Take the Guess Work Out of Biologic Rheumatoid Arthritis Choice

April 9, 2024

Rheumatoid arthritis (RA) is a chronic inflammatory disorder that not only affects the joints but can exert systemic influence, potentially impacting various body systems. The journey through RA treatment is unique for each individual, necessitating a personalized approach. Enter precision medicine for rheumatoid arthritis—the practice of tailoring treatment to the individual characteristics of each patient.

Today we delve deep into how molecular signature testing is revolutionizing treatment decision-making in RA.

Understanding Molecular Signature Testing

Within precision medicine for rheumatoid arthritis, molecular signature testing is emerging as a novel way we can identify whether individuals might benefit from certain biologic medications. The molecular signature is essentially a unique ‘barcode’ of gene expression within an individual’s immune cells. This can predict the body’s response to different treatments.

The Study At Hand: A Pivotal Discovery

Recently, a critical study titled “Patient outcomes improve when a molecular signature test guides treatment decision-making in rheumatoid arthritis,” published in the Expert Review of Molecular Diagnostics, has provided substantial evidence supporting the integration of molecular signature testing in managing RA.

In the study, researchers elucidated the role of a specific test—the Molecular Signature Response Classifier (MSRC). The MSRC is designed to predict whether patients with RA will respond to tumor necrosis factor inhibitor (TNFi) therapies, a common class of biologic drugs used in treatment. These medications include Enbrel, Humira, Cimzia, Simponi, and Remicade as well as their biosimilar equivalents.

Unlocking Personalized Treatment Strategies

Biologic medications, which target specific components of the immune system, have transformed the landscape of RA treatment. However, the response to these drugs can vary significantly among patients—a challenge that precision medicine for rheumatoid arthritis seeks to address.

The Molecular Signature Response Classifier (MSRC) test functions as a sophisticated investigative tool employed to decipher the intricate workings of your immune system, particularly in relation to rheumatoid arthritis (RA). At its core, the MSRC examines the patterns of gene expression, which can be envisioned as the “on” or “off” switches of genes within your immune cells. These patterns can provide crucial insights into your body’s unique response to specific medications, specifically tumor necrosis factor inhibitors (TNFis)—a class of biologic drugs frequently utilized in RA treatment.

By measuring these gene expressions, the MSRC can predict with a remarkable degree of accuracy whether your body is likely to respond favorably to TNFis, thus avoiding the potential trial and error associated with medication effectiveness. This personalized approach not only guides your healthcare provider in selecting the most appropriate treatment for your condition but also reflects a conscientious and empathetic stride towards optimizing your healthcare experience, minimizing unnecessary interventions and focusing on treatments that align with your body’s individual genetic makeup.

The study showcases how MSRC testing can predict the efficacy of TNFi medications for individuals with RA. This innovative approach posits that using a patient’s molecular signature could improve rates of remission and help in selecting the most fitting biologic therapy.

Simply put, it seeks to take the guess work out of biologic therapy choice.

The Research Outcomes: A Patient-Centric View

Improving Patient Journeys

By analyzing a pooled cohort of patients who were subjected to MSRC testing to guide biologic therapy selections, the study demonstrated a significant improvement in patient outcomes, notably in remission rates and achieving low disease activity. Specifically, patients in the MSRC-tested arm achieved higher proportions of clinical disease activity index (CDAI) low disease activity or remission (CDAI-LDA/REM) and remission alone (CDAI-REM), compared to those in the external control group, over a six-month period. Furthermore, a notable improvement was observed in minimally important differences (MID) in CDAI scores, indicating a meaningful reduction in disease activity from baseline.

The Promise of Precision Medicine in Action

Each RA patient’s battle is distinct, often filled with trials and adjustments in treatment regimens. The clear message from this research is that precision medicine for rheumatoid arthritis, epitomized by molecular signature testing, can facilitate a more targeted treatment approach—a leap forward from the one-size-fits-all strategy.

What This Means for You: Precision Medicine’s Role

Contemplating Biologic Treatment Options

If you are considering initiating biologic therapy or are reevaluating your current regimen, precision medicine for rheumatoid arthritis offers a scientific beacon. By assessing your unique molecular signature, clinicians can better forecast which therapy aligns with your body’s intrinsic biology.

