Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy. CONCLUSION: This pilot study indicates that the combination with NB-UVB improves the efficacy of efalizumab monotherapy in the treatment of moderate to severe psoriasis. To evaluate the efficacy and safety of long-term, continuous efalizumab therapy in patients with psoriasis. Patients were categorized as discontinued only if they withdrew from the study and did not enter follow-up or discontinued from the study segment and entered the follow-up.
Recent research has evaluated the efficacy and safety of a new anti-TNF agent, adalimumab. Thus, adalimumab seems to be a promising therapeutic approach for patients who suffer from moderate to severe plaque psoriasis. Traditional treatments for moderate to severe psoriatic disease include phototherapy, systemic retinoids, methotrexate, and cyclosporine. Biologic patent information for Raptiva, drug master files, orphan drug status, clinical trials, and more. Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy Status: Completed Condition: Psoriasis A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp Status: Completed Condition: Psoriasis Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells Status: Withdrawn Condition: Autoimmune Diseases Efalizumab to Treat Uveitis Status: Completed Condition: Uveitis; Macular Edema TRUST Study: Raptiva in Hand & Foot Psoriasis Status: Terminated Condition: Chronic Plaque Psoriasis. If there is active disease, TB treatment must be begun before initiation of the biologic. The Canadian Coordinating Office for Health Technology Assessment (Shukla, 2003) concluded that in clinical trials of patients with moderate to severe psoriasis, alefacept showed a modest but statistically significant increase in the number of responders compared to placebo. Both studies evaluated the efficacy and safety of Humira in clearing skin in moderate to severe adult plaque psoriasis patients versus placebo.
Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy. Some guidelines provide specific criteria to help evaluate the severity of a patient’s psoriasis, but all recognize the importance of assessing both the physical and psychosocial burden when considering the best treatment approach 7 10. Finally, it remains to be determined if biologic therapies can be used in combination without an increased safety risk. Gisondi P, Girolomoni G. Combination of efalizumab and acitretin in chronic plaque psoriasis. This analysis evaluated approaches for managing inflammatory recurrence after discontinuation of efalizumab. Several large clinical studies have established the safety and efficacy of efalizumab during extended treatment of patients with moderate-to-severe chronic plaque psoriasis 8 10. Patients were enrolled in the study if: (1) they had worsening of psoriasis within 2 months of discontinuation from efalizumab treatment in other studies, which in the opinion of the investigator had not worsened sufficiently to constitute a rebound but that required re-initiation of treatment or, (2) had previously discontinued an efalizumab study due to an inflammatory disease flare. Combined therapy: systemic corticosteroids plus methotrexate, utilising both of the above regimens in combination.
Treating Psoriasis With Adalimumab
However, long-term treatment in patients with moderate to severe psoriasis is limited by the potential for toxic effects on organs, such as renal, hepatic or bone marrow, in addition to teratogenicity and malignancies that are associated with the traditional systemic therapies. Four biologic therapies (adalimumab, efalizumab, etanercept and infliximab) which had been thoroughly revised, are now licensed for the treatment of moderate-to-severe psoriasis. Randomized double-blind, placebo controlled studies have demonstrated short-term efficacy and safety of all therapies for psoriasis. However, combinations of traditional systemic and biologic therapies may be required. Over the past decade, technological advancements have resulted in a substantial increase in the number of new molecules under investigation for the treatment of psoriasis. Thereafter, the endpoint was further validated using a combination of other statistical methodologies, external references, and prospectively in an independent on-going live clinical trial setting. Therapeutic management of psoriasis usually requires a patient-tailored approach in which combination and sequential therapies are often considered over time in order to augment response, to optimize the safety profile, and/or to meet specific clinical needs. Since the time of the first observations documenting the clinical activity of CsA in psoriasis, more than 30 years ago 4, a considerable amount of clinical data has been accumulated in favour of the efficacy and safety of the drug in many immunomediated skin disorders and especially psoriasis and atopic dermatitis. Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. The safety and efficacy of Simponi in patients aged less than 18 have not yet been established. After proper training in subcutaneous injection technique, patients may self-inject with Simponi if their physician determines that this is appropriate, with medical follow-up as necessary. There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation. Information on the treatment options available for Rheumatoid Arthritis from the Johns Hopkins Arthritis Center. Patients starting methotrexate should be carefully evaluated for renal insufficiency, acute or chronic liver disease, significant alcohol intake or alcohol abuse, leukopenia (low white blood cell counts), thrombocytopenia (low platelet counts), or untreated folate deficiency. Methotrexate can be combined safely with nearly every other FDA-approved DMARDs for RA, including sulfasalazine, hydroxychloroquine, TNF inhibitors, abatacept, rituximab, tocilizumab, anakinra, and leflunomide. Leflunomide has also been studied in psoriatic arthritis with some efficacy demonstrated. Combination treatment with methotrexate (an antifolate drug which suppresses the immune system) has been shown to reduce the formation of these antibodies in patients with rheumatoid arthritis 22 and combination therapy with other immunosuppressants has been shown to reduce the likelihood of these antibodies being formed in Crohn’s disease.
The type and clinical manifestations of psoriasis in a patient depend on a combination of genetic influences, environmental factors (i. Although psoriasis patients are typically thought to be at decreased risk of cutaneous infection, those with erythrodermic psoriasis may be at risk for Staphylococcus aureus septicemia as a result of their compromised skin barrier therefore it is important for emergent evaluation by a dermatologist. Thousands of combinations are possible, and patients should discuss with their doctors the best treatment for their individual needs. A topical form of vitamin D3, calcipotriene (Dovonex) is proving to be both safe and effective. Combining vitamin D ointments with systemic medicines, notably methotrexate, acitretin, or cyclosporine, increases its effectiveness. Alone or in combination with methotrexate for the treatment of adult patients with active psoriatic arthritis. The efficacy and safety of SIMPONI have been evaluated in one of the most comprehensive clinical development programs for an anti-TNF-alpha therapy, which included simultaneous studies in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Tell your doctor if you are prone to or have a history of infections or have diabetes. If you take SIMPONI or other TNF blockers, your risk for developing lymphoma or other cancers may increase.