Real-World Effectiveness of 9–12 Months of Guselkumab Therapy among Patients with Moderate-to-Severe Plaque Psoriasis in the CorEvitas Psoriasis Registry

Guselkumab is a fully-human immunoglobulin G1λ antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23), inhibiting its interaction with the IL-23 receptor [1]. In the pivotal phase III VOYAGE 1 (NCT02207231) and VOYAGE 2 (NCT02207244) clinical trials, the therapy was shown to significantly improve several disease activity endpoints and patient-reported outcome measures (PROMs) compared with placebo and adalimumab among patients with moderate-to-severe plaque psoriasis [2, 3]. On the basis of these studies, the Food and Drug Administration (FDA) and Health Canada approved guselkumab in 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy [1, 4]. Guidelines from the American Academy of Dermatology and the National Psoriasis Foundation (NPF) recommend guselkumab monotherapy for this indication [5].

Although randomized-controlled trials remain the gold standard for evaluation of the safety and efficacy of new therapies, study protocols may not include the entire spectrum of patients seen in clinical practice [6]. The current study therefore sought to assess the real-world effectiveness of 9–12 months of guselkumab therapy among patients with moderate-to-severe psoriasis (defined as IGA [Investigator’s Global Assessment] ≥ 3 and body surface area [BSA] ≥ 10%) enrolled in the CorEvitas Psoriasis Registry. This work builds on a recently conducted analysis of patients with a broader range of psoriasis severities (IGA score ≥ 2, indicating mild or greater disease) followed in the registry, which showed that up to 1 year of persistent guselkumab therapy led to statistically significant improvements from baseline across several disease activity outcomes and PROMs [7]. It was hypothesized that similar to the previous analysis, treatment with guselkumab would improve these outcomes among patients with moderate-to-severe psoriasis.

Between 18 July 2017, and 10 March 2020, a total of 1301 patients were identified who had initiated guselkumab at or after the time of enrollment in the CorEvitas Psoriasis Registry (Fig. 1). Of these patients, 825 had at least one follow-up visit and 547 had persistent use of guselkumab for at least 9 months; 240 of these patients had initiated guselkumab at a registry visit and had a follow-up visit that occurred between 9 and 12 months after the index date. Among these patients, 235 had plaque psoriasis, and 113 had an IGA score ≥ 3 and BSA ≥ 10% at the index visit. These 113 patients represented the population for analysis.

This study prospectively analyzed real-world data from 113 patients with moderate-to-severe psoriasis who had received persistent treatment with guselkumab for 9–12 months in the USA and Canada and were enrolled in the CorEvitas Psoriasis Registry. The findings show that, similar to our analysis of patients with baseline IGA severities of mild, moderate, or severe (IGA ≥ 2) [7], guselkumab-treated patients experienced significant improvements from baseline in psoriasis activity, the ability to work, overall HRQoL, symptom burden, and daily functioning. With the exception of IGA 0/1 and WPAI work hours affected, the magnitude of improvement in all outcomes was higher in the current study than in our prior analysis. This finding is not unexpected, given differences in baseline characteristics (e.g., biologic exposure) between the study cohorts.

Real-world evaluations of drug therapies are important to inform clinical practice, given that differences commonly exist between the characteristics of patients receiving therapy in everyday care versus those enrolled in randomized clinical trials. Several other real-world studies of guselkumab have been conducted that also included varying definitions of moderate-to-severe psoriasis. Most of these evaluations were retrospective in design, included smaller patient populations, had shorter follow-up durations, and/or evaluated fewer outcomes than the current study [7, 18‐32]. Furthermore, although guselkumab has been commercially available in the USA and Canada since 2017 [1, 4], only two previous real-world studies included patients living in these countries [7, 22]. Regardless, similar to the findings of the current analysis, these investigations showed that guselkumab therapy was associated with improvements in disease severity outcomes (e.g., PASI, BSA) and a limited number of PROMs (e.g., DLQI, PGA). The magnitude of these improvements varied across the other real-world studies and the current analysis, likely resulting from differences in baseline patient characteristics. As highlighted above, evidence from other investigations suggests that an increased response to guselkumab therapy may be achieved among patients who are biologic naïve, as well as those without comorbidities and potentially those with lower BMIs [18, 20, 23‐25]. As such, additional analysis of the CorEvitas population is warranted to understand outcomes among these patient subgroups and others, such as those with concomitant PsA.

In this real-world study of patients with moderate-to-severe plaque psoriasis in the CorEvitas Psoriasis Registry, 9–12 months of persistent treatment with guselkumab was associated with statistically significant improvements in all evaluated disease activity outcomes and PROMs. These benefits extend beyond the reductions in disease activity that have been reported in previous real-world studies of guselkumab, showing improvement of overall HRQoL, symptoms, the ability to work, and daily functioning, and provide additional support for the label indication for guselkumab. Evaluation of longer-term treatment with guselkumab, as well as its use in other subpopulations that may experience variations in response, is warranted to fully understand the effectiveness of therapy.