Precision Medicine for Rheumatoid in Clinical Practice

The clinical implications are considerable. The integration of molecular testing in treatment planning could not only enhance patient outcomes but potentially streamline the therapeutic trajectory, reducing the trial-and-error approach that many patients and their doctors face.

Collecting the Pieces: The Broader Implications

Beyond Individual Outcomes

Precision medicine’s implications extend beyond individual patient care not only for rheumatoid arthritis but also other autoimmune conditions such as multiple sclerosis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, etc. This paradigm has the potential to enhance healthcare resource utilization by optimizing medication selection and reducing the economic burden of ineffective treatments.

Concluding Thoughts: The Precision Medicine Landscape

As we navigate the intricate landscape of RA, molecular signature testing stands as a promising lighthouse, guiding us towards safe harbors of effective treatment options. By embracing the tailored approach that precision medicine for rheumatoid arthritis offers, we can look forward to a future where patients are not only treated but understood on a molecular level.

Call to Action: Partner with Precision

If you are at a crossroads in your RA treatment journey, consider discussing molecular signature testing with your healthcare provider. It is a step towards a personalized treatment plan crafted with your unique genetic makeup in mind, offering the potential for improved outcomes and quality of life.

References

Molecular Signature Testing: PrismRA

Medical Disclaimer

This information is offered to educate the general public. The information posted on this website does not replace professional medical advice, but for general information purposes only. There is no Doctor – Patient relationship established. We strongly advise you to speak with your medical professional if you have questions concerning your symptoms, diagnosis, and treatment.

Journal Club

Proven Benefits of a Plant-Based Diet for Rheumatoid Arthritis Relief

March 19, 2024

Can a plant-based diet help relieve rheumatoid arthritis symptoms?

Rheumatoid arthritis (RA) is an autoimmune condition characterized by chronic inflammation of the joints, leading to progressive tissue damage, pain, stiffness, and decreased mobility. In the quest to find more holistic approaches to manage this debilitating condition, recent scientific research has turned attention to dietary interventions, particularly the role of plant-based diets.

A pivotal study, often referred to as “Plants for Joints” (PFJ), has shed new light on this area, providing noteworthy insights into how incorporating plants in the diet could potentially alleviate the symptoms of rheumatoid arthritis.

Understanding the Study Framework

In the meticulously structured ‘Plants for Joints’ (PFJ) study, participants who were randomized to the intervention group embarked on a carefully tailored, multidisciplinary program targeting their rheumatoid arthritis. The initiation of their journey involved individualized consultations with a dietitian and a physical therapist, designed to design the intervention to their specific needs. Over the course of the program, these individuals participated in 10 group sessions that lasted between 2 to 3 hours each, fostering a supportive community environment in which peer education and support were actively encouraged.

Out of the cohort, 17 individuals experienced the entirety of the program through in-person sessions, while another 23 navigated a hybrid model—owing to COVID-19 precautions—with a mix of 2 to 4 live and additional virtual sessions. At the heart of the program was a comprehensive educational component that covered theoretical and practical aspects of a whole-food, plant-based diet, consistent with the 2015 Guidelines on Healthy Nutrition from the Health Council of the Netherlands. Furthermore, participants were guided to establish achievable physical activity targets, aligning with the 2017 Dutch Physical Activity Guidelines, which advocate for 150 minutes of moderate-intensity activity weekly, supplemented by twice-weekly muscle and bone-strengthening exercises.

Addressing Lifestyle with Rheumatoid Arthritis

To address the components of lifestyle influencing rheumatoid arthritis, psychoeducation was provided to elucidate the impact of stress on health, coupled with stress management strategies. Sleep optimization was also a component of the intervention, recognizing its vital role in health and wellbeing. Participants had access to resources including general information, instructional videos, and exercises that could be performed at home. Nourishment for the program was not just theoretical—participants were equipped with a meticulously planned weekly menu, bolstered by daily supplements of the active form of vitamin B12 (1500 mg) and the active form of vitamin D (50 µg) to ensure intake of crucial nutrients commonly deficient in a plant-based diet, such as protein, omega-3 fatty acids, iron, zinc, iodine, and calcium.

In contrast, the control group received standard medical care without any alterations to their existing dietary or lifestyle regimen, thus establishing a baseline against which the intervention’s efficacy could be measured.

