Registry data reveal long-term control and drug survival rival pivotal trials despite heavier disease burden.
Adalimumab maintains strong, durable control of chronic plaque psoriasis in Australian clinical practice, new real-world registry data shows.
The monoclonal antibody matched, and in some cases exceeded, long-term trial outcomes despite being used in a more treatment-experienced and higher-severity population, the researchers found.
Results have been published in the Australasian Journal of Dermatology.
Adalimumab is a fully human monoclonal antibody that targets tumour necrosis factor-alpha (TNF-α), a central proinflammatory cytokine implicated in the pathogenesis of psoriasis.
In Australia, access to biologic therapies such as adalimumab is subsidised under the Pharmaceutical Benefits Scheme. Access is limited to patients with severe psoriasis meeting defined eligibility criteria, notably a Psoriasis Area and Severity Index (PASI) > 15 and failure to at least two non-biologic systemic therapies.
Adalimumab was listed on the PBS in Australia for the treatment of chronic plaque psoriasis in June 2009, based on results from the Phase III REVEAL and CHAMPION trials. In the REVEAL trial, adalimumab achieved significantly greater PASI75 response rates at week 16 compared to placebo. Similarly, the CHAMPION trial demonstrated the superiority of adalimumab over both placebo and methotrexate.
The latest AJD study assessed adalimumab efficacy and drug survival in routine clinical practice, comparing outcomes with the Phase 3 REVEAL trial and its open-label extension.
It drew on data from the Australasian Psoriasis Registry for adults meeting PBS criteria to be prescribed adalimumab for chronic plaque psoriasis.
It included 306 adults treated between June 2006 and March 2022, with investigators reporting sustained PASI responses and consistent drug survival under routine PBS prescribing conditions.
Nearly 60% of patients had prior biologic exposure, compared with 12.8% in the pivotal REVEAL trial. Baseline disease severity was higher, with a mean PASI of 24.1 versus 18.3 in the REVEAL open-label extension.
At three months, 63.5% of patients achieved PASI75 and 33.6% achieved PASI90, closely aligning with week 16 results from REVEAL (68% and 37%, respectively). Beyond 12 months, PASI90 responses in the registry cohort remained stable through three years and from 18 months onwards exceeded rates observed in the REVEAL extension.
Even when treatment discontinuations were included in the analysis, long-term PASI90 responses compared favourably with trial data.
The cohort reflected Australian PBS eligibility criteria, which require a PASI >15 and prior failure of at least two systemic therapies, resulting in a population with more refractory disease than those typically enrolled in phase 3 trials.
Despite this, response trajectories paralleled or surpassed those achieved under controlled trial conditions.
Higher body mass index was independently associated with reduced likelihood of achieving PASI90.
Patients with BMI 30–34.9 or ≥35 had significantly lower response rates after adjustment for baseline PASI and smoking status.
Smoking, alcohol consumption, psoriatic arthritis, comorbidity burden and prior biologic exposure were not significantly associated with PASI90 attainment.
Drug survival analysis showed a median treatment duration of 27.9 months. Retention rates were 97.7% at three months, 78.6% at nine months, 63.7% at 15 months and 51.0% at 27 months.
Achieving clinical response strongly predicted persistence, the researchers noted. Patients who reached PASI75 had a 76% lower risk of discontinuation and a median drug survival of 52.3 months, compared with 10.1 months among non-responders.
Patients who achieved PASI ≤3 demonstrated even greater durability, with median drug survival exceeding eight years.
Related
Male sex and older age were associated with longer drug survival, while liver disease significantly increased discontinuation risk. In multivariable analysis, male sex and achieving PASI <2 remained independently associated with improved persistence.
Biologic-naïve status did not significantly influence drug survival, contrasting with registry findings reported for some other biologic classes.
The authors acknowledged limitations inherent in observational registry data, including non-aligned visit timing with trial schedules and incomplete capture of discontinuation reasons.
“This real-world study of Australian patients with chronic plaque psoriasis supports that adalimumab is an effective and well-tolerated treatment, demonstrating sustained drug survival and robust PASI responses comparable to clinical trial data,” they concluded.
“Male sex and older age predicted longer drug survival, while liver disease increased discontinuation risk, with no impact from prior use of biologics.
“These findings reinforce adalimumab’s broad applicability across diverse patient populations in everyday clinical practice.”
