA are more likely than men to have a family history, and a review of the patient's family history may be helpful
.
Haematology and x-rays: clear sacroiliac joint space without significant sacroiliac joint injury
.
C-reactive protein was mildly elevated (13.
5mg/L), HLA-B27 negative, and erythrocyte sedimentation rate was 21mm/hour
.
• Diagnosis of nr-axSpA in HLA-B27-negative patients relies on positive sacroiliac joint injury on MRI
.
MRI evaluation of nr-axSpA is challenging and relies on the expertise of radiologists
.
Based on the first radiologist's assessment, the imaging results were not clear
.
However, according to the interpretation of a second radiologist, bone marrow edema was manifested in the hyperintense area of the STIR sequence, suggesting sacroiliitis
.
Certolizumab is the first and only TNF inhibitor
approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of nr-axSpA.
Since its launch in 2008, certolizumab has been approved by the FDA for 6 indications, and has been used for more than 1 million patient years
worldwide.
C-axSpAnd is a landmark study to investigate the efficacy and safety of certolizumab in patients with active nr-axSpA [3].
Background medications for placebo and drug groups, including nonsteroidal anti-inflammatory drugs (NSAIDs), topical hormones, disease-modifying antirheumatic drugs (DMARDs), or central analgesics
, were allowed in the study.
The primary endpoint was 52 weeks of ASDAS-MI
.
A total of 317 patients aged ≥ 18 years with adult-onset active axial spondyloarthritis ≥ 12 months were randomized to either certolizumab (n=159) or placebo (n=158)
on a 1:1 basis.
During treatment, there was a statistically significant difference
in ASDAS-MI between the two groups at week 2.
Of the patients who achieved ASDAS-MI remission at week 12, 35% were in the setolizumab group and only 6%
in the placebo group.
A 47% ASDAS-MI response was achieved in the setolizumab group at week 52, and 37% of patients in the setolizumab group at week 156 maintained an ASDAS-MI response (Figure 1).
There was a statistically significant difference in ASAS40 between the two groups, with a response rate of 48% in ASAS 40 at week 12 and 11% in the placebo group, 57% in the 52nd week setolizumab group, and 54%
at week 156.
In addition, patients in the certolizumab group experienced reduced BASDAI and decreased nocturnal spinal pain at weeks 12, 52, and 156
.
New safety signals
were not reported during the Security Follow-up Extension (SFE) phase.
Figure 1 The primary endpoint of the C-axSpand study, ASDAS-MI remission
, nr-axSpA has great difficulties and misunderstandings in diagnosis
.
The 2022 American College of Rheumatology (ACR) Annual Meeting was held
November 10-14, 2022 in Philadelphia, Pennsylvania, USA.
ACR Annual Meeting is the world's largest and most prestigious rheumatology academic conference, attended by more than 16,000 delegates from more than 100 countries every year, and is an important platform
for relevant scholars to obtain the latest and most cutting-edge rheumatology research and clinical application information.
The "Medical Community" media and experts from the Youth Committee of the Rheumatology Branch of the Chinese Medical Association jointly created the live broadcast of "The Youth Committee of the Rheumatology Society Take You to See ACR", so that the majority of colleagues can grasp the essence of
the conference more conveniently.
Diagnosing radiographically negative axial spondyloarthritis (nr-axSpA) has always been a challenge
for clinicians.
This ACR conference reviews the diagnostic myths and problems of nr-axSpA, and discusses the key points
of patient evaluation and nr-axSpA diagnosis in clinical practice.
Professor Wu Xin of Shanghai Changzheng Hospital explained the content of this ACR meeting on nr-axSpA in detail.
Challenges in nr-axSpA diagnostics
Diagnosis is a challenge
for nr-axSpA.
In spondyloarthropathy, low back pain is the main symptom and the main symptom
of nr-axSpA.
About 80% of adults are affected by low back pain, and chronic low back pain affects 13% of adults, but axial SpA accounts for less than 5%
of common symptoms of chronic lower back pain.
Therefore, it is very challenging to find uncommon causes among common symptoms
.
There are some misunderstandings
in the diagnosis of nr-axSpA.
The sensitivity and specificity of spondyloarthritis serological inflammatory responses are not high, and previous studies have found that 23% of patients with nr-axSpA are HLA-B27 negative
.
Therefore, for patients with undiagnosed nr-axSpA, elevated inflammatory factors and positive HLA-B27 are not necessary criteria
for the diagnosis of nr-axSpA.