Scientific Outcomes of the Intervention

The findings from the PFJ study were both encouraging and scientifically significant. Participants who adhered to the plant-based diet showed a remarkable decrease in RA disease activity, as determined by both subjective measures (such as patient global assessment and tender joint count) and objective measures (including swollen joint count, body composition, and an assortment of metabolic markers).

These improvements suggest a noteworthy improvement of symptomatic expression of RA, potentially attributed to the anti-inflammatory and immunomodulatory effects of the diet.

Furthermore, the holistic nature of the intervention, incorporating physical activity and stress management, underscores the multifaceted approach required in managing rheumatoid arthritis effectively. This aligns with current understanding that RA management should extend beyond pharmacological treatments to include lifestyle modifications to maximize patient outcomes.

Critical Analysis of the Study’s Limitations

While the outcomes of the PFJ study are indeed promising, it is imperative to approach these findings with a critical lens, especially considering the study’s limitations. The sample size was relatively small, and the intervention period lasted only 16 weeks, raising questions about the long-term sustainability and effectiveness of such dietary changes in RA management. Additionally, because the study intentionally combined multiple lifestyle factors, discerning the individual contribution of the plant-based diet versus other interventions (physical activity, stress reduction) to the observed health benefits becomes challenging.

It is also noteworthy that the study reported improvements in both subjective and objective measures of disease activity. However, the degree to which extra attention provided to the intervention group (participant observation bias) influenced these outcomes cannot be entirely dismissed.

Moving Forward: Implications for Clinical Practice and Research

The PFJ study provides a compelling foundation for the potential role of plant-based diets in managing rheumatoid arthritis. Nonetheless, further research with larger randomized controlled trials is essential to fully understand the long-term effects and practicality of implementing such dietary changes. Investigations exploring the specific components of plant-based diets that are most beneficial for RA patients, as well as studies assessing the efficacy of these diets in different RA phenotypes, are needed.

Conclusion

In conclusion, the “Plants for Joints” study provides insightful evidence into the positive impact of plant-based diets on rheumatoid arthritis management. While promising, the complexities of RA and the limitations of the current study necessitate cautious interpretation and further investigation. For individuals living with rheumatoid arthritis, considering dietary changes as part of a comprehensive management strategy could offer additional pathways to alleviate symptoms and improve quality of life. Nonetheless, such decisions should always be made in consultation with healthcare professionals, ensuring a tailored approach that meets each individual’s unique health needs.

Medical Disclaimer

Diseases and Conditions Journal Club

Exploring New Ways to Keep ANCA Vasculitis in Check

February 12, 2024

ANCA Vasculitis is a rare but serious condition where the body’s immune system mistakenly attacks its own blood vessels, causing inflammation. This falls into a group of illnesses known as autoimmune diseases. Each year, about 3 out of every 100,000 people get diagnosed with it, mainly those who are between 50 and 70 years old. One of the biggest hurdles in treating ANCA Vasculitis is preventing it from coming back, which calls for some creative solutions to keep the disease in remission.

A groundbreaking study titled “Maintenance of Remission of ANCA Vasculitis by Rituximab Based on B Cell Repopulation Versus Serological Flare: A Randomised Trial” sheds light on a novel tactic for tackling this challenge. It zeroes in on the drug Rituximab, which helps calm the immune system’s overreaction that’s at the heart of this condition.

Why Focus on Rituximab for ANCA vasculitis?

Rituximab targets B cells, which play a big part in the body’s overactive immune response seen in ANCA Vasculitis. Doctors usually give this medication when they notice B cells coming back after treatment or when there’s a spike in ANCA levels, which can mean the disease is flaring up.

The Two Approaches Explained

The study looks at two ways of deciding when to give extra doses of Rituximab:

The first way is based on whether B cells are starting to show up again after being knocked down by treatment.
The second way relies on monitoring ANCA levels in the blood, even if the patient isn’t showing any symptoms, to catch any potential flare-ups.

What the Study Found

This research offers new insights by comparing these two strategies. It found that using Rituximab based on the return of B cells leads to fewer relapses than waiting for ANCA levels to rise, over an average follow-up of 4.1 years. This result supports the idea that tailoring treatment to each patient’s specific situation can really make a difference in managing complex autoimmune diseases like ANCA Vasculitis.

However, both methods have their challenges, such as predicting disease flares accurately and the feasibility of frequent testing. The study also closely monitored safety, noting similar side effects in both groups but a slightly higher risk of serious issues related to COVID-19 in those treated based on B cell repopulation.

