Skyrizi (Page 5 of 13)

14.2 Psoriatic Arthritis

The safety and efficacy of SKYRIZI were assessed in 1407 subjects in 2 randomized, double-blind, placebo-controlled studies (964 in PsA-1 [NCT03675308] and 443 in PsA-2 [NCT03671148]) in subjects 18 years and older with active psoriatic arthritis (PsA).

Subjects in these studies had a diagnosis of PsA for at least 6 months based on the Classification Criteria for Psoriatic Arthritis (CASPAR), a median duration of PsA of 4.9 years at baseline, ≥ 5 tender joints and ≥ 5 swollen joints, and active plaque psoriasis or psoriatic nail disease at baseline. Regarding baseline clinical presentation, 55.9% of subjects had ≥3% BSA with active plaque psoriasis; 63.4% and 27.9% of subjects had enthesitis and dactylitis, respectively. In PsA-1 where psoriatic nail disease was further assessed, 67.3% had psoriatic nail disease.

In PsA-1, all subjects had a previous inadequate response or intolerance to non-biologic DMARD therapy and were biologic naïve. In PsA-2, 53.5% of subjects had a previous inadequate response or intolerance to non-biologic DMARD therapy, and 46.5% of subjects had a previous inadequate response or intolerance to biologic therapy.

In both studies, subjects were randomized to receive SKYRIZI 150 mg or placebo at Weeks 0, 4, and 16. Starting from Week 28, all subjects received SKYRIZI every 12 weeks. Both studies included a long-term extension for up to an additional 204 weeks. Regarding use of concomitant medications, 59.6% of subjects were receiving concomitant methotrexate (MTX), 11.6% were receiving concomitant non-biologic DMARDs other than MTX, and 28.9% were receiving SKYRIZI monotherapy.

For both studies, the primary endpoint was the proportion of subjects who achieved an American College of Rheumatology (ACR) 20 response at Week 24.

Clinical Response

In both studies, treatment with SKYRIZI resulted in significant improvement in measures of disease activity compared with placebo at Week 24. See Tables 5 and 6 for key efficacy results.

In both studies, similar responses were seen regardless of concomitant non-biologic DMARD use, number of prior non-biologic DMARDs, age, gender, race, and BMI. In PsA-2, responses were seen regardless of prior biologic therapy.

Table 5. Efficacy Results in Study PsA-1
Endpoint Placebo N=481 Response Rate SKYRIZI N=483 Response Rate Difference from Placebo (95% CI)
ACR20 Response*
Week 16 33.4%56.3%a 23.1% (16.8, 29.4)
Week 24 33.5%57.3%a 24.0% (18.0, 30.0)
ACR50 Response*
Week 1611.1%26.4%15.4% (10.6, 20.2)
Week 2411.3%33.4%22.2% (17.3, 27.2)
ACR70 Response*
Week 162.7%11.8% 9.2% (6.1, 12.4)
Week 244.7%15.3%10.5% (6.9, 14.2)
a. multiplicity-controlled p≤0.001, SKYRIZI vs. placebo comparison.*A Subject was considered as a non-responder after initiation of rescue medication or concomitant medications for PsA that could meaningfully impact efficacy assessment.
Table 6. Efficacy Results in Study PsA-2
Endpoint Placebo N=219 Response Rate SKYRIZI N=224 Response Rate Difference from Placebo (95% CI)
ACR20 Response*
Week 16 25.3%48.3% a 22.6% (13.9, 31.2)
Week 24 26.5%51.3% a 24.5% (15.9, 33.0)
ACR50 Response*
Week 166.8%20.3%13.5% (7.3, 19.7)
Week 249.3%26.3%16.6% (9.7, 23.6)
ACR70 Response*
Week 163.4%11.2%7.8% (3.0, 12.6)
Week 245.9%12.0%6.0% (0.8, 11.3)
a. multiplicity-controlled p≤0.001, SKYRIZI vs. placebo comparison. *A Subject was considered as a non-responder after initiation of rescue medication or concomitant medications for PsA that could meaningfully impact efficacy assessment.

The percent of subjects achieving ACR20 responses in study PsA-1 through Week 24 is shown in Figure 1.

Figure 1. Percent of Subjects Achieving ACR20 Responses in Study PsA-1 through Week 24

Figure 1. Percent of Subjects Achieving ACR20 Responses in Study PsA-1 through Week 24
(click image for full-size original)

The results of the components of the ACR response criteria for both studies are shown in Table 7.

