Infliximab Biosimilar Cross Reacts to Infliximab Antibodies

Estándar

The Rheumatologist

August 11, 2016 • By

Cross Reactions

A recent study published online in March in the Annals of the Rheumatic Diseases investigated if the infliximab biosimilar (CT-P13, infliximab-dyyb), which is marketed in Europe as Inflectra and Remsima, can be safely and effectively substituted for infliximab (Remicade).1 Infliximab and its biosimilar are manufactured via the same process. Researchers set out to determine whether those patients with antibodies to infliximab would mount a similar response to the infliximab biosimilar (CT-P13). Two-hundred and fifty patients with rheumatoid arthritis (RA) andspondyloarthritis undergoing infliximab treatment who had never been exposed to CT-P13 were evaluated.

All patients treated with infliximab who had antibodies to infliximab cross reacted with CT-P13, either Inflectra or Remsima. The authors note that the epitopes raising the immune response to infliximab demonstrate the same degree of reactivity to the infliximab biosimilar. However, due to different glycosylation patterns or impurities, CT-P13 may possess its own unique epitopes.

keep reading

Why Rheumatologist–Pulmonologist Collaboration Is Essential

Estándar

June 15, 2015 • By

Although close collaboration with a variety of specialists outside of rheumatology is important, you could make the case for rheumatologists and pulmonologists having to work together even more closely. If lung symptoms are severe and not under control,

However, the question sometimes is when to refer—even when there are not any evident lung symptoms and the patient’s rheumatic disease is well controlled with therapy.

Rheumatologists and pulmonologists have a great deal of clinical crossover for conditions like interstitial lung disease, pulmonary arterial hypertension in scleroderma and vasculitides (see sidebar, below). keep reading

HIV Infection: What Rheumatologists Need to Know

Estándar

June 15, 2015 • By Leonard H. Calabrese, DO, & Elizabeth Kirchner, MSN, CNP

It has been nearly 35 years since the original descriptions of what now is recognized as AIDS (the acquired immune deficiency syndrome), an advanced form of infection secondary to the human immunodeficiency virus (HIV). The epidemic of HIV infection remains the singular most dramatic epidemic of our generation and will likely remain with us for generations to come.

The disease itself (i.e., HIV infection) has been transformed from a highly fatal illness with a progressive course and no known therapy to a complex but manageable disease for those with access to antiviral therapy. Socially, the epidemic of HIV infection has changed from one of high visibility attended by fear and stigmatization to one that now has lost much of its exclusivity, affecting all segments of the population to some degree, albeit disproportionately.

keep reading

Rheumatism and diet.

Estándar

A very frequent question from patients who have a rheumatic disease is if there exists some diet specially indicated to improve, or that may deteriorate his/her disease. If you have the curiosity to googling “rheumatism and diet”, you’ll be surprised at the enormous quantity of information on multiple websites. Most diets are useless or invented. None

Mediterranean Diet

Mediterranean Diet

has shown a specific benefit to cure or improve rheumatism. I leave Gout apart because this disease deserves a separate few lines

But using common sense, any person can improve his/her general heath status. Mediterranean diet is not specific for rheumatism; this is part of the culture of Mediterranean countries. Mediterranean diet has demonstrated that is possible to live better and longer:

  • If you are obese or overweight, lose weight. Combine with exercise
  • Eat five times daily
  • Use Olive Oil
  • Take fruit, vegetables and legumes in abundance
  • Eat pasta, but be careful with dressing¡
  • Take fish rich in omega 3 (fish such as salmon, sardines, etc.) but keep in mind they are quite caloric
  • Take some walnuts, nuts. A few there are caloric
  • Eat white meat., chicken, white veal, etc.
  • Red meat is only recommended one time every 12-15 days
  • Avoid fried food as much as possible (crisps, chips, etc.)
  • You may take several eggs a week (5-6)
  • Take care with greasy sausages and cheeses.
  • Drink one or two glasses of wine a day. But it’s good wine. You know this quote life is too short to drink bad wine
  • But mostly especially use your common sense

keep reading

Biologics for Rheumatic Diseases

Estándar

First, we will mention Rheumatoid Arthritis (RA) because the first biologic launched to the market was directed to treat this disease. Multiple factors cause RA, but once the diagnosis is established is crucial to start treating these patients as soon as possible, to induce the remission of the disease. Until the past century in the therapeutic armamentarium we had few drugs to treat RA. All, were chemical compounds like NSAIDS, corticosteroids, gold salts (now withdrawn from the market because of their side effects), hydroxychloroquine, sulfasalazine, leflunomide and Methotrexate (MTX), which, has become the gold standard to treat the disease. However, not all patients (30-50%) respond to these meds and the disease progresses gradually towards a significant disability. Therefore at the end of the twentieth century, the possibility of producing other, more complex drugs was devised. These new drugs are call biologics since they are not chemical formulations,

They are complex proteins, mainly monoclonal antibodies, that block other proteins (called cytokines) involved in inflammation in RA. One of the most prominent pro-inflammatory cytokines is TNF. Therefore, the first biologics were designed to block TNF.