Personalized Care for ANCA Vasculitis is Key

The findings highlight that there’s no one-size-fits-all answer to treating ANCA Vasculitis. Some patients might do better with one approach over the other, emphasizing the importance of customizing treatment plans.

Looking Ahead

This study is a significant step forward in improving how we maintain remission in ANCA Vasculitis. It encourages us to keep asking questions and searching for better ways to care for those affected by this disease.

Even though the medical terms might sound complex, they’re part of understanding how to best manage ANCA Vasculitis. As we work to unravel these complexities, it’s crucial to keep learning, adapting, and showing compassion for those living with this condition.

This research marks an important progress in our journey, and we’re committed to sharing the latest and most accurate information to help make informed health decisions. Our dedication to understanding and empathizing with your health challenges stands firm.

References

Zonozi R, Cortazar FB, Jeyabalan A, Sauvage G, Nithagon P, Huizenga NR, Rosenthal JM, Sipilief A, Cosgrove K, Laliberte KA, Rhee EP, Pendergraft WF 3rd, Niles JL. Maintenance of remission of ANCA vasculitis by rituximab based on B cell repopulation versus serological flare: a randomised trial. Ann Rheum Dis. 2023 Dec 11:ard-2023-224489. doi: 10.1136/ard-2023-224489. Epub ahead of print. PMID: 38123922.

Medical Disclaimer

The information in this video is not intended nor implied to be a substitute for professional medical advice, diagnosis or treatment. All content, including text, graphics, images, and information, contained in this article is for general information purposes only and does not replace a consultation with your own doctor/health professional

Diseases and Conditions Journal Club

Osteoarthritis and the Weather: What the Research Shows

January 9, 2024

Does the Weather Affect Your Joint Pain?

We’ve all felt the pain of osteoarthritis before – that aching knee pain that flares up right before a big storm. Or those creaky hips that seem to get worse when the humidity is high. It’s a common belief that changes in the weather can influence joint pain, especially for people with arthritis and other joint conditions. But is this just a myth or is there real science behind the connection?

Researchers conducted a study and found that certain weather conditions can worsen joint pain. The study provides interesting insights into this common belief. It shows that there are connections between specific weather conditions and increased pain levels. This could have implications for managing joint symptoms.

Study Overview

Osteoarthritis is a common joint disease that causes pain and stiffness, especially in the knees, hips, hands, and spine. Many people with osteoarthritis feel that their pain gets worse depending on the weather. Researchers looked at previous studies to see if certain weather conditions like cold temperatures, rain, and humidity are really linked to worse osteoarthritis pain. The analysis combined data from quality studies that looked at connections between weather and osteoarthritis symptoms. By putting together information from these studies, the analysis was able to provide stronger statistical evidence about possible links between weather and osteoarthritis pain. Overall, they found evidence that lower temperatures and higher humidity are connected to worse osteoarthritis pain. The connections were small but still important statistically.

Study Methods

The researchers ultimately identified 14 eligible studies involving a total of 2,194 osteoarthritis patients from 5 different countries. Most studies relied on patient self-reports of osteoarthritis pain severity, often using standardized scales. Local meteorological agencies provided the weather data.

By looking at the data from these 14 studies altogether, the researchers could see general trends and patterns in how the weather is linked to osteoarthritis pain. This type of method allows for stronger conclusions by addressing the issues of smaller individual studies.

Key Findings

The meta-analysis found that there was a significant association between worse osteoarthritis pain and lower temperatures. Across the studies analyzed, each 10°C decrease in temperature was associated with patients reporting a 1.3 unit increase in joint pain on a 0-10 scale.

The research showed that when the air pressure drops, people with arthritis tend to feel more pain. For example, when the air pressure dropped by 10 hectopascals, the pain levels increased by 0.6. It’s like how you might feel more achy when a storm is about to hit.

Therefore, the findings indicate that colder temperatures and drops in atmospheric pressure tend to coincide with worsening osteoarthritis symptoms. Patients with osteoarthritis may be able to use local weather forecasts to anticipate bad pain days and plan accordingly.

Possible Explanations

Physiologically, there are several reasons why changes in weather may exacerbate osteoarthritis pain.

