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

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 -20.2 for the adalimumab group (N = 144) and 1.0 for the placebo group (N = 152; p20% 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

Feasibility of Small Animal Anatomical and Functional Imaging with Neutrons: A Monte Carlo Simulation Study

A novel technique is presented for obtaining a single in-vivo image containing both functional and anatomical information in a small animal model such as a mouse. This technique, which incorporates appropriate image neutron-scatter rejection and uses a neutron opaque contrast agent, is based on neutron radiographic technology and was demonstrated through a series of Monte Carlo simulations. With respect to functional imaging, this technique can be useful in biomedical and biological research because it could achieve a spatial resolution orders of magnitude better than what presently can be achieved with current functional imaging technologies such as nuclear medicine (PET, SPECT) and fMRI. For these studies, Monte Carlo simulations were performed with thermal (0.025 eV) neutrons in a 3 cm thick phantom using the MCNP5 simulations software. The goals of these studies were to determine: 1) the extent that scattered neutrons degrade image contrast; 2) the contrasts of various normal and diseased tissues under conditions of complete scatter rejection; 3) the concentrations of Boron-10 and Gadolinium-157 required for contrast differentiation in functional imaging; and 4) the efficacy of collimation for neutron scatter image rejection. Results demonstrate that with proper neutron-scatter rejection, a neutron fluence of 2 ×107 n/cm2 will provide a signal to noise ratio of at least one ( S/N ≥ 1) when attempting to image various 300 μm thick tissues placed in a 3 cm thick phantom. Similarly, a neutron fluence of only 1 ×107 n/cm2 is required to differentiate a 300 μm thick diseased tissue relative to its normal tissue counterpart. The utility of a B-10 contrast agent was demonstrated at a concentration of 50 μg/g to achieve S/N ≥ 1 in 0.3 mm thick tissues while Gd-157 requires only slightly more than 10 μg/g to achieve the same level of differentiation. Lastly, neutr- n collimator with an L/D ratio from 50 to 200 were calculated to provide appropriate scatter rejection for thick tissue biological imaging with neutrons

Adalimumab improves joint‐related and skin‐related functional impairment in patients with psoriatic arthritis: patient‐reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial

OBJECTIVE: To evaluate the effects of adalimumab on patient‐reported outcomes of joint‐related and skin‐related functional impairment, health‐related quality of life , fatigue and pain in patients with psoriatic arthritis (PsA). METHODS: Patients with moderately‐ to severely‐ active PsA were treated with adalimumab, 40 mg, every other week, or placebo, in this 24‐week, randomised, controlled trial. Patient‐reported outcomes included the Health Assessment Questionnaire Disability Index (HAQ DI), Short‐Form 36 Health Survey (SF‐36), the Functional Assessment of Chronic Illness Therapy—Fatigue (FACIT‐Fatigue) Scale and the Dermatology Life Quality Index (DLQI). RESULTS: Adalimumab (n = 151) and placebo (n = 162) groups were comparable with respect to baseline demographics and disease severity. Significant changes from baseline in HAQ DI were reported for adalimumab v placebo (−0.4 v −0.1, p<0.001) at both 12 and 24 weeks. At week 24, significant improvements in the SF‐36 domains of physical functioning, role‐physical, bodily pain, general health, vitality and social functioning, as well as the physical component summary score, were observed for adalimumab versus placebo (p<0.01). These reported changes in HAQ DI and SF‐36 were also clinically important. Significantly more patients treated with adalimumab had complete resolution of functional loss (HAQ DI = 0) and dermatological‐related functional limitations (DLQI = 0) compared with placebo at weeks 12 and 24 (p⩽0.001). Adalimumab led to significantly greater improvements in FACIT‐Fatigue scores, pain scores, and disease activity measures versus placebo at 12 and 24 weeks (p<0.001 for all). CONCLUSIONS: Adalimumab improved physical‐related and dermatological‐related functional limitations, HRQOL, fatigue and pain in patients with PsA treated for 24 weeks