At present, there are no verified diagnostic criteria for nr-axSpA, and spondyloarthropathy, including many rheumatic immune diseases, is classified according to patients with similar symptoms, classified into axial SpA or nr-axSpA, but this classification standard is not suitable for diagnosis
.
Imaging is another challenge
in diagnosing disease.
The usefulness of imaging in spondyloarthritis is very important, but sometimes there are many problems
in interpreting imaging results.
Different people or the same person may interpret the results differently
at different times.
Clinical recommendations for MRI for nr-axSpA are not consistent
.
In the 2019 ACR guidelines, MRI is not recommended as a routine diagnostic and follow-up test, and should only be considered
when the evaluation of the means commonly used in the differential diagnosis of disease is difficult.
In addition
, clinicians have a low level of awareness of nr-axSpA.
In addition to rheumatologists, doctors in other disciplines may miss a diagnosis
if they have limited knowledge of rheumatic immunological diseases, such as some extra-articular symptoms of spondyloarthropathy - iridocyclitis, psoriasis lesions, and enteritis.
Delays in diagnosing diseases are also a very big problem
.
According to data from the United States, the prevalence of nr-axSpA is close to 0.
5 percent, or 1 in 200 people [1,2].
It is estimated that as many as 1.
7 million Americans have nr-axSpA, and about 65 percent of these patients are undiagnosed
.
The onset of symptoms to diagnosis is delayed by an average of 5-8 years, and can be as high as 15 years
.
The patient's diagnosis process may be very tortuous, and before the rheumatology consultation, the patient may seek physiotherapist, chiropractor, plastic surgeon, etc.
for symptomatic treatment, even if the rheumatology department visit, there will still be diagnostic contradictions and delays
.
Reducing the diagnostic delay of nr-axSpA begins with improving the diagnostic capacity of the rheumatologist by assessing key clinical criteria, studying atypical symptoms, reviewing the patient's family history, and listening to the patient's description
.
Another very important aspect is to find reliable cooperation
.
Given the importance of imaging in spondyloarthritis, especially nr-axSpA, collaboration with experienced radiologists is important
.
Multidisciplinary collaboration has become the standard of practice in a variety of diseases, particularly rheumatology and radiology, and establishing ongoing partnerships facilitates the identification and classification
of nr-axSpA patients.
Case analysis
The main clinical symptoms of a 33-year-old woman presenting on her own are diffuse lower back and abdominal pain and peripheral joint pain, which began to develop
slowly five years ago.
The patient's ability to work and daily living is severely affected, accompanied by chronic fatigue
.
• Atypical symptoms are more common in women and include fatigue, widespread pain, and peripheral joint pain
.
Physical examination: diffuse paravertebral, spine, and abdominal pain on palpation, more pronounced
on the left side.
The two fingers of the left hand are slightly swollen and the curvature of the spine is normal
.
Past medical history: fibromyalgia, major depression, irritable bowel syndrome, and mild hypertension
.
Drug history: duloxetine and lisinopril
.
Family history: father with hypertension, coronary heart disease, mother with uveitis, sister with long-term gastrointestinal discomfort (uncertain inflammatory bowel disease or irritable bowel syndrome).
• Women with nr-axSpA are more likely than men to have a family history, and a review of the patient's family history may be helpful
.
Haematology and x-rays: clear sacroiliac joint space without significant sacroiliac joint injury
.
C-reactive protein was mildly elevated (13.
5mg/L), HLA-B27 negative, and erythrocyte sedimentation rate was 21mm/hour
.
• Diagnosis of nr-axSpA in HLA-B27-negative patients relies on positive sacroiliac joint injury on MRI
.
MRI evaluation of nr-axSpA is challenging and relies on the expertise of radiologists
.
Based on the first radiologist's assessment, the imaging results were not clear
.
However, according to the interpretation of a second radiologist, bone marrow edema was manifested in the hyperintense area of the STIR sequence, suggesting sacroiliitis
.
Combined with the patient's condition, back pain ≥ 3 months, age of onset < 45 years, X-ray did not show sacroiliitis, MRI showed sacroiliitis, combined with ≥ 1 SpA feature and the clinical judgment of the specialist, the patient met the classification diagnosis and clinical judgment
of nr-axSpA.
Classic clinical study of certolizumab
Certolizumab is the first and only TNF inhibitor
approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of nr-axSpA.