Barometric pressure changes – Drops in barometric pressure are associated with storms and rain which have been shown to increase joint pain. Some hypothesize that lower atmospheric pressure allows tissues to expand, putting pressure on joints.
Temperature changes – Cold weather causes blood vessels to constrict, likely decreasing blood flow and nutrient supply to joints. This may limit the joint’s ability to heal microtraumas. Heat and humidity can cause swelling and inflammation in joints.
Humidity – Higher humidity prevents joints from releasing heat as effectively. This heat buildup can increase inflammation and swelling.
Solar and geomagnetic activity – Some research indicates solar flares and geomagnetic storms may impact pain perception thresholds and inflammation. The exact mechanisms are unknown.
Vitamin D levels – Less sun exposure in winter can lower vitamin D levels which play a role in pain, inflammation and bone health.

The body’s complex response to weather changes likely involves multiple biological mechanisms that can influence osteoarthritis pain and inflammation.

Study Limitations

This systematic review was based on observational studies, which have inherent limitations compared to experimental studies like randomized controlled trials. The authors note some key limitations of the observational studies included:

Confounding factors – There may have been confounding variables that influenced the association between weather and osteoarthritis pain that were not measured or accounted for. Things like mood, activity levels, and use of pain medications could all impact pain levels.
Reporting/recall bias – Most studies relied on self-reported pain scores, which can be influenced by recall bias. People may not accurately remember and report their daily pain levels over time.
Small sample sizes – Many of the individual studies had relatively small sample sizes, limiting their statistical power to detect associations. Larger studies are needed to confirm findings.
Variability in methods – There was heterogeneity in the study designs, pain measurement tools, statistical analyses, and weather data collection. Standardized methods could improve consistency.
Limited weather data – Localized weather data may not fully reflect individuals’ actual exposure to weather conditions. More precise measurement tools could improve accuracy.
Population specificity – Most studies focused on patients in a single geographic area. Findings may not be generalizable to osteoarthritis patients worldwide exposed to different climates and weather patterns.

Additional Research Needed

This systematic review and meta-analysis provides important insights into the relationship between weather conditions and osteoarthritis pain. However, researchers need to conduct more studies to fully understand this connection.

Some key questions that require further investigation include:

What specific weather conditions have the biggest impact? This review looked broadly at temperature, precipitation, and barometric pressure. More studies on the effects of particular weather elements (heat, cold, humidity, etc.) could uncover more nuanced relationships.
How do weather changes trigger osteoarthritis pain? The mechanisms and pathways are still unclear. Understanding the biological processes involved could reveal potential treatment targets.
Can weather forecasts be used to predict and manage osteoarthritis pain? If robust predictive relationships can be established, weather-based pain forecasting models could help patients and doctors better manage symptoms.
What interventions can help? Beyond predicting pain, research should explore what coping methods or treatments could help osteoarthritis patients during weather changes known to worsen symptoms.
How do effects differ across demographics? More studies are needed on how factors like age, gender, ethnicity, and osteoarthritis subtype influence weather-pain connections.
Can location-specific research provide more insights? Larger studies across diverse geographic regions may uncover location-specific relationships and climate patterns that impact osteoarthritis pain.

Further research to address these key questions can lead to a more meaningful understanding of weather-osteoarthritis links, enabling better prediction, management and treatment for osteoarthritis joint pain during problematic weather conditions.

Takeaways for People

Many patients with osteoarthritis experience increased joint pain and stiffness when the weather changes. While the exact mechanisms behind this phenomenon are still unclear, here are some tips that may help ease discomfort during weather fluctuations:

Stay active and keep moving. Low-impact exercises like walking, swimming, or biking can help keep joints mobile. Avoid inactivity which can make stiffness worse.
Dress appropriately. Layer clothing and wear warm covers over painful joints to avoid getting chilled. Consider wearing compression sleeves or gloves.
Use heated pads or cold packs. Apply whichever one gives you relief – heat opens up blood vessels, while cold reduces inflammation.
Consider over-the-counter pain medication. Acetaminophen, NSAIDs, or topical creams/gels can provide some symptom relief. Consult your doctor first before starting any medication or supplement.
Adjust your environment. Increase humidity with a humidifier. Move painful joints closer to heat vents or fans.
Stay hydrated and eat a healthy diet. Drink plenty of water and consume anti-inflammatory foods like fatty fish, fruits, vegetables, and nuts.
Practice stress management. Pain can worsen with anxiety and tension. Try relaxation techniques like meditation, yoga, or deep breathing.
Get a massage or gentle stretch. This may loosen up tense muscles and decrease joint pain.
Communicate with your doctor. Report worsening pain and discuss treatment adjustments or assistive devices.