Distintos Biológicos para la AR

Distintos Biológicos para la AR

See below the anti-TNF that are in the pharmaceutical market (in brackets the commercial name)

  • Infliximab, IV administration (Remicade®). Now we have two infliximab-biosimilar products in Europe, and in some other countries called Remsima® and Inflectra® (in another section I will explain what means a biosimilar drug)
  • Etanercept weekly subcutaneous administration (Enbrel®)
  • Adalimumab, biweekly subcutaneous administration (Humira®)
  • Certolizumab, biweekly subcutaneous administration (Cimzia®)
  • Golimumab monthly subcutaneous administration (Simponi®)

Biologics non anti-TNF

Apart TNF, interleukin 6 (IL-6) is another cytokine involved in inflammation. Tocilizumab (RoActemra®) is the first anti-IL-6 approved to treat RA. Tocilizumab is administered IV monthly but recently a subcutaneous formulation has been launched.

Interestingly, a biologic that years ago was used to treat non-Hodgkin lymphoma -Rituximab- was shown to be useful in RA. Rituximab is administered IV at least once every six months. (Mabthera®). This biologic acts against B lymphocytes, which are responsible for producing antibodies.

Finally, another relevant biologic is Abatacept (Orencia®). Abatacept interferes with the contact between the interaction of two types of lymphocytes (T and B) that are essential for the harmful effects of the disease occur. Abatacept has an IV presentation but recently a subcutaneous presentation is in the market.

Ankylosing Spondylitis (AS)

For AS, only anti-TNF have been shown to be effective and have been licensed to treat the disease. Other promising drugs are under development, but it may take a few years to have other biologics to treat this disease

Psoriatic Arthritis PsA

Until recently only anti-TNF had been licensed to treat this disease. Recently, a new non anti-TNF biologic Ustekinumab (Stelara®) has been approved to treat PsA. Ustekinumab was launched first for cutaneous psoriasis, but it took a while to demonstrate that it was also efficacious in PsA.

Promising New Imaging Modality for Enthesitis Whole body MRI can detect ethesitis in PsA and axSpA patients.

Estándar

Primary Source
Annals of the Rheumatic Diseases
Source Reference: Poggenborg RP, et al “Enthesitis in patients with psoriatic arthritis, axial spondyloarthritis and healthy subjects assessed by ‘head-to-toe’ whole-body MRI and clinical examination” Ann Rheum Dis 2015; DOI: 10.1136/annrheumdis-2013-204239.

Whole body magnetic resonance imaging (WBMRI), which allows assessment of all peripheral and axial joints and entheses in one examination, is a promising new imaging approach to detect enthesitis in patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), a new prospective, cross-sectional pilot study has found.

The study showed that “it is possible to detect enthesitis by “head-to-toe” WBMRI with moderate percentage agreement between MRI and clinical findings at the entheseal level”, according to Rene Penduro Poggenborg, Copenhagen Centre for Arthritis Research and Copenhagen Center for Rheumatology and Spine Diseases, Denmark, and colleagues.
ADVERTISEMENT

The study, published in the Annals of the Rheumatic Diseases, included 18 patients with PsA and 18 with axSpA, all with moderate to high disease activity. It also included 12 healthy controls (HS) without pain from peripheral joints or spine, family history of PsA, spondyloarthritis or rheumatoid arthritis, or personal history of psoriasis, anterior uveitis, inflammatory bowel disease, or heel pain.
Clinical enthesitis was defined as tenderness when the enthesis was palpitated with a pressure of the thumb until the tip of the nail bed blanched. Experienced clinicians examined study subjects at 18 peripheral and axial entheses at 35 different anatomical sites.
With MRI evaluations, enthesitis was defined as the presence of bone marrow edema, soft tissue edema, change in tendon thickness, erosions or enthesophytes in adjacent bones, and additional findings such as fluid around tendons or adjacent to bursa, alone or in combination.

keep reading

Vitamin D Tracks Systemic Lupus Erythematosus Activity Study first in Southern Hemisphere to examine role of vitamin D in SLE disease activity

Estándar

In systemic lupus erythematosus (SLE) low vitamin D status is associated with higher disease activity and erythrocyte sedimentation rate (ESR), while over time, an increase in serum vitamin D levels correlates with reduced SLE activity.

These findings were reported in an Australian study — the first to examine this correlation in the Southern Hemisphere — published online in Lupus Science and Medicineon April 8, 2015.

Following the discovery that vitamin D receptors are expressed by immune cells, vitamin D’s potential role in regulating the immune response has attracted attention, noted researchers led by Kristy Yap, MBBS, of the Centre for Inflammatory Diseases at Monash University, Melbourne.

Deficiency of this vitamin has been associated with several autoimmune diseases including multiple sclerosis, rheumatoid arthritis, type 1 diabetes mellitus, and SLE. A recent study, for example, showed that vitamin D3 inhibits dendritic cell maturation and expression of IFN-induced genes in SLE patients.

During 2007-2013, the Melbourne researchers studied 119 consecutive SLE patients (mean age 42.2) from the Monash Medical Centre Lupus Clinic. Of these, 77.5% were female, 56.3% were white, 37.8% were Asian, and 5.9% were of other or unknown race. With a mean disease duration of 8.7 years and a mean SLEDAI of 5.6, all patients were receiving antimalarial treatment, with 58.8% on glucocorticoids, 33.6% on immunosuppressants, and 14.2% on prednisolone. More than four in 10 (44.5%) were taking vitamin D supplements.

Baseline serum 25-hydroxyvitamin D concentration and disease activity via the SLE Disease Activity Index 2000 SLEDAI-2K) were documented, and adjustments made for the use of glucocorticoids, immunosuppressants, and vitamin D supplements.

keep reading