Improvement in PROs after 3-year treatment with ustekinumab or TNFi: Results from the real-world PsABio study

Psoriatic arthritis (PsA) affects ~30% of patients with psoriasis.¹ PsA can cause pain, fatigue, and swollen and tender joints, which can impact quality of life.¹ To provide a comprehensive understanding of treatment effectiveness, it is important to use patient reported outcomes (PROs) as a measurement of physical, psychological, and social functioning, alongside physician assessments in long-term clinical trials of PsA. Here, we summarize key findings from the multinational, prospective, real-world PsABio study (NCT02627768) which evaluated PROs after 3 years of treatment with ustekinumab or a tumor necrosis factor inhibitor (TNFi).

Study design

The final analysis of PsABio included 895 adult patients, with 439 randomized to ustekinumab and 456 randomized to TNFi. Of these, 219 receiving ustekinumab and 218 receiving TNFi remained on their original treatments for 3 years; the remainder switched or stopped treatment before this time. The following PROs were evaluated in patients who remained on treatment for 3 years:

• EuroQol-5 dimensions questionnaire (EQ‑5D)‑3L health state: EQ-5D and EQ visual analog scale (EQ VAS)
• 12-item PsA Impact of Disease questionnaire (PsAID-12)
• Work Productivity and Activity Impairment for PsA questionnaire (WPAI)
• Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA)

Results

Baseline patient characteristics for patients who remained on the same treatment for 3 years are shown in Table 1.

Table 1. Key baseline patient characteristics*

bDMARD, biologic disease-modifying anti-rheumatic drug; BMI, body mass index; cDAPSA, Clinical Disease Activity Index for Psoriatic Arthritis; TNFi, tumor necrosis factor inhibitor. *Adapted from Gossec, et al.1
Characteristic, % (unless otherwise stated)	Ustekinumab (n = 219)	TNFi (n = 218)
Mean age, years	51.5	46.7
Mean BMI, mg/m2	28.9	27.1
Sex
Male	48.4	56.0
Female	51.6	44.0
Mean time since initial diagnosis, years	7.7	6.4
Line of bDMARD
First-line	49.8	59.2
Second-line	32.4	31.7
Third-line	17.8	9.2
Mean cDAPSA score, n	30.3	30.3

Patient-reported outcomes

Mean change from baseline to year 3 in EQ-5D score and overall PsAID-12 score are shown in Figure 1. EQ-5D and PSAID-12 scores improved across the 3 years for both treatments.

EQ-5D, EuroQol-5 dimensions questionnaire; PsAID-12, 12-item PsA Impact of Disease questionnaire; TNFi, tumor necrosis factor inhibitor.
*Adapted from Gossec, et al.¹

The percentage of patients employed at baseline and year 3 was similar in both treatment groups (54.5% and 55.9% for the ustekinumab group and 61.5% and 64.1% in the TNFi group, respectively). Patients treated with a TNFi had greater changes in WPAI outcomes compared with patients treated with ustekinumab; however, they also started from a lower baseline for each outcome. Mean changes in WPAI outcomes from baseline to year 3 are shown in Figure 2.

TNFi, tumor necrosis factor inhibitor.
*Adapted from Gossec, et al.¹

Link between PROs and efficacy endpoints

At 6 months and 3 years, patients who achieved cDAPSA low disease activity/remission had higher (better) EQ-5D scores compared with patients who did not achieve this endpoint. Similarly, patients who achieved cDAPSA low disease activity/remission had lower (better) PsAID-12 scores at Month 6 and Year 3 compared with those that did not achieve this endpoint. Work impairment scores, as measured by WPAI outcomes, were lower (better) at 6 months in patients achieving cDAPSA low disease activity/remission, minimal disease activity, and very low disease activity vs those not achieving these endpoints; similar scores were observed at 3 years.

Conclusion 

Over 3 years of the PsABio real-world study, patients treated with both ustekinumab and TNFis demonstrated an improvement in PROs. Over the 3 years, work productivity increased steadily, with EQ-5D and PsAID-12 scores also improving for both groups. TNFi treated patients achieved larger improvements in PROs versus those treated with ustekinumab; however, this could have been influenced by differences in baseline measurements and factors influencing treatment decisions.

Work activity impairment, EQ-5D, and PsAID-12 scores were better in patients who achieved cDAPSA low disease activity/remission versus those who did not. Better scores were also seen in EQ-5D and PsAID-12 with cDAPSA remission, suggesting that an efficacious treatment may result in improved patient quality of life. However, further clinical trials evaluating this link are needed before conclusions can be made.