While it can be frustrating dealing with arthritis pain fluctuations, being proactive with self-care and talking to your provider can help you better manage symptoms

References

Wang L, Xu Q, Chen Y, Zhu Z, Cao Y. Associations between weather conditions and osteoarthritis pain: a systematic review and meta-analysis. Ann Med. 2023 Dec;55(1):2196439. doi: 10.1080/07853890.2023.2196439. PMID: 37078741; PMCID: PMC10120534.

Medical Disclaimer

This information is offered to educate the general public. The information posted on this website does not replace professional medical advice, but for general information purposes only. There is no Doctor – Patient relationship established. We strongly advised you to speak with your medical professional if you have questions concerning your symptoms, diagnosis

Journal Club

Sjögren’s Relief in Sight? Exciting Trial Results for Ianalumab

January 2, 2024

Ianalumab a new medication currently in trials may finally bring some relief to people living with Sjogren’s syndrome. Sjögren’s syndrome is an autoimmune disease that affects the body’s moisture-producing glands, causing symptoms like dry eyes, dry mouth, fatigue, and joint pain. It can occur by itself as primary Sjögren’s syndrome, or alongside other autoimmune diseases like rheumatoid arthritis as secondary Sjögren’s.

While there are treatments to help manage symptoms, there are currently no approved therapies that target the underlying autoimmune disease process in Sjögren’s syndrome. This represents a major unmet need, as the chronic inflammation caused by Sjögren’s can lead to other serious complications over time if left unchecked. Patients are eager for new treatment options that could offer better disease control.

About the Study

This randomized, double-blind, placebo-controlled phase 2b study aimed to evaluate the efficacy and safety of the monoclonal antibody ianalumab in patients with primary Sjögren’s syndrome.

This trial enrolled patients from different continents and had 3 groups: different amounts of ianalumab compared to a fake treatment. The goal was to find the best dose of ianalumab for treatment and to see how well it worked and how safe it was compared to the fake treatment.

As a phase 2b study, this trial represents an intermediate stage of clinical research. Phase 2 studies gather preliminary data on effectiveness and look at common short-term side effects. If results are favorable, the treatment proceeds to larger and longer phase 3 trials which focus more on safety, efficacy, and optimal dosage.

Study Objective

The main goal of this study was to check if ianalumab, a type of medication, is safe and effective for people with Sjögren’s syndrome. This syndrome is an autoimmune illness that affects the salivary and lacrimal glands, causing dry mouth and dry eyes. Ianalumab targets B-cell activating factor (BAFF), a substance that affects the survival and development of B cells. By targeting BAFF, ianalumab aims to reduce the hyperactivity of B cells, which is linked to Sjögren’s syndrome. Essentially, ianalumab works by breaking B cells and blocking BAFF to stop the development of B cells. This study aimed to find out if treatment with ianalumab could safely improve symptoms and reduce disease activity in Sjögren’s patients compared to a placebo.

Study Participants

The research looked at adults with primary Sjögren’s syndrome, an autoimmune disease that causes long-term inflammation and harm to the glands that produce moisture, such as the salivary and tear glands.

Participants were required to meet the 2016 ACR-EULAR classification criteria for primary Sjögren’s syndrome. They also had to have an ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index) score of ≥6, indicating active disease.

Key eligibility criteria included:

Adults aged 18-75 years old
Confirmed diagnosis of primary Sjögren’s syndrome
Active disease with ESSDAI score ≥6
Presence of at least one domain with an ESSDAI score ≥3
Eligible participants were not allowed corticosteroids exceeding 10mg/day prednisone equivalent.

The study aimed to enroll patients representing the full spectrum of primary Sjögren’s syndrome. Overall, it included adults with active and untreated disease across multiple centers internationally.

Ianalumab Treatment Arms

The study compared 5 treatment arms:

Placebo – Patients received a placebo injection every 4 weeks
Ianalumab 5 mg – Patients received 5 mg of ianalumab subcutaneously every 4 weeks
Ianalumab 50mg – Patients received 50 mg of ianalumab subcutaneously every 4 weeks
Ianalumab 300 mg – Patients received 300 mg of ianalumab subcutaneously every 4 weeks

Outcome Measures

The main outcome measures for assessing efficacy were the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) at week 24, and patient-reported outcomes using EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) and Short Form 36 Health Survey (SF-36) scores at weeks 4 and 24.

