Among biologic-naive patients with psoriatic arthritis (PsA), treatment with guselkumab is associated with enhanced general health-related quality of life (HRQOL) at 52 weeks, according to study results published in Advances in Therapy.
The phase 3, randomized, double-blind, placebo-controlled, 3-arm DISCOVER 2 study (ClinicalTrials.gov Identifier: NCT03158285) was conducted among adult patients with active PsA.
In the current study, the researchers sought to evaluate the effects of guselkumab on HRQOL through 52 weeks using the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) Index and the EuroQoL visual analog scale (EQ-VAS).
The EQ-5D-5L Index questionnaire is a patient-reported evaluation of health status across 5 dimensions (ie, mobility, self-care, ability to perform usual activities, pain/discomfort, and anxiety/depression), ranging from no problems through slight, moderate, severe, and extreme problems. In the EQ-5D-5L questionnaire, all individual scores are converted into a single summary index score that is graded on a scale of 0 (representing “death”) to 1 (representing “perfect health”). The EQ-5D-5L questionnaire also includes the EQ-VAS, in which individuals rate their daily health status as “worse imaginable” (0) to “best imaginable” (100).
In the current study, the EQ-5D-5L Index and EQ-VAS were administered at weeks 0, 16, 24, and 52.
Patients with PsA were randomly assigned 1:1:1 to receive treatment with subcutaneous guselkumab 100 mg every 4 weeks, guselkumab 100 mg at weeks 0 and 4 then every 8 weeks thereafter, or placebo (crossover to guselkumab 100 mg Q4W at week 24).
The percentage of participants who achieved minimally important differences (MIDs) were evaluated through week 52.
Overall, 739 individuals with PsA were included in the study, with 738 with available baseline EQ-5D-5L Index and EQ-VAS scores. Overall, 47.5% of the patients were women and 98.0% were White. The mean participant age was 45.7 years.
A total of 245, 248, and 245 patients with PsA received guselkumab every 4 weeks, guselkumab every 8 weeks, and placebo, respectively.
At baseline, patients had considerably impaired HRQOL, with a mean EQ-5D-5L Index of 0.6, which is below the US population norm of 0.9, and a mean EQ-VAS score of 44.6, which is below the US population norm of 79.3.
Results of the study showed that at week 24, least squares mean changes from baseline in treatment and placebo groups were 0.12, 0.12, and 0.05, respectively, for the EQ-5D-5L Index. Scores for the EQ-VAS were 18.2, 18.4, and 6.8, respectively.
At week 52, improvement continued in the guselkumab groups and increased in the placebo crossover group.
A total of 56.0% of participants achieved EQ-5D-5L Index in each guselkumab group at week 24, as well as by 66.2% in the Q4W arm, 68.5% in the Q8W arm, and 66.1% in the placebo crossover arm at week 52.
High C-reactive protein level, Psoriasis Area and Severity Index score, pain, and fatigue all were associated with worse EQ-5D-5L Index and EQ-VAS scores, according to pooled data through week 24. In addition, higher tender joint count was associated with a worse EQ-5D-5L Index, and higher swollen joint count was associated with a worse EQ-VAS score.
Limitations of the study were noted. Because data for the analysis were derived from patients fulfilling the inclusion criteria who were enrolled in the phase 3 DISCOVER-2 study, the results may not be generalizable to all patients with PsA. Further, since the statistic mapping system used to translate global EQ-5D-5L responses to singular 0 to 1 index scores was based on the US EuroQoL value set, an alternate country value set may have resulted in outcomes that varied slightly.
The researchers concluded, “The treatment of multiple PsA domains with guselkumab may lead not only to improvement in clinical signs and symptoms but also to enhanced patients HR[QOL] outcomes.”
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Curtis JR, McInnes IB, Rahman P, et al. The effect of guselkumab on general health state in biologic-naïve patients with active psoriatic arthritis through week 52 of the phase 3, randomized, placebo-controlled DISCOVER-2 trial. Adv Ther. 2022;39(10):4632-4644. doi:10.1007/s12325-022-02269-0