Discussion in 'Fibromyalgia Main Forum' started by IgotYou, Aug 9, 2003.
My mom has suggested I look into it. Anyone know whether it's worth looking into?
Where did she hear of it???
Is it being done for us in the US??
Never heard of it myself.
Sounds like some type of procedure with the blood. I will look it up & post if it sounds earth shaking.
Source: Blue Cross Blue Shield, note the date tho, not the latest info out there I am sure, just for your info......
Extracorporeal Photopheresis for the Treatment of Autoimmune Disease
Volume 16, No. 10
Extracorporeal photopheresis is a procedure in which a sizeable percentage (usually from 10% to 15%) of a patient’s white blood cells (the “buffy coat” fraction) are removed from the body by leukapheresis and suspended in a sample of the patient’s plasma. Either by ingestion prior to leukapheresis or by direct addition to the leukapheresis product, these cells are exposed to a relatively inert drug, 8-methoxypsoralen (8-MOP), that is activated by ultraviolet light in a specific, relatively narrow range of wavelengths (UVA light). After the cell suspension is exposed to UVA in the presence of 8-MOP as a thin layer in a specially designed device, the cells are washed free of drug and re-infused into the patient. Several lines of evidence suggest that therapeutic benefits from this treatment are mediated by the patient’s immune response to cells that were chemically modified when photoactivated 8-MOP reacted with macromolecules inside the cells or on their surfaces.
Photopheresis using 8-MOP and UVA was initially developed as a treatment for cutaneous T-cell lymphoma (CTCL), particularly the Sézary syndrome, an erythrodermic form of this uncommon type of non-Hodgkin’s lymphoma. Refractory advanced CTCL is the only indication for extracorporeal photopheresis that has been reviewed and approved by the U. S. Food and Drug Administration (FDA). Recent investigations have explored the possibility that extracorporeal photopheresis may be useful to treat patients with various other T-cell mediated diseases. The objectives of this Assessment are to review the available evidence on outcomes of extracorporeal photopheresis in patients with autoimmune diseases, including:
progressive systemic sclerosis (scleroderma);
pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, or other autoimmune bullous (blistering) diseases;
systemic lupus erythematosus;
psoriatic arthritis or psoriasis vulgaris;
type I diabetes; or
other autoimmune diseases such as atopic dermatitis, juvenile dermatomyositis, or scleromyxedema.
Based on the available evidence, the Blue Cross and Blue Shield Medical Advisory Panel made the following judgments about whether extracorporeal photopheresis meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria as treatment for autoimmune diseases.
1. The technology must have final approval from the appropriate governmental regulatory bodies.
The UVAR photopheresis system (Therakos, Inc; a subsidiary of Johnson and Johnson) received premarket application (PMA) approval from the U.S. Food and Drug Administration (FDA) on April 8, 1987. It is indicated for use to irradiate extracorporeally circulating leukocyte-enriched blood with ultraviolet-A (UVA) light in the presence of the photoactivatable drug methoxsalen (8-methoxypsoralen or 8-MOP) for palliative treatment of skin manifestations from cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other therapy. Presently,
the UVAR system is the only photopheresis device with PMA approval from the FDA. No device has FDA approval for treatment of autoimmune diseases. Therefore, use of the UVAR photopheresis system for autoimmune diseases is an off-label use of an FDA-approved device.
Methoxsalen capsules (ICN Pharmaceuticals) are approved by the FDA for oral administration in combination with UVA irradiation or photopheresis. FDA-approved indications for methoxsalen capsules in combination with UVA irradiation include: symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy; and repigmentation of idiopathic vitiligo. FDA-approved indications for methoxsalen capsules in combination with photopheresis are limited to those indications approved for the UVAR photopheresis system (i.e., CTCL). Therefore, use of methoxsalen capsules
for photopheresis in the treatment of an autoimmune disease would be considered an off-label use of a FDA-approved drug.
A new drug application for a sterile solution of methoxsalen (UVADEX; Therakos, Inc.) received FDA approval on February 25, 1999. It is indicated for use in conjunction with the UVAR photopheresis system in the palliative treatment of skin manifestations from cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other forms of treatment. Therefore, use of methoxsalen sterile solution for an autoimmune disease would be considered an off-label use of a FDA-approved drug.
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The study selection criteria for this Assessment were studies that reported measurable outcomes of extracorporeal photopheresis on symptoms or disease activity. Studies meeting selection criteria were identified for the following autoimmune diseases.
Progressive Systemic Sclerosis (Scleroderma). The available evidence on outcomes of extracorporeal photopheresis included one single-blind randomized control trial (n=79) and 3 small uncontrolled series (combined n=24). The trial randomized 39 patients to photopheresis and 40 to drug therapy with D-penicillamine. Six and 10 months after randomization, respectively, outcomes were reported for 31 and 29 evaluable photopheresis patients and 25 and 18 penicillamine patients.