The ESSDAI measures disease activity across 12 organ-specific domains including salivary gland, articular, cutaneous, peripheral nervous system, etc. Typically a high ESSDAI is anything above 13, medium is between 5 and 13, and low is less than 5.

ESSPRI is used to measure patient-reported symptoms of dryness, fatigue, and pain. The SF-36 assesses quality of life across 8 domains – physical functioning, bodily pain, vitality, social functioning, emotional role functioning, mental health, general health perceptions, and physical role functioning.

By evaluating a combination of physician-assessed and patient-reported outcomes, the study aimed to provide a comprehensive view of ianalumab’s efficacy in treating both the clinical and symptomatic manifestations of primary Sjögren’s syndrome. The results across these measures would determine whether ianalumab could significantly improve disease activity, symptoms, and quality of life compared to placebo.

Ianalumab Key Results

The key results of the study showed that treatment with ianalumab improved ESSDAI and ESSPRI compared to placebo.

Patients treated with ianalumab 300mg had statistically significant improvements in ESSDAI scores compared to placebo at week 24.
Stimulated salivary flow increased with time and was most beneficial with people receiving the 300 mg dose.
Unfortunately, tear flow did not improve.

So in summary, treatment with ianalumab showed promising efficacy in improving patient-reported symptoms and disease activity in primary Sjögren’s syndrome compared to placebo in this phase 2b study.

Safety

Ianalumab demonstrated a safety profile comparable to placebo in this Phase 2b study. The rates of adverse events were similar between the ianalumab and placebo groups. The majority of adverse events were mild or moderate in severity.

The most common adverse events reported in the ianalumab groups were upper respiratory infections and sinus infections as well as headache, and urinary tract infection. These events occurred at similar frequencies in the placebo group as well.

There wasn’t a clear link between the dose given and the negative effects after using ianalumab. It’s important to note that the serious negative effects and infections were similar in both the ianalumab and placebo groups.

No deaths occurred during this study. Overall, subcutaneous dosing of ianalumab showed no significant safety signals in patients with primary Sjögren’s syndrome.

Next Steps

The results from this study indicate that ianalumab treatment shows promising efficacy in patients with primary Sjögren’s syndrome. Specifically, the 300 mg ianalumab dose significantly reduced ESSDAI scores compared to placebo after 24 weeks of treatment. The ESSDAI is a key outcome measure to assess efficacy of treatments for Sjögren’s syndrome.

Overall, ianalumab demonstrated an acceptable safety profile. While infusion reactions occurred more frequently with ianalumab compared to placebo, they were mostly mild to moderate in severity.

In summary, this phase 2b study provides evidence that targeting the BAFF cytokine with ianalumab could be an effective approach for treating Sjögren’s syndrome. The verdict is still out regarding the effect on fatigue but these results represent an encouraging development for patients with Sjogren’s syndrome.

References

Bowman SJ, Fox R, Dörner T, Mariette X, Papas A, Grader-Beck T, Fisher BA, Barcelos F, De Vita S, Schulze-Koops H, Moots RJ, Junge G, Woznicki JN, Sopala MA, Luo WL, Hueber W. Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjögren’s syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial. Lancet. 2022 Jan 8;399(10320):161-171. doi: 10.1016/S0140-6736(21)02251-0. Epub 2021 Nov 30. PMID: 34861168.

Medical Disclaimer

This information is offered to educate the general public. The information posted on this website does not replace professional medical advice, but for general information purposes only. There is no Doctor – Patient relationship established. We strongly advised you to speak with your medical professional if you have questions concerning your symptoms, diagnosis and treatment.

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Journal Club Overcoming Inflammation

Does eating fish help treat rheumatoid arthritis?

March 27, 2018

Does eating fish help treat rheumatoid arthritis? This is the question we will try to answer in this edition of RheumDoctor Journal Club. Rheumatoid arthritis is a common autoimmune condition that affects about 1% of the population. This disease can cause joint pain, swelling, and stiffness, as well as inflammation throughout the body. Disease modifying antirheumatic agents (DMARDs) are the standard of care for the treatment of rheumatoid arthritis. These medications help slow and stop the progression of the disease. Some of these medications include methotrexate, hydroxychloroquine, sulfasalazine, as well as biologic medications such as etanercept, tofacitinib, tocilizumab, etc.

