Ustekinumab improves arthritis-related and skin-related quality of life in patients with active psoriatic arthritis: Patient reported outcomes from randomized and double blinded phase III psummit I trial

OBJECTIVES:

Examine impact of ustekinumab treatment on general &diseasespecific patient reported outcomes (PROs) of patients with active PsA using PSUMMIT1 data.

METHODS:

Adult PsA patients (n=615) with active disease despite DMARD&/or NSAID therapy were randomized to ustekinumab 45mg, 90mg, or PBO at wks0, 4, &q12wks, thereafter. Patients treated with prior anti- TNF agents were excluded. At wk16, patients with <5% improvement in SJC/TJC entered blinded EE (PBO→ustekinumab 45mg; ustekinumab 45mg→90mg; 90mg→90mg). PROs were measured with HAQ, DLQI, SF-36, &VAS for impact of PsA on work productivity (0-10), patient assessment of pain (0-10)& disease activity (0-10). ANOVA on van der Waerden normal scores was used for continuous variables & chi-square or the Cochran-Mantel-Haenszel (CMH) test for binary variables between groups.

RESULTS:

Baseline PRO measures indicated the study population had severe physical disability& impaired HRQoL, with mean HAQ score of 1.25 &mean DLQI score of ≥10. At wk24, greater improvements in: HAQ (0.31&0.4 vs. 0.1, P<0.001), DLQI (6.6&7.5 vs. 1.4, P<0.001), SF-36 PCS (4.9 &6.2 vs. 1.4, P<0.001)& MCS (3.4&4.8 vs. 1.5, p<0.01 90 mg only) were observed in ustekinumab 45mg &90mg groups vs PBO, respectively. Proportions of patients who achieved clinical meaningful improvements in HAQ ≥0.3 (47.8% &47.5% vs. 28.2%, P<0.001), DLQI ≥5 (58.6% &63.1% vs. 32.9%, P<0.001), &SF-36 PCS ≥5(46.5% &53.3% vs. 26.0%, P<0.001) &MCS ≥5(37.0% &47.7% vs. 33.7%, p<0.01 90mg only) were greater in ustekinumab 45mg &90mg group vs PBO, respectively. Ustekinumab 45mg&90mg -treated patients achieved greater improvements in patient assessment of pain (25.9% &29.6% vs. 4.5%, P<0.001), patient assessment of disease activity (25.4% &27.6% vs. 7.6%, P<0.001)& greater reduction in impact of disease on work productivity (1.82& 2.64 vs. 0.78, P<0.001) versus PBO-treated patients, respectively.

CONCLUSIONS:

Ustekinumab improves general as well as arthritis &skin-related QoL, &reduces the impact of disease on work productivity in patients with active PsA.