Arthritis Drugs & New Medications-2001 Meeting (cont.)

Dr. Shiel's Perspective: This does not surprise me, since it is the same situation for adults with rheumatoid arthritis who are being treated in my practice.

Remicade was reported as a successful treatment for a child with dermatomyositis, a severe disease with inflamed muscles.

Dr. Shiel's Perspective: This was only a single case report, but it was an impressive one. The patient, an 18 year old boy, had had dermatomyositis since age 11 years. He was becoming more and more seriously ill despite powerful treatments with cyclophosphamide (Cytoxan), methotrexate, intravenous immunoglobulin, plasmapheresis, and steroids. He was unable to move out of bed. After starting Remicade intravenous infusions, he gradually became stronger, his muscle enzyme tests normalized after being elevated in the thousands, and he eventually walked again. Remicade's action in blocking TNF-alpha is probably the reason he improved. Dermatomyositis has been associated with elevated levels of TNF-alpha in the blood.

Remicade was reported by a number of groups of researchers as a beneficial treatment of a serious form of eye inflammation, uveitis.

Dr. Shiel's Perspective: This interesting use of Remicade will likely slip into the arsenal of doctors treating uveitis, which is a horrible, painful cause of blindness. I have recently had the occasion to witness this result first hand in my practice. I had a man come to me with a history of uveitis due to Behcet's syndrome. This patient nearly went blind while undergoing a litany of traditional therapies for his eye until a university professor started him on Remicade infusions. He was able to discontinue all other medications and he remarkably stabilized.

ENBREL (etanercept)

Enbrel is an injectable anti-tumor necrosis factor for treating rheumatoid arthritis. Tumor necrosis factor (TNF) is a protein that the body produces during the inflammatory response, which is the body's reaction to injury. TNF promotes the inflammation and its associated fever and signs (pain, tenderness, and swelling) in several inflammatory conditions, including rheumatoid arthritis. Enbrel is a synthetic (man-made) protein that binds to TNF. Enbrel thereby acts like a sponge to remove most of the TNF molecules from the joints and blood. This prevents TNF from promoting inflammation and the fever, pain, tenderness, and swelling of joints in patients with rheumatoid arthritis (and apparently other forms of inflammatory arthritis, such as psoriatic arthritis, ankylosing spondylitis, and juvenile arthritis-see below).

Enbrel plus methotrexate was reported at this meeting to be more effective than Enbrel alone.

Dr. Shiel's Perspective: This may be true, to a degree, for both Enbrel and Remicade, but I use them individually or with methotrexate or other drugs on a case by case basis.

The long-term safety of Enbrel in more than 2,600 patients over 5 years was reported. There was no cumulative toxicity with extended use and the clinical response was sustained for up to 5 years of the study.

Dr. Shiel's Perspective: These long-term statistics are very helpful for doctors who are assessing the value of this relatively new treatment for rheumatoid arthritis.

Enbrel was found to be safe when used in combination with Kineret (see below).

Dr. Shiel's Perspective: A combination therapy using more than one antirheumatic drug is commonly necessary in the treatment of certain patients with rheumatoid arthritis. This combination awaits further studies of Kineret before it is used commercially.

Enbrel increases general functioning of patients with rheumatoid arthritis.

Dr. Shiel's Perspective: This is important for doctors in office practice because we want to help our patients get to their optimal functional status.

Enbrel was found to be effective in patients with juvenile rheumatoid arthritis.

Dr. Shiel's Perspective: Enbrel is already approved for the use in treating juvenile rheumatoid arthritis that has not responded to other disease-modifying rheumatic drugs.

Enbrel was reported as effective for treating psoriatic arthritis and ankylosing spondylitis. For those with psoriasis, Enbrel not only helped the arthritis, but also helped to clear the psoriasis, often dramatically. In those treated with Enbrel, there were no serious, unforeseen side effects.

Dr. Shiel's Perspective: This is a welcome addition to treatment options, which have been sorely lacking for these diseases.

Enbrel-treated patients were able to mount a normal immune response to Pneumococcal vaccine.

Dr. Shiel's Perspective: This is significant in that it demonstrates that while TNF-blocking could theoretically increase the infection rate by impeding the immune system, at least the antibody-producing branch of the immune system is functional.

Two papers documented the effectiveness and safety of Enbrel in the treatment of ankylosing spondylitis in children (juvenile ankylosing spondylitis).

Dr. Shiel's Perspective: These are important papers that will open up options of treatment for this rare disease of children and even children under the age of 4 years, according to one of the studies.

Enbrel was documented to be effective and safe in treating juvenile rheumatoid arthritis in children under the age of 4 years.



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