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Ankylosing Spondylitis Disease

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Published Date : Nov 2023
Category : Autoimmune Diseases
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Ankylosing Spondylitis (AS) - Chronic Inflammatory Arthritis

Ankylosing Spondylitis (AS) is a chronic, inflammatory disease of the axial spine that mostly affects the back, causing inflammation in the spine. Chronic back pain and liberal spinal stiffness are the most common features of this disease. The characteristics of AS involve the spine, sacroiliac joints, peripheral joints, digits, and entheses. AS leads to impaired spinal spondylitis mobility and results in postural abnormalities. Sometimes patients also experience buttock pain and hip pain. Peripheral arthritis, enthesitis, and dactylitis ("sausage digits") are all allied with AS. Ankylosing spondylitis (AS) commonly presents in people younger than 40, with approximately 80% of patients experiencing first symptoms before age 30, and less than 5% are diagnosed after the age of 45.

The ankylosing spondylitis (AS) causes are unknown. However, there is a correlation between the prevalence of AS and the presence of human leukocyte antigen (HLA)-B27 in each population. Among individuals who are HLA-B27 positive, the prevalence of AS is approximately 5% to 6%. In the United States, the prevalence of HLA-B27 disease varies among cultural groups. According to NCBI survey rates of HLA-B27 prevalence is 7.5% among non-Hispanic Whites, 4.6% among Mexican Americans, and 1.1% among non-Hispanic Blacks. AS is more predominant in men than women.

Enthesitis is the main cause of spondyloarthropathies. Infiltrating immune cells including macrophages and CD4 and CD8 T lymphocytes are a part of this persistent inflammation. The inflammatory process also involves cytokines, including transforming growth factor-β (TGF-β) and tumour necrosis factor-α (TNF-α). At enthesitis-affected areas, they aid in ossification, fibrosis, and inflammation.

Ankylosing spondylitis (AS) symptoms present gradually and without clear early symptoms. The disease primarily shows progressive musculoskeletal, and often extraskeletal, signs and symptoms of ankylosing disease. The rate of disease development differs among individuals.

In addition to skeletal involvement, AS affects various organs other than the joints. These extraarticular manifestations of AS include inflammatory bowel disease which affects up to 50% of people, acute anterior uveitis, seen in 25%-35% of cases, and psoriasis approximately 10% of occurrences.

Industry companies have highlighted discovery in the areas of prevention, diagnosis, and treatment as a critical component of growing their worldwide market share. Consequently, it plays a role in the globalization of product development.

DiseaseLandscape Insights (DLI) helps the stakeholders by offering information about the Ankylosing spondylitis market, as well as informed decisions about medical equipment, treatments, and diagnostic methods. Several new technologies and innovations are also having an impact on the disease market and propelling its growth.

The world's population is becoming more and more affected by Ankylosing spondylitis, which is drastically altering people's quality of life. Currently spondylosis and ankylosing spondylitis conditions would drive industries in the right direction and give new prospects for a range of industry leaders in the field of landscape insights.

Diagnostic Analysis-

All body systems should be examined during the evaluation since AS manifests with extraarticular characteristics and axial and peripheral musculoskeletal complaints. To find or rule out similar disorders that may be connected to AS, such as psoriasis, inflammatory bowel disease, and uveitis, among others, a thorough medical history should be taken.

During the ank spondylitis diagnosis, the patient's history, and physical examination of all body systems, as AS manifests with axial and peripheral musculoskeletal symptoms and extraarticular features. A detailed medical history of a person is attained to identify or rule out associated conditions such as psoriasis, inflammatory bowel disease, and uveitis, among others, that are correlated with AS.

After reviewing symptoms and family history, the healthcare provider performs a physical exam. Healthcare providers order one or more of these tests to help guide diagnosis.

Blood Tests: Blood tests check for the presence of the HLA-B27 gene. About 8% of people of European descent have this gene, but only a quarter of them develop ankylosing spondylitis.