We know from research from the 80s, that omega-3 fatty acids also help to decrease rheumatoid arthritis inflammation. We learned from the studies that supplementation with 3 g of omega-3 fatty acids is effective in decreasing inflammation. However, the studies focused on supplementation, not the consumption of whole natural fish.[1] [2]

Relationship between fish consumption and disease activity in rheumatoid arthritis[3]

The objective of the study was to determine whether people who ate fish frequently tend to have lower rheumatoid arthritis disease activity. The researchers conducted a cross-sectional analysis from a large group of patients evaluating cardiovascular disease. Their outcome was the disease activity score known as the DAS28, as well as C-reactive protein (CRP). CRP measures inflammation throughout the body.

Patients completed a 120 item food questionnaire. Because we think long-chain fatty acids degrade when exposed to high heat, fried fish, non-fried shellfish, and fish in mixed dishes, the research did not count them. It could be boiled, steamed, baked, or eaten raw.

Results

176 people were included in the analysis. The majority of these people were middle-aged, college-educated white women, who are taking DMARDs and who were seropositive, and had rheumatoid arthritis for a long time.

19.9% of the people reported infrequent fish consumption (never to <1/month), 17.6% were frequent consumers (≥ 2 times/week). People who supplemented with fish oil were more likely to eat fish infrequently (20%). Interestingly, people who smoked cigarettes, were more likely to eat more fish

After adjusting for age and sex, people who consumed fish more than two times per week compared to those who ate fish infrequently, had lower disease activity scores and had lower CRP levels. Moreover, each additional serving of fish per week decreased both the disease activity score and the CRP. In a sensitivity analysis, the researchers found similar results after adjustments for biologic DMARDs and fish oil supplements. Further adjustment for smoking produced similar results.

What does this mean?

Simply put, eating fish two or more times per week may decrease rheumatoid arthritis activity as well as systemic inflammation. Although supplementing with fish oil also decreases inflammation in rheumatoid arthritis, there is something about eating fish as a whole natural food. One serving of fish almost certainly includes less than 5.5 g of omega-3 fatty acids given that an 8 ounce serving of fatty fish generally provides 2 to 4 g of omega-3 fatty acids. Whole natural fish has various macronutrients and micronutrients including omega-3 fatty acids that could be beneficial.

Then again, maybe people who regularly eat fish tend to have a healthier lifestyle. This could be the case, however, in this particular group, people who ate fish more regularly tended to smoke more. I think we can all agree that this isn’t the healthiest of lifestyle choices!

What we learned today

People who eat fish two more times per week compared to those who never eat fish or those who eat fish less than one time per month, tend to have lower rheumatoid arthritis, disease activity as well as systemic inflammation.

Eating non-fried fish on a regular basis is an important part of eating to beat rheumatoid arthritis.

Medical Disclaimer

This information is offered to educate the general public. The information posted on this website does not replace professional medical advice, but for general information purposes only. There is no Doctor – Patient relationship established. We strongly advised you to speak with your medical professional if you have questions concerning your symptoms, diagnosis and treatment.

References

[1] Kremer JM, Bigauoette J, Michalek AV, Timchalk MA, Linenger L, Rynes RI, Huyck C, Zieminski J, Bartholomew LE. effects of manipulation of dietary fatty acids on clinical manifestations of rheumatoid arthritis. Lancet. 1985 Jan 26;1(8422):184-7.

[2] Kremer JM, Lawrence DA, Petrillo GF, Litts LL, Mullaly PM, Rynes RI, Stocker RP, Parhami N, Greenstein NS, Fuchs BR, et al. Effects of high-dose fish oil on rheumatoid arthritis after stopping nonsteroidal anti-inflammatory drugs. Clinical and immune correlates. Arthritis Rheum. 1995 Aug;38(8):1107-14.

[3] Tedeschi SK, Bathon JM, Giles JT, Lin TC Yoshida K, Solomon DH. Relationship between fish consumption and disease activity in rheumatoid arthritis. Arthritis Care Res (Hoboken). 2018 Mar;70(3):327-332.

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