MedWire News: Patients with chronic plaque psoriasis can be treated effectively with adalimumab even if treatment with other anti-tumor necrosis factor (TNF) agents has failed, shows a subanalysis of the BELIEVE study.
Trials evaluating whether switching anti-TNF therapy in psoriasis patients who have previously failed, lost response, or been intolerant to a prior anti-TNF drug are lacking, says the research team.
The scientific basis for therapy failure remains unclear, remark Jean-Paul Ortonne (University of Nice, France) and colleagues, who add: "Whatever the reason… the results of BELIEVE refute the concept that patients who have a suboptimal response to one anti-TNF will necessarily have a suboptimal response to all anti-TNF agents."
The team compared the efficacy and safety of adalimumab in 730 psoriasis patients taking part in the BELIEVE study that enrolled patients with moderate to severe forms of the condition, and prior failure or contraindication to at least two systemic therapies.
Patients were randomly assigned to receive calcipotriol hydrate 52.2 µg/g plus betamethasone dipropionate 0.64 mg/g topical ointment (n=366) or a matching drug-free vehicle (n=364) daily for 4 weeks, in addition to adalimumab 80 mg subcutaneous at week 0, then 40 mg every other week from 1-15.
Ortonne and team assessed treatment efficacy at weeks 2, 4, 8, 12, and 16 by comparing the percentage of patients in each treatment group who achieved at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) score (PASI-75 response).
In all, 38.6% of the cohort had received previous anti-TNF therapies.
At week 2 of follow-up, those with and without a previous history of anti-TNF therapy had similar PASI-75 response rates, at 10.3% in each group. In contrast, by week 16, 61.7% of patients with prior exposure and 71.7% of those with no prior exposure had achieved a PASI-75 response.
These results did not change by type or number of previous anti-TNF therapies used.
Furthermore, efficacy analysis did not reveal any significant differences between treatment groups. Notably, the difference in PASI-75 response rate between patients who did and who did not receive previous anti-TNF therapy was small among those treated with adalimumab plus vehicle, say Ortonne et al.
The rate of serious adverse events was low, at 4.2% overall, and was similar among anti-TNF exposed and anti-TNF naive patients (3.9% and 4.5%) indicating good tolerance of adalimumab, conclude the researchers in the Journal of the European Academy of Dermatology and Venereology.
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