Laboratory testing in ankylosing spondylitis (AS) is typically nonspecific but provides a supportive signal for diagnosis. Approximately 50% to 70% of patients with active AS show raised levels of acute phase reactants, such as erythrocyte sedimentation rate (ESR) and higher C-reactive protein (CRP).

Imaging Scans: Magnetic resonance imaging (MRI) scans detect spine problems earlier than traditional X-rays. Still, sometimes spine X-rays are done to check for arthritis or rule out other problems.

According to the Assessment of Spondyloarthritis International Society (ASAS) axial spondyloarthritis criteria radiographic or magnetic resonance imaging (MRI), is considered a major inclusion criterion for AS.

Plain radiography is the first-line imaging modality in AS, additional imaging with MRI is necessary to detect more subtle abnormalities, such as fatty or inflammatory changes. MRI reveals active inflammatory lesions in the sacroiliac joints. These seem like bone marrow edema (BME) on short tau inversion recovery (STIR) and T2-weighted images with fat suppression. It observed that the presence of BME on MRI also seen in up to 23% of patients with mechanical back pain and 7% of healthy individuals.

Diagnostic Market Players -

Products

Market Players

HLA-B27 PCR Test Kit

Acon Health Care

Discover Series Ankylosing Spondylitis Detection Kit

Mylab Discovery Solutions

TaqMan RT-PCR Detection Kit

Norgen Biotek

gb GENETIC HLA-B*27

Generi Biotech

Zena Max – HLA B27

Advanced Molecular Diagnostics (AMD)

SIGNA™ MRI

GE Healthcare

3 T (Tesla) MRI

Philips

Visart 1.5T

Siemens

Discovery™ MI

Toshiba

 

Treatment Analysis-

There is no proper treatment for ankylosing spondylitis; however, it is managed by various ankylosing spondylitis therapies. The goals of treatment include relieving symptoms and helping maintain proper posture, flexibility, and strength.

In various cases, treatment includes medication and physical therapy. Sometimes, surgery to repair joint damage in people with severe disease.

Medications-

The medical treatment for ankylosing spondylitis includes, over-the-counter non-steroidal anti-inflammatory drugs are first-line pharmaceutical therapy daily, long-term basis. NSAIDs are used in conjunction with or in place of tumor necrosis factor inhibitors (TNF-Is), such as adalimumab, infliximab, or etanercept if they are unable to offer sufficient relief. Biologic drugs target certain immunological signals and interrupt them to reduce or eliminate inflammation. When alternative therapies are not working, Janus kinase (JAK) inhibitors could potentially be recommended. These drugs target certain cells and deliver signals to them that reduce inflammation within the cell.

Corticosteroids have the potential to reduce inflammation and offer some instantaneous pain relief. Usually, they are injected into the joint.

Physical Therapy-

The doctor recommends physical therapy to help relieve pain, strengthen back and neck muscles, in addition improve core and abdominal muscle strength because these muscles provide support to the back, and improve posture, maintain, and improve flexibility in joints.

A physical therapist recommends the best sleeping positions and an exercise program. Because symptoms should not worsen when inactive or at rest, it’s important to stay active and exercise regularly.

Surgery-

If a person has severe joint damage and is unable to participate in daily activities, the doctor recommends surgery. Surgery is not for everyone. Doctors consider the following before recommending surgery: overall health, and condition of the affected bone or joint, risks and benefits of the surgery as well as types of surgery including joint repairs and joint replacements.

Rarely, do some people have surgery to correct or straighten the spine or repair fractures (breaks) in the vertebrae.

Treatment Market Players -

Products

Market Players

Advil

GlaxoSmithKline

Motrin

Johnson & Johnson

Aleve

Bayer HealthCare

Etanercept

Pfizer

Adalimumab

AbbVie Inc.

Prednisone

Jubilant Cadista Pharmaceuticals Inc.

Sulfasalazine

Ipca Laboratories Ltd.

INFLECTRA®

Pfizer

Cimzia®

UCB

SIMPONI®

Janssen Biotech, Inc.

