Brodalumab – 5 Years of Data on Efficacy, Safety, and Quality of Life Improvement in Plaque Psoriasis

Psoriasis Brings Many Limitations

Although psoriasis primarily manifests in the form of dermatological lesions, the disease has much broader implications for patients. It negatively impacts health-related quality of life and emotional well-being, increases the risk of comorbidities and mortality, raises the likelihood of suicidal thoughts, creates social stigma, and limits patients in employment and productivity.

In pivotal studies involving patients with moderate to severe plaque psoriasis, brodalumab improved the condition more effectively in terms of skin lesions compared to ustekinumab. Additionally, brodalumab was shown to improve health-related quality of life and alleviate depression and anxiety. The aim of the presented study was to assess the long-term efficacy and safety profile of brodalumab in patients with moderate to severe plaque psoriasis.

Study Methodology

Patients who completed an initial 12-week double-blind, placebo-controlled phase II clinical trial without serious adverse treatment-related events were enrolled in an open-long extension study. In the follow-up long-term study, they received 210 mg of brodalumab subcutaneously every 2 weeks (Q2W). Efficacy was assessed using the static physician's global assessment (sPGA) score and the Psoriasis Area and Severity Index (PASI). The overall report also included quality of life evaluated by the Dermatology Life Quality Index (DLQI) and the safety of brodalumab administration.

Course and Results

A total of 181 patients enrolled in the study, with a median brodalumab administration duration of 264 weeks. As this was a long-term extension of a phase II dose-ranging study, a protocol change allowed patients with a body weight of ≤ 100 kg (65.2% of participants) to reduce the administered dose to 140 mg Q2W. However, since dose reduction was associated with decreased efficacy in 30 patients, another protocol change allowed these patients to increase the dose back to 210 mg Q2W. This step was followed by a return to pre-dose reduction efficacy levels.

Treatment with brodalumab led to a rapid improvement in sPGA, PASI, and DLQI parameters, which persisted up to week 264. Achieving PASI 90 to < 100 or PASI 100 in weeks 12, 240, and 264 was associated with a higher likelihood of DLQI 0 or 1 compared to patients who achieved PASI 75 to < 90.

The most frequently observed adverse events were nasopharyngitis (29% of patients), respiratory infections (24%), and arthralgia (20%). Over 5 years, there was 1 case of suicidal ideation, no suicides, and no new safety profile insights were observed.

Conclusion

During 5 years of therapy, brodalumab sustainably improved skin lesions and patients' quality of life and showed an acceptable safety profile comparable to short-term treatment.

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Source: Lebwohl M. G., Blauvelt A., Menter A. et al. Efficacy, safety, and patient-reported outcomes in patients with moderate-to-severe plaque psoriasis treated with brodalumab for 5 years in a long-term, open-label, phase II study. Am J Clin Dermatol 2019; 20 (6): 863–871, doi: 10.1007/s40257-019-00466-2.