More psoriasis patients achieve efficacy when they receive continuous treatment with Humira (adalimumab) compared to patients who interrupt their therapy, according to data presented at the European Academy of Dermatology and Venereology (EADV) Congress in Paris.
The findings were from a sub-analysis of Abbott's (NYSE: ABT) pivotal, 52-week study, REVEAL (The Randomized Controlled EValuation of Adalimumab Every Other Week in Moderate to Severe Psoriasis Trial) and the period of open-label treatment that followed.
The sub-group analysis was designed to determine whether interrupting Humira treatment would affect efficacy in psoriasis patients who had already achieved good response to Humira . After 33 weeks, patients who had achieved adequate response to Humira (as measured by PASI 75, or greater than 75 per cent clearance) were randomized into two groups. One group continued to receive Humira and the other was given placebo. Beginning at week 52, all patients received Humira during the open-label extension period.
Patients who had maintained adequate response after Humira was discontinued were more likely to achieve a PASI 75 response when they were restarted on treatment. Among those who discontinued and then re-started Humira , 84 per cent of the 161 patients who had maintained adequate response achieved PASI 75 after 24 weeks of re-treatment, compared to 55 per cent of the 66 patients who had lost adequate response after stopping treatment. A loss of adequate response was defined as less than PASI 50 response relative to baseline and at least a 6-point increase in PASI score relative to week 33.
"The goal of treatment for dermatologists is to maintain disease remission, and these results are relevant to use of Humira in psoriasis patents," said Kim Papp, M.D., of Probity Medical Research in Waterloo, Ontario Canada.
A separate analysis of REVEAL evaluated whether specific patient characteristics would affect the efficacy of Humira therapy. This second sub-group analysis found that Humira effectively treats adults with psoriasis regardless of a patient's age, disease duration, whether the patient has a diagnosis of psoriatic arthritis (PsA), or if he or she has a recent history of systemic therapy, including biologic treatments. At 16 weeks, 71 per cent of patients treated with HUMIRA achieved a PASI 75 response, compared with 6.5 per cent of patients treated with placebo, with similar results seen among the patient subgroups.
The REVEAL study was a 52-week, double blind, randomized, placebo-controlled phase III trial to evaluate the efficacy and safety of Humira in 1,212 patients with moderate to severe chronic psoriasis in the United States and Canada.
Humira is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis, ankylosing spondylitis (AS), Crohn's disease and juvenile idiopathic arthritis (JIA) in the United States and Europe. Humira resembles antibodies normally found in the body. It works by blocking tumour necrosis factor alpha (TNF-?), a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases. To date, Humira has been approved in 76 countries and more than 270,000 people worldwide are currently being treated with Humira . Clinical trials are also under way evaluating the potential of Humira in ulcerative colitis.
In Europe, Humira , in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including MTX has been inadequate, and for the treatment of severe, active and progressive RA in adults not previously treated with MTX. Humira can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. HUMIRA has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with MTX.
Also in Europe, Humira is indicated for the treatment of active and progressive PsA in adults when the response to previous DMARD therapy has been inadequate and for the treatment of severe, active AS in adults who have had an inadequate response to conventional therapy. HUMIRA has Humira wn to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.
Humira is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. For induction treatment, Humira should be given in combination with cortiocosteroids. Humira can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate.
Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA.
Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in adolescents aged 13 to 17 years who have had an inadequate response to one or more DMARDs. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.