Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2000-02-08
2002-04-16
Low, Christopher S. F. (Department: 1653)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C436S509000, C514S012200, C514S825000
Reexamination Certificate
active
06372715
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is concerned with the use of erythropoietin and iron preparations for the production of pharmaceutical combination preparations. These combination preparations comprise individual administration forms of an erythropoietin preparation and a physiologically compatible iron preparation corresponding to an equivalent amount of 1-40 mg of iron ions for the treatment of rheumatic diseases.
Pharmaceutical combination preparations containing erythropoietin and iron preparations are known from PCT Patent Application WO 97/09996. The preparations are utilized especially for the optimization of erythropoiesis in the treatment of illnesses in which a stimulation of erythrocyte formation is striven for.
The use of erythropoietin for the treatment of chronic inflammations, especially of rheumatoid arthritis, is known from WO 96114081.
The therapeutic treatment of patients suffering from rheumatic diseases has hitherto still not been possible using a satisfactory treatment regimen. In this respect, there exists a need for improved treatment methods, such as, for example, in the treatment of rheumatoid arthritis, lupus erythematosus, Bechterew's disease, etc.
Rheumatic diseases of the locomotor system and inflammatory joint diseases are worldwide one of the main causes of chronic pains and severe bodily damage. All elements of the musculoskeletal system are in a dynamic equilibrium and their form, structure and functional state change constantly depending on loading and mechanical requirements. This system is susceptible to trauma and responsive to localized and systemic inflammatory disorders. Acute inflammatory conditions or tissue injuries often result in chronic conditions, possibly because of the constant movements and mechanical loadings.
Joint diseases belong to diseases of the locomotor system and are sub-divided into those which concern the periarticular tissue and those which are true joint diseases (e.g. arthrosis). Symptoms and diagnoses can often lead back to a systemic, generalized disease or also to illnesses which primarily emanate from another system or organ.
Immune-mediated inflammation plays an important role in the pathological course of rheumatic disorders. In many cases immune-mediated inflammation is the basis of numerous systemic connective tissue diseases. Infectious processes are also of significance, primarily in diseases such as rheumatic fever, Lyme borreliosis or reactive arthritis. The etiology of rheumatic diseases may be multi-factorial, with genetic reasons and environmental effects also having an important influence.
Pain is a major symptom of most rheumatic diseases, especially of joint diseases. Hitherto, the causes of joint pain have been largely unclear. A therapeutic control of joint pain is possible at present only in an inadequate manner. Also, the decisive factors of a loss of function have previously not been completely clear. Many of the most important joint diseases show in their incidence remarkable differences between sexes; thus, SLE occurs primarily in women, while ankylosing spondylitis occurs more frequently and in more severe form in men. The reasons for this are likewise unclear.
The incidence, prominence and consequences of diseases of the locomotor system depend on age and sex. Some diseases occur only in childhood (juvenile chronic arthritis); others, such as SLE or ankylosing spondylitis, begin mainly in young adults, polymyalgia rheumatica and granulomatous arteritis on the other hand almost never occur before the age of 55. cP, SLE, gout and other serious inflammatory rheumatic diseases show a different initial prominence with increased age. Most of these diseases of the locomotor system cause chronic pain.
No medicament having a satisfactory activity is available for healing these chronic rheumatic diseases. The therapeutic principles used in the treatment are frequently based on and often depend on factors such as the age and overall situation of the patient and the extent of inflammatory activity and of the consequences (pain intensity, extent of impediment). The treatment plan used in practice for patients with severe diseases of the locomotor system is composed of different measures and is in this respect often dependent on the treating physician. A uniform and generally accepted treatment method has hitherto not been established.
SUMMARY OF THE INVENTION
It has surprisingly now been found that a positive influence on the overall disease picture in patients with rheumatic diseases and an improvement in the general health and the quality of life of these patients can be achieved with the aid of an optimal amount of EPO and iron in the form of a corresponding combination preparation. Further, an optimal activity of EPO and respectively, of the iron preparation employed is achieved. In particular, the costs of the treatment with EPO can be clearly reduced in that, for example, lower dosages of the active substance can be administered. The combination preparations in accordance with the invention are especially suitable for the treatment of inflammatory joint diseases. Further, in many patients a clear alleviation of pain can be achieved.
REFERENCES:
patent: 0 025 721 (1981-03-01), None
patent: 2 171 304 (1986-08-01), None
patent: WO 96/14081 (1996-05-01), None
patent: WO 97/09996 (1997-03-01), None
Pincus et al. Multicenter Study of Recombinant Human Erythropoietin in Correction of Anemia in Rheumatoid Arthritis. (1990) Am. J. Med. vol. 89, pp. 161-168.*
Nordstrom et al., Rheumatology International, 1997, 17 (2), pp. 67-73.
Hochli et al., European J. Haematology, 1993, 51(1), pp. 54-55.
Kaltwasser Joachim Peter
Lehmann Paul
Johnston George W.
Low Christopher S. F.
Roche Diagnostics GmbH
Schnizer Holly
Tramaloni Dennis P.
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