Table 15Studies assessing adverse events, discontinuation rates, and adherence in psoriatic arthritis

StudyStudy Design
Duration
Study PopulationDrugResultsQuality Rating
Oral DMARDs
Kaltwasser et al., 200441RCT
190
24 weeks
Patients with active PsALEFDifferences in rates of withdrawals because of adverse events, diarrhea, and clinically significant increases in ALT (for all, P=NR). Compliance of ≥ 80% to<110%:LEF, 85%; placebo, 78%Fair
Ravindran et al., 200845*Meta-analysis
SFZ: five studies
LEF: one study
Placebo-controlled RCTs of oral or biological DMARDs for patients with PsALEF, SFZWithdrawals due to adverse events vs. placebo:
LEF: RR 3.86 (1.2–12.39)
SFZ: RR 1.76 (0.98–3.14)
Fair
Biologic DMARDs
Antoni et al., 200550
IMPACT study
RCT
104
16 weeks
Patients with active PsA despite background biologic or synthetic DMARD treatmentINFNo statistically significant differences in adverse eventsFair
Antoni et al., 200552
IMPACT2 study
RCT
200
24 weeks
Patients with active PsA despite background biologic or synthetic DMARD treatmentINFNo statistically significant differences in adverse eventsFair
Genovese et al., 200756*RCT
102
12 weeks
Patients with active PsA despite synthetic DMARD treatmentADAMore adverse events for placebo (79.6%) than ADA (52.9%); P ≤ 0.01. Aggravation of psoriasis more common for placebo (16.3%) than ADA (3.9%); P ≤ 0.05Fair
Kavanaugh et al., 200954
GO-REVEAL*
RCT
405
24 weeks
Patients with active PsA despite synthetic DMARD or NSAID treatmentGOLInfections and malignancies more common with GOL than placebo (for all, P=NR)Fair
Kristensen et al., 200843*Prospective cohort
261
12 months
Patients with active PsA, biologic DMARD naïveADA, ETN, INF, MTXConcomitant MTX associated with significantly fewer withdrawals due to adverse events HR, 0.25; 95% CI, 0.11 to 0.52; P<0.01). Compared with INF, ETN had lower risk of withdrawals due to adverse events (HR, 0.30; 95% CI, 0.11 to 0.80, P=0.02)Fair
Mease et al., 200047RCT
60
12 weeks
Patients with active PsA despite background biologic or synthetic DMARD treatmentETNNo statistically significant differences in adverse events except for ISRs.
ETN 20% vs. placebo 3% (P=NS)
Fair
Mease et al., 200562RCT
313
24 weeks
Patients with active PsA despite background biologic or synthetic DMARD treatmentADANo statistically significant differences in adverse events except for ISRs.
ADA 6.6% vs. placebo 3.1% (P=NR)
Fair
Mease et al., 200649RCT
205
72 weeks (24 blinded, 48 open label)
Patients with active PsA despite background biologic or synthetic DMARD treatmentETNNo statistically significant differences in adverse events except for ISRs.
ETN 20% vs. placebo 9% (P<0.001)
Fair
Ravindran et al., 200845*Meta-analysis
TNF-inhibitors: five studies
Placebo-controlled RCTs of oral or biological DMARDs for patients with PsAADA, ETN, INFWithdrawals due to adverse events vs. placebo:
TNF Inhibitors: RR 2.2 (0.82–5.91)
Fair
Saad et al., 200963*Observational
566
3 years
Patients from the British Society for Rheumatology Biologics Register (BSRBR) with PsAADA, ETN, INFWithdrawals due to adverse events: ADA 14.8%, ETN 12.3%, INF 23.5%. Hazard ratio for INF vs. ETN 3.1 (95% CI, 1.4 to 6.2)Good

ADA = adalimumab; ALT = alanine aminotransferase; DMARD = disease-modifying antirheumatic drug; ETN = etanercept; GOL = golimumab; HR = hazard ratio, INF = infliximab; ISR = injection-site reaction; LEF = lefluonomide; MTX = methotrexate; NR = not reported; NS = not significant; NSAID = nonsteroidal anti-inflammatory drugs; PsA = psoriatic arthritis; RCT = randomized controlled trial; RR = relative risk; SFZ = sulfasalazine; TNF = tumor necrosis factor

*

New studies added since last review.

From: Results

Cover of Drug Therapy for Psoriatic Arthritis in Adults: Update of a 2007 Report
Drug Therapy for Psoriatic Arthritis in Adults: Update of a 2007 Report [Internet].
Comparative Effectiveness Reviews, No. 54.
Donahue KE, Jonas D, Hansen RA, et al.

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