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Supplementary material for publication online only: Effectiveness of adalimumab in treating patients with active psoriatic arthritis (PsA) and predictors of good clinical responses for arthritis, skin, and nail lesions METHODS Inclusion/exclusion criteria Main inclusion criteria were: age ≥18 years, PsA diagnosed by a rheumatologist; ≥3 tender and ≥3 swollen joints, previous treatment with ≥1 disease-modifying antirheumatic drugs (DMARDs); and enrollment in accordance with each participating country’s current guidelines for anti-TNF treatment of PsA. Allowed current antirheumatic medications: DMARDs, nonsteroidal anti-inflammatory drugs, and oral glucocorticoids (≤10 mg prednisolone equivalent/d), as well as topical psoriasis therapy, if the dosage was stable. Exclusion criteria were: medication prior to enrollment as follows: etanercept within ≤3 weeks, infliximab within ≤2 months, combination of methotrexate (MTX) and leflunomide (LEF) within ≤4 weeks, any combination of cyclosporine and another DMARD within ≤4 weeks, and ultraviolet A (UVA) phototherapy, including psoralen (PUVA) within ≤2 weeks. Further exclusion criteria encompassed a history of rheumatic disorders other than PsA; any uncontrolled medical condition that would put the patient at risk (eg, diabetes mellitus, ischemic heart disease); history or signs of demyelinating disease; active tuberculosis (TB) or histoplasmosis; malignancy (except for treated squamous or basal cell carcinoma); positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus; and infections requiring hospitalisation or intravenous antibiotics within 30 days or oral antibiotics within 14 days of enrolment. Patients diagnosed with latent TB by the Mantoux tuberculin skin test, T-SPOT.®TB test, or chest radiograph or with medical history suggesting risk factors for TB were excluded unless prophylactic therapy for latent TB was initiated before the first adalimumab injection. Study design STEREO (The SafeTy and Efficacy of Adalimumab in Patients With Active Psoriatic Arthritis — An Open-Label, Multinational Study to Evaluate the Response to EveryOther Week Adalimumab When Added to Insufficient Standard Therapy Including Patients Who Failed Prior Treatment With Other TNF Inhibitors) was a prospective, open-label, uncontrolled study conducted in nine European countries. Patients selfadministered adalimumab (Abbott Laboratories, Abbott Park, IL) 40 mg subcutaneously every other week in addition to their pre-existing antirheumatic treatments for 12 weeks. Subsequently, patients who benefited from adalimumab therapy could continue up to Week 20 if adalimumab was not commercially available. Evaluations for effectiveness and safety were conducted at Weeks 2, 6, 12, and 20, as applicable. Observed data at Week 12 were used for all effectiveness analyses, and safety data were analysed based on the complete treatment period of each patient. Data were analysed using SAS version 8.2 (SAS Inc., Cary, NC). Adverse events (AEs) were captured from the time of first adalimumab injection until 70 days (5 serum half-lives) following the last adalimumab injection. