Guselkumab Improves Pain, Physical Function in Patients with Treatment-Resistant PsA

A real-world cohort of patients with treatment-resistant active psoriatic arthritis (PsA) receiving 6 months of guselkumab treatment achieved clinically meaningful improvements in pain (40.2%) and physical function (30%), according to a study published in ACR Open Rheumatology.¹

PsA has been shown to negatively impact health-related quality of life (HRQoL) due to impaired physical function, pain, fatigue, and psychological distress. Previous patient-reported data have revealed pain impacts HRQoL the most out of all PsA symptoms and often persists regardless of treatment.²

“Pain, physical function, fatigue, and patient global assessment of disease are Outcome Measures in Rheumatology (OMERACT) core domains recommended for all PsA randomized controlled trials and longitudinal observational studies,” wrote a team of investigators led by Philip J Mease, MD, clinical professor at the University of Washington School of Medicine and director of rheumatology research at the Swedish Medical Center in Seattle.

Investigators analyzed patients enrolled in the US-based CorEvitas PsA/Spondyloarthritis Registry who were treated with subcutaneous guselkumab 100 mg administered at weeks 0, 4, and every subsequent 8 weeks. Patient-reported outcomes, including assessments of pain, physical function, and overall disease activity, were assessed at a 6-month follow-up appointment.

For those who did not achieve response criteria at baseline, 6-month responses were collected regarding pain (Widespread Pain Index [WPI]) and physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]). Investigators also used the patient global assessment of arthritis and psoriasis (PtGA) to determine overall function and assessed fatigue with Question 1 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

Among the cohort of 90 On-Label Persisters, most had treatment resistant PsA. The mean time since symptom onset was 13.6 years and most patients had moderate disease activity, as indicated by a mean clinical Disease Activity Index for Psoriatic Arthritis score of 22.0.

Of these patients, 92.2% and 73.3% had previously received ≥ 1 and ≥ 2 biologic/targeted synthetic disease-modifying antirheumatic drugs (b/ts DMARDs), respectively. The mean baseline patient-reported pain was 57.0, the mean PtGA score was 50.3, and HAQ-DI score was .9.

For patients with patient-reported pain and PtGA scores of ≥ 15 at baseline, 40.2% (n = 33/82) and 46.8% (n = 36/77) were able to achieve ≥ 15-mm reductions at the 6-month mark, respectively.

Among patients with impaired physical function at baseline, as indicated by a HAQ-DI score > .5, 10.3% (n = 6/58) had normal physical function at the 6-month mark. For those with HAQ-DI scores of ≥ .35 at baseline, 30.4% (n = 21/69) were able to achieve clinically meaningful improvements at 6 months (P <.001).

The mean WPI score decreased by -1.1 from baseline in the On-Label Persisters cohort. Additionally, in the subgroup of patients with a WPI of ≥ 7 at baseline, the mean score decreased from 10.5 at baseline to 6.8 at month 6 (P <.001).

Investigators noted limitations including the small sample size coupled with possible time and selection biases. Additionally, results may not be generalizable to patients not living in the US or those who were treated with guselkumab but were not categorized as “On-Label Persisters.” Lastly, although findings are consistent with previous results from randomized controlled trials of up to 2 years, investigators encourage longer-term follow-up to confirm the persistence and durability in real-world settings.

“Therapies that provide improvement in these symptom domains, which are highly important to patients and often difficult to treat, may yield clinically important benefits in patients’ overall HRQoL,” investigators concluded.

References

1. ^{Mease PJ, Ogdie A, Tesser J, et al. Improvements in Patient-Reported Outcomes Through Six Months of Guselkumab Treatment in Patients With Active Psoriatic Arthritis: Real-World Data From the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. ACR Open Rheumatol. Published online February 28, 2024. doi:10.1002/acr2.11657}
2. ^{Lubrano E, Scriffignano S, Morelli R, et al. Assessment of widespread and extraarticular pain in psoriatic arthritis: a case-control study. J Rheumatol 2021; 48: 1405–9.}