Ustekinumab in psoriatic arthritis: need for studies from real-world evidence

Figures & data

Table 1. Main real-world evidence studies with ustekinumab.

Author, year	Design, patients and study period	Prior use of BT	Main results	Other outcomes
Napolitano, 2017	Single center, observational, prospective. N: 34 (23 ♂, 11 ♀) Jan–Dec 2015	1 TNFi: 70.5% 2 TNFi: 17.4% 3 TNFi: 29.4%	MDA: 70.5% at W24	Significant ↓: TJC, SJC, PASI, BSA, pain, TEP, HAQ.
Almirall, 2017	Multicenter, observational, retrospective. N: 58 (33 ♂, 25 ♀) 2009–2015	TNF-IR: 82.8% ≥ 2 TNFi: 54.2%	14 out of 30 patient with DAS28 measurement in clinical remission (DAS28 ≤ 2.6)	Discontinuation associated with obesity and number of prior BT
Chimenti, 2018	Multicenter, observational, prospective. N: 65 (28 ♂, 37 ♀) 2015–17	UST 1st line: 20% 2nd line:33.8% 3rd line: 26.5% 4th line: 15.4% 5th line: 4.6%	MDA: 30.7% (6 Mo) 47% (12 Mo) 34% (24 Mo) MDA Predictors: Mono-oligoarthritis	Significant ↓: TJC, SJC, PASI, LEI, Pain, BASDAI, HAQ
Iannone, 2018	Biologic registry (BIOPURE). N: 160 (76 ♂, 84 ♀). 2014–16.	1st line: 33.8% 66.2% TNF-IR	DAPSA rem. (biologic-naïve): 34% DAPSA rem. (TNF-IR): 17% 12-month drug survival significantly higher in naïve (87%) than in TNF-IR (68%)	Significant ↓: HAQ, PASI. Naïve patients had the lowest risk of UST discontinuation (HR 0.27, p = 0.01)
Queiro, 2018	Single center, observational, retrospective. N: 50 (27 ♀, 23 ♂) 2015–2017	1st line: 18% 1 TNFi: 52% ≥ 2 TNFi: 30%	MDA: 54% Predictors: Lower basal PASI, longer use of UST, previous failure to one TNFi	Significant ↓: PASI, HAQ, PsAID. 70.4% reached patient-acceptable symptoms state

N: number of patients, BT: biologic therapy, TNFi: tumoral necrosis factor inhibitors, MDA: minimal disease activity, W: week, TJC: tender joint count, SJC: swollen joint count, PASI: psoriasis area and severity index, BSA: body surface area, TEP: tender entheseal points, HAQ: health assessment questionnaire, TNF-IR: tumoral necrosis factor-inadequate responders, DAS: disease activity score, Mo: months, LEI: Leeds enthesitis index, BASDAI: Bath ankylosing spondylitis disease activity index, DAPSA: disease activity in psoriatic arthritis, rem: remission, HR: hazard ratio, UST: ustekinumab, PsAID: psoriatic arthritis impact of disease.

Figure 1. Proposed algorithm for positioning different therapeutic options in PsA patients.

Poor prognostic factors:- High number of actively involved joints- Radiographic damage- Elevated acute phase reactants- DactylitisPsA; Psoriatic Arthritis; csDMARDS: conventional synthetic Disease-Modifying AntireumaticDrugs; Tbc: Tuberculosis; ANA: Antinuclear Antibodies