Table 7. Mean Change from Baseline in ACR Components
PsA-1 PsA-2
Placebo (N=481) Mean (SD) SKYRIZI (N=483) Mean (SD) Placebo (N=219) Mean (SD) SKYRIZI (N=224) Mean (SD)
Number of Swollen Joints (0-66)
Baseline12.2 (8.0)12.1 (7.8)13.6 (9.0)13.0 (8.7)
Mean change at Week 16-5.5 (7.0)-7.7 (7.2)-5.4 (8.5)-8.0 (7.4)
Mean change at Week 24-6.7 (7.2)-8.7 (7.2)-6.5 (7.8)-9.1 (7.6)
Number of Tender Joints (0-68)
Baseline20.5 (12.8)20.8 (14.0)22.3 (13.8)22.8 (14.9)
Mean change at Week 16-6.3 (11.1)-10.7 (11.4)-6.0 (13.1)-11.3 (13.0)
Mean change at Week 24-7.9 (10.7)-12.0 (12.3)-8.3 (11.3)-13.0(12.5)
Patient’s Assessment of Pain a
Baseline57.1 (22.6)57.1 (22.6)57.0 (23.1)55.0 (23.5)
Mean change at Week 16-8.6 (23.7)-18.4 (26.3)-5.7 (22.7)-14.4 (26.4)
Mean change at Week 24-10.9 (25.4)-21.4 (26.5)-8.7 (25.3)-15.3 (26.5)
Patient’s Global Assessment a
Baseline57.4 (22.1)57.9 (21.7)56.2 (23.0)56.2 (21.8)
Mean change at Week 16-10.2 (23.9)-19.4 (25.7)-4.9 (23.6)-17.0 (27.1)
Mean change at Week 24-11.1 (25.1)-22.6 (26.9)-8.7 (25.4)-17.7 (27.7)
Physician Global Assessment a
Baseline62.4 (17.0)61.3 (17.6)60.7 (16.4)63.0 (17.0)
Mean change at Week 16-18.3 (22.5)-31.1 (23.4)-19.0 (23.3)-32.7 (24.7)
Mean change at Week 24-22.2 (22.8)-34.8 (23.2)-21.3 (25.2)-35.5 (25.6)
Health Assessment Questionnaire — Disability Index (HAQ-DI) b
Baseline1.2 (0.7)1.2 (0.7)1.1 (0.6)1.1 (0.6)
Mean change at Week 16-0.1 (0.5)-0.3 (0.5)-0.1 (0.5)-0.2 (0.5)
Mean change at Week 24-0.1 (0.5)-0.3 (0.5)-0.1 (0.4)-0.2 (0.5)
High sensitivity C-reactive protein (hs-CRP) mg/L
Baseline11.3 (14.1)11.9 (15.9)8.2 (17.1)7.4 (10.9)
Mean change at Week 16-0.3 (14.7)-4.8 (14.2)-0.1 (6.8)-2.1 (7.5)
Mean change at Week 24-0.2 (11.7)-4.3 (12.8)-0.5 (14.5)-1.8 (13.4)
SD= Standard Deviation.a. Assessment based on Visual Analog Scale (100 mm) with the left end indicating “no pain” (for patient’s assessment of pain), “very well” (for patient global assessment), or “no arthritis activity” (for physician global assessment) and the right end indicating “the worst possible pain” (for patient assessment of pain), “poor” (for patient global assessment), or “extremely active arthritis” (for physician global assessment).b. Disability Index of the Health Assessment Questionnaire; 0 = no difficulty to 3 = inability to perform, measures the patient’s ability to perform the following: dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living.

Treatment with SKYRIZI resulted in improvement in dactylitis and enthesitis in subjects with pre-existing dactylitis or enthesitis.

In patients with coexistent plaque psoriasis receiving SKYRIZI, the skin lesions of psoriasis improved with treatment, relative to placebo, as measured by the Psoriasis Area Severity Index (PASI 90) at Week 24.

Physical Function

In both studies, patients treated with SKYRIZI showed statistically significant improvement from baseline in physical function compared with placebo as assessed by HAQ-DI at Week 24 (Table 5). The mean difference (95% CI) from placebo in HAQ-DI change from baseline at Week 24 was -0.20 (-0.26, -0.14) in study PsA-1 and -0.16 (-0.26, -0.07) in study PsA-2.

In both studies, a greater proportion of subjects achieved a reduction of at least 0.35 in HAQ-DI score from baseline in the SKYRIZI group compared with placebo at Week 24.

Other Health Related Outcomes

In both studies, general health status was assessed by the 36-Item Short Form Health Survey (SF-36 V2). Fatigue was assessed by Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue).

In both studies at Week 24, subjects treated with SKYRIZI showed improvements in the SF-36 physical component summary scores compared with subjects who received placebo. There were also numerical improvements in subjects treated with SKYRIZI in physical functioning, role physical, bodily pain, general health, vitality, social functioning, mental health, role emotional domain scores and mental component summary scores in both studies at week 24 compared to placebo. In both studies at Week 24, subjects treated with SKYRIZI showed improvements in FACIT-Fatigue scores compared with subjects who received placebo.

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