Cosentyx®

Novartis

 

Regulatory Framework –

On 23 January 2023, TGA approved XELJANZ/XELJANZ XR Sponsored by Pfizer Australia Pty Ltd whose active ingredient is Tofacitinib citrate and indicated for Ankylosing Spondylitis (AS) XELJANZ is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded ineffectively to conventional therapy.

Juvenile Idiopathic Arthritis (JIA) - XELJANZ is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis, extended oligoarthritis, and systemic juvenile arthritis without systemic features for six months) and juvenile psoriatic arthritis in patients 2 years of age and older, who have responded incompetently to previous therapy with DMARDs.

DiseaseLandscape Insights analyses the regulatory ecosystem of various nations for AS Spondylitis disease. The market player obtains information on import/export laws across the globe, risk evaluation rules, and inspection from DLI services. Utilizing DLI data, market players prevent and combat the outbreaks of Ankylosing Spondylitis disease.

Clinical Trial Data Assessment -

The crucial role of clinical trials in the practice of evidence-based medicine and health care reform is highlighted by the government's increasing concentration on comparing the effectiveness of studies. One of the main goals of reforming healthcare is achieved by the market participants accurately examining medical therapy with the use of clinical data.

The below table shows the name of the study title ongoing in phases.

Phase 1

Phase 2

Phase 3

Phase 4

A Clinical Trial to Evaluate the Safety, Tolerance and Efficacy of a Cell Injection of Allogeneic UC-MSCs in Patients with Ankylosing Spondylitis

A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects with Active Ankylosing Spondylitis

The Clinical Research of the Traditional Chinese Medicine Bawei Shenqi Pill in the Treatment of the Kidney Yang Deficiency Type of Ankylosing Spondylitis

Efficacy and Safety of Loxoprofen Hydrogel Patch Versus Loxoprofen Tablet in Patients with Ankylosing Spondylitis: a 4-week Randomized, Open-label Study

International Multicentre Comparative Double-Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients with Ankylosing Spondylitis

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of AK111 in Subjects with Active Ankylosing Spondylitis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects with Active Ankylosing Spondylitis

The Clinical Efficacy and the Changes of Immune Cells Subsets with Bioagents in Ankylosing Spondylitis Patients

An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 in Patients with Ankylosing Spondylitis Who Were Treated with Infliximab (Remicade or CT-P13) in Study CT-P13 1.1

The Clinical Research of the Traditional Chinese Medicine Bawei Shenqi Pill in the Treatment of the Kidney Yang Deficiency Type of Ankylosing Spondylitis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Jaktinib in Subjects with Active Ankylosing Spondylitis (AS)

A Multicentre, Double-Blind, and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis

Randomized, Double-blind, Parallel-group, Phase 1 Study

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of The Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (as)

An Open-Label, Multicenter, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Patients with Active Ankylosing Spondylitis (AS)

Efficacy and Safety of Etanercept Dose Reduction in Patients with Ankylosing Spondylitis

A Phase I/II Study of Repeat Intra-articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fc Fusion Gene, in Inflammatory Arthritis Subjects with and Without Concurrent TNF-alpha Antagonists

Anti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing Spondylitis

A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects with Active Ankylosing Spondylitis

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis.

 

Conclusion -

DiseaseLandscape Insights (DLI) gives important stakeholders in the development of novel diagnostic kits and the introduction of treatment solutions a critical piece of information and data. Nonetheless, there is a rise in demand for novel detection methods, other forms of treatment, and the development of vaccines because of growing public knowledge of the illness and outbreaks of scrub typhus.

DiseaseLandscape Insights provides stakeholders with guidance on patient recruiting tactics, regulatory compliance, and the simple setup of clinical trials for innovative therapies. Additionally, DLI helps with the analysis of global regulations, competition in the diagnosis and treatment market, and industry participant expectations for market growth.

This enables market leaders to conduct focused research and development, find sources of raw materials, research contract manufacturing companies, and ensure legal compliance for the company. DiseaseLandscape Insights (DLI) helps all market players have a better foothold in the Ankylosing Spondylitis disease industry.

SUMMARY
VishalSawant
Vishal SawantBusiness Development
vishal@diseaselandscape.com

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