Since its launch in 2008, certolizumab has been approved by the FDA for 6 indications, and has been used for more than 1 million patient years
worldwide.
C-axSpAnd is a landmark study to investigate the efficacy and safety of certolizumab in patients with active nr-axSpA [3].
Background medications for placebo and drug groups, including nonsteroidal anti-inflammatory drugs (NSAIDs), topical hormones, disease-modifying antirheumatic drugs (DMARDs), or central analgesics
, were allowed in the study.
The primary endpoint was 52 weeks of ASDAS-MI
.
A total of 317 patients aged ≥ 18 years with adult-onset active axial spondyloarthritis ≥ 12 months were randomized to either certolizumab (n=159) or placebo (n=158)
on a 1:1 basis.
During treatment, there was a statistically significant difference
in ASDAS-MI between the two groups at week 2.
Of the patients who achieved ASDAS-MI remission at week 12, 35% were in the setolizumab group and only 6%
in the placebo group.
A 47% ASDAS-MI response was achieved in the setolizumab group at week 52, and 37% of patients in the setolizumab group at week 156 maintained an ASDAS-MI response (Figure 1).
There was a statistically significant difference in ASAS40 between the two groups, with a response rate of 48% in ASAS 40 at week 12 and 11% in the placebo group, 57% in the 52nd week setolizumab group, and 54%
at week 156.
In addition, patients in the certolizumab group experienced reduced BASDAI and decreased nocturnal spinal pain at weeks 12, 52, and 156
.
New safety signals
were not reported during the Security Follow-up Extension (SFE) phase.
Figure 1 The primary endpoint of the C-axSpand study, ASDAS-MI remission
The RPID-axSpA study is a study over 4 years in patients with axSpA [4,5].
The main variable was ASAS20 remission at week 12, with significantly higher outcomes in the 200 mg and 400 mg groups than in the placebo group (58%, 64%, and 38%, respectively
).
Secondary endpoint: ASAS40 achieved significant clinical remission
at weeks 12 and 24 compared with placebo in the 200 mg and 400 mg groups.
In terms of sustained remission, ASAS40 remained up to 204 weeks and still achieved a 43% response (Figure 2).
In addition, 95.
5% of treated nr-axSpA patients did not transition to ankylosing spondylitis for more than 4 years, and only 2 (4.
5%) had radiographic conversion to ankylosing spondylitis
.
Figure 2 RPID-axSpA studies ASAS40 remission
The above two studies have shown that certolizumab can quickly relieve symptoms and have a sustained improvement effect, especially to maintain the radiographic progression of nr-axSpA patients and avoid the transformation
to ankylosing spondylitis.
Professor Wu Xin
• Member of the Youth Committee of the Internal Medicine Specialty Branch of Shanghai Medical Association
• Deputy Head of the Vasculitis Group, Rheumatology Specialty Branch of Shanghai Medical Association, Member and Secretary of the Psychosomatic Collaborative Group, Psychosomatic Medicine Branch of Chinese Medical Association, Member of the 2nd Rheumatology and Immunology Professional Committee of Cross-Strait Medical and Health Exchange Association, Member of Precision Medicine Branch of China Pharmaceutical Biotechnology Association staff• Studied at
the University of Queensland, Australia.
He has successively won the National Natural Science Foundation of China Youth Program, the National Natural Science Foundation of China General Project, the Second Military Medical University "Outstanding Young Scholars" Fund, and the main academic backbone of the 973 Project
.
He has won the Outstanding Speaker Award of the 3rd China-Japan-Korea Rheumatology Summit Forum in the Asia-Pacific Region, the first prize of the Excellent Paper of the 2nd and 3rd Shanghai Rheumatology Annual Conference, the first prize of the Shanghai Medical Science and Technology Award, and the first prize of the Shanghai Science and Technology Progress Award
[1]Reveille, John D.
Am J Med Sci.
2011 Apr; 341(4):284-6.
[2] Baraliakos, X, and J Braun.
RMD Open.
2015 Aug 15; 1(Suppl 1):e000053.
[3] Deodhar, Atul et al.
Arthritis Rheumatol.
2019 Jul; 71(7):1101-1111.
[4] Landewé, R et al.
Ann Rheum Dis.
2014 Jan; 73(1):39-47.
[5]van der Heijde, Désirée et al.
Rheumatology (Oxford).
2017 Sep 1; 56(9):1498-1509.