At 6 months, skin thickness measurements improved by greater than 15% in significantly more of the evaluable patients treated with photopheresis than in those treated with penicillamine (68% versus 32%, p=0.02). However, neither the difference in percentage improved by greater than 15% at 10 months (69% versus 50%) nor the differences in percentage worsened by greater than 15% at either 6 or 10 months achieved statistical significance. Measurements of the oral aperture and hand closure also showed greater improvement in the arm given photopheresis than in the arm given penicillamine. In contrast, there were no significant differences between arms
in pulmonary function tests, serology for anti-nuclear antibodies, or skin biopsy results. Adverse effects of the oral 8-methoxypsoralen and photopheresis procedure included clotting problems, nausea, vasovagal reaction, and hypotension, but did not result in any withdrawals. In contrast, 6 patients withdrew from the penicillamine arm because they were unable to tolerate the drug.
A number of methodologic concerns make it difficult to interpret results from this trial. These include: the short treatment duration and follow-up period; the excessive number of unevaluable patients in each arm; a change in the primary outcome from greater than 25% to greater than 15% improvement in skin scores either mid-study or after its completion; insufficient information on the distribution of prior treatments, disease progression, visceral involvement or quality of life; inadequate washout of prior penicillamine therapy; and no significant effects on the primary outcome at ten months or on pulmonary function, serology, or skin biopsy at any time. Results reported from the small uncontrolled series (combined n=24) conflict with each other and do not resolve the difficulties with interpreting the controlled trial. Taken together, the available evidence is insufficient to permit conclusions on the effects of extracorporeal photopheresis as therapy for progressive systemic sclerosis (scleroderma).
Pemphigus, Pemphigoid or other Bullous Diseases. The available evidence on outcomes of extracorporeal photopheresis was limited to 2 uncontrolled case series with a total of 11 patients. Because of the small number of patients, absence of controls, inadequate definition of responses, and lack of information on the durability of responses, this evidence is insufficient to permit conclusions on the outcomes of extracorporeal photopheresis.
Systemic Lupus Erythematosus. The available evidence on outcomes of extracorporeal photopheresis was limited to one uncontrolled case series with only 10 patients. Because of the small number of patients, absence of controls, and lack of information on the durability of responses, this evidence is insufficient to permit conclusions on the outcomes of extracorporeal photopheresis.
Multiple Sclerosis. The available evidence on outcomes of extracorporeal photopheresis was limited to one randomized, double-blind, placebo-controlled trial with a total of 14 patients. There were no differences reported between the patients treated with photopheresis (n=8) and the controls given sham photopheresis (n=6) for any measured outcomes. However, this study is insufficient to permit conclusions on the effects of extracorporeal photopheresis as therapy for multiple sclerosis because of the small sample size and short duration of treatment.
Psoriatic Arthritis or Psoriasis Vulgaris. The available evidence on outcomes of extracorporeal photopheresis was limited to 2 small uncontrolled series of patients with psoriatic arthritis (combined n=13) and a third small series of patients with psoriasis vulgaris (n=4). Because of the small number of patients, absence of controls, conflicting results between the available studies, and short duration of follow-up, this evidence is insufficient to permit conclusions on the outcomes of extracorporeal photopheresis.
Rheumatoid Arthritis. The available evidence on outcomes of extracorporeal photopheresis was limited to 2 small uncontrolled series (combined n=14). Because of the small number of patients, absence of controls, and short duration of treatment and follow-up, this evidence is insufficient to permit conclusions on the outcomes of extracorporeal photopheresis.
Type 1 Diabetes. The available evidence on outcomes of extracorporeal photopheresis was limited to one randomized, double-blind, placebo controlled trial. This study randomized 25 patients to 12 weeks of therapy with oral 8-MOP and photopheresis, and 25 patients to an oral placebo and sham photopheresis. Evaluable patients in the photopheresis group (n=19) required less insulin than those in the control group (n=21) over 3 years of follow-up. There also was evidence for increased production of endogenous insulin among patients in the active treatment group. However, no patients in either group produced sufficient endogenous insulin to obviate the need for insulin administration. Evidence from this study is insufficient to permit conclusions on the effects of extracorporeal photopheresis for type 1 diabetes.
Other Autoimmune Diseases. Single case reports that did not meet study selection criteria were the only publications identified on the use of extracorporeal photopheresis to treat other autoimmune diseases, including severe atopic dermatitis (n=3), scleromyxedema (n=1), and juvenile dermatomyositis (n=1). This evidence is insufficient to permit conclusions on the outcomes of extracorporeal photopheresis for other autoimmune diseases.
3. The technology must improve the net health outcome; and
4. The technology must be as beneficial as any established alternatives.
The evidence is insufficient to determine whether extracorporeal photopheresis improves the net health outcome or is as beneficial as any established alternatives for the treatment of any of the autoimmune diseases.
5. The improvement must be attainable outside the investigational settings.
Whether extracorporeal photopheresis improves the net health outcome and is as beneficial as any established alternative has not yet been demonstrated in the investigational setting for any of the autoimmune diseases.
Based on the above, extracorporeal photopheresis does not meet the TEC criteria as therapy for progressive systemic sclerosis (scleroderma), pemphigus or other autoimmune bullous diseases, systemic lupus erythematosus, multiple sclerosis, psoriasis, rheumatoid or psoriatic arthritis, type 1 diabetes, or other autoimmune diseases.
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