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA version 9.1). RESULTS Effectiveness Supplementary Table 1 Observed improvement in PsA signs and symptoms from baseline to Week 12 Baseline Effectiveness measure Tender joint count (0–78) Swollen joint count (0–76) DAS28 CRP (mg/dL) Erythrocyte sedimentation rate (mm/first hr) PaGA of disease activity (0–100 mm VAS) PhGA of disease activity (0–100 mm VAS) Week 12 Mean n Mean±SD change±SD 414 8.1±12.1 –11.7±11.8 Mean % change from baseline –61 n 442 Mean±SD 20.1±14.4 442 10.3±7.7 414 2.5±3.9 –7.6±6.9 –73 416 441 419 4.9±1.2 1.7±1.9 23±20 406 405 408 2.7±1.4 0.6±1.0 11±13 –2.3±1.4 –1.1±1.8 –12±17 –45 –26 –36 439 61±20 412 28±25 –32±29 –49 442 50±19 411 17±16 –33±21 –59 Patient’s assessment 439 64±21 412 28±25 –35±29 –51 of pain (0–100 mm VAS) HAQ DI (0–3) 439 1.24±0.62 412 0.71±0.66 –0.52±0.52 –47 DLQI (0–30)* 310 7.9±6.9 263 3.0±4.0 –4.6±5.8 –41 *Only patients with DLQI >0 at baseline. CRP, C-reactive protein (reference value, 0.4 mg/dL); DAS28, Disease Activity Score based on 28-joint count, erythrocyte sedimentation rate, and patient’s general health; DLQI, Dermatology Life Quality Index; HAQ DI, Health Assessment Questionnaire Disability Index; PaGA, Patient’s Global Assessment of disease activity; PhGA, Physician’s Global Assessment of disease activity; VAS, visual analogue scale. Predictors of good clinical response at Week 12 Supplementary Table 2 Crude odds ratios for good clinical responses to adalimumab at Week 12, as defined by ACR50 or good EULAR response ACR50 Good EULAR Predictors OR 95% CI P-Value OR 95% CI P-Value Sex (male vs. female) 2.40 1.61–3.57 <0.001 2.42 1.59–3.69 <0.001 HAQ-DI (per unit) 0.52 0.37–0.72 <0.001 0.53 0.37–0.76 <0.001 Treatment with SSZ* 1.86 1.01–3.43 0.050 2.89 1.35–6.17 0.006 Systemic glucocorticoids (≤10 0.64 0.42–0.98 0.050 0.49 0.31–0.77 0.002 mg/day)* Dactylitis* 1.22 0.78–1.93 0.421 1.76 1.14–2.72 0.012 CRP (per mg/dL) 1.01 0.91–1.13 0.821 1.14 1.02–1.27 0.017 SJC [0–76] (≥5 vs.<5) 1.12 0.64–1.96 0.670 2.37 1.38–4.09 0.002 ≥1 inflamed big joint* 0.98 0.66–1.44 0.921 0.59 0.39–0.89 0.015 Prior anti-TNF 0.65 0.37–1.13 0.162 0.45 0.25–0.80 0.007 therapy* Prior DMARD use (≥2 1.04 0.68–1.60 0.913 2.03 1.29–3.19 0.002 vs. <2) Age (per year) 0.99 0.97–1.00 0.136 0.97 0.96–0.99 0.005 Treatment with 1.02 0.67–1.56 1.000 1.36 0.87–2.11 0.176 DMARDs* PsA duration (per year) 1.00 0.98–1.03 0.826 1.01 0.98–1.03 0.704 Arthritis duration (per 1.01 0.98–1.03 0.593 1.00 0.98–1.03 0.805 year) Tobacco use ever vs. 0.81 0.55–1.20 0.320 1.04 0.69–1.57 0.916 never Enthesitis* 1.28 0.85–1.92 0.253 0.97 0.63–1.50 0.912 DAS28 1.10 0.92–1.32 0.316 0.90 0.75–1.09 0.277 PaGA of disease 1.00 0.99–1.01 0.363 1.00 0.99–1.01 0.480 activity (per mm) PhGA of disease 1.01 1.00–1.02 0.238 1.00 0.99–1.01 0.742 activity (per mm) Pain (per mm) 1.01 1.00–1.01 0.268 1.00 0.99–1.01 0.724 PGA >moderate vs. 1.23 0.70–2.15 0.482 0.94 0.51–1.72 0.877 ≤moderate Bold figures=statistically relevant. *Yes vs. no. PsA, psoriatic arthritis; ACR50, American College of Rheumatology response criteria 50% improvement; Good EULAR, European league against rheumatism Good Response criteria; DMARDs, disease modifying anti-rheumatic drugs; OR, odds ratio; CI, confidence interval; CRP, C-reactive protein (reference value, 0.4 mg/dL); OR, odds ratio; SSZ, sulfasalazine; VAS, visual analogue scale; HAQ-DI, health assessment questionnaire disability index; large joints, swollen shoulder, elbow, or knee or tender hip; DAS28, Disease Activity Score based on 28-joint count; PaGA, Patient’s Global Assessment; PhGA, Physician’s Global Assessment; PGA, Physician’s Global Assessment of psoriasis. Safety At least one AE was reported for 310 (70.1%) patients during adalimumab treatment and the 70-day follow-up. Twenty-one serious AEs were documented in 18 (4.1%) patients. Three (0.7%) patients experienced four serious infections: one 65-year-old female experienced TB laryngitis 13 weeks and urosepsis 24 weeks after the first adalimumab injection. The two other serious infections were primary atypical pneumonia and tooth abscess. One patient had a serious toxic hepatitis. No malignancies, lupus-like reactions, congestive heart failures, or demyelinating diseases were reported in this study.