Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT)

Abstract

Objective:To evaluate the long-term effectiveness and tolerability of adalimumab in the treatment of psoriatic arthritis (PsA).Methods:Patients with PsA who completed a 24-week, double-blind study of adalimumab versus placebo were eligible to enroll in an open-label extension study and receive adalimumab 40 mg subcutaneously every other week for up to an additional 120 weeks. At the time of this analysis, available efficacy evaluations throughout 2 years of treatment (n = 245) included American College of Rheumatology (ACR) 20%, 50% and 70% improvement scores, measures of joint disease and skin disease, disability and quality of life; modified total Sharp scores (mTSS) were available for 2.75 years of treatment for patients who received adalimumab in the 24-week study.Results:After 24 weeks of double-blind treatment, the mean change in mTSS was −0.2 for the adalimumab group (N = 144) and 1.0 for the placebo group (N = 152; p<0.001), and outcomes for all individual ACR component variables were significantly improved in adalimumab compared with placebo-treated patients. Compared with 24-week responses, inhibition of radiographic progression and improvements in joint disease were maintained in most patients during long-term, open-label adalimumab treatment. Also, improvements in skin disease were maintained, with >20% of patients achieving the strict criterion of psoriasis area and severity index 100. The nature and frequency of adverse events during long-term adalimumab treatment were consistent with the safety profile during short-term treatment.Conclusions:The clinical and radiographic efficacy of adalimumab demonstrated during short-term treatment was sustained during long-term treatment. Adalimumab has a favourable risk–benefit profile in patients with PsA.Trial registration number:NCT00195689.

Differential Adverse Events Between TNF-α Inhibitors and IL-17 Axis Inhibitors for the Treatment of Spondyloarthritis

“…After nearly 3 years of follow-up, the most common AE in the adalimumab trial in PsA patients were similar to those in the first 6 months of the study: upper respiratory tract infections, nasopharyngitis, and sinusitis were seen in 21.5, 17.4, and 10.7 %, respectively [8]. Similar AE were seen in AS patients in the ATLAS trial over a period of 2 years [9].…”

“…Transient elevation of liver enzymes was seen with adalimumab [8], certolizumab [22], and golimumab [23]. Similarly, in the golimumab study of PsA patients, Kavanaugh et al noted hyperbilirubinemia in study patients [24].…”

“…In addition, rates of demyelinating disorders, lymphomas, and solid tumors have been noted to be increased in populations using these medications [6]. Availability of TNF-α inhibitors on the commercial market for a prolonged period of time has provided information about long-term safety from post-marketing surveillance, registries, long-term follow-up studies, and voluntary reporting [4•, 7••, [8][9][10]. Table 1 outlines side effects, malignancies, opportunistic infections, and deaths for each drug included in this review.…”

Effectiveness and Safety of Etanercept in Patients with Psoriatic Arthritis in a Canadian Clinical Practice Setting: The REPArE Trial

“…While traditional disease-modifying antirheumatic drugs (DMARD) such as methotrexate appear to offer limited protection from ongoing joint damage in PsA 15 , a newer group of biologic agents, the tumor necrosis factor (TNF) inhibitors, can halt radiographic progression over a period of weeks to years 16,17,18,19 . There are currently 4 TNF inhibitors available to Canadian physicians for treating PsA: etanercept 17,19,20,21,22,23 , infliximab 18,24 , adalimumab 16,25,26 , and golimumab 27 .…”

Abatacept in the treatment of patients with psoriatic arthritis: Results of a six‐month, multicenter, randomized, double‐blind, placebo‐controlled, phase II trial

“…Nonbiologic disease-modifying antirheumatic drugs (DMARDs), methotrexate (MTX) in particular, are the first-choice treatment of PsA, despite disappointing efficacy in clinical trials (7). Recent studies have demonstrated that tumor necrosis factor (TNF) inhibitors are efficacious against both the psoriatic and the arthritic components of PsA (8)(9)(10)(11)(12)(13)(14)(15)(16).…”