Treatment with Humira (adalimumab) increases work productivity, reduces sleep problems, and eases disease activity in people with ankylosing spondylitis (AS) and related diseases, a new real-world study indicates.
The study, “Real-world evidence of the impact of adalimumab on work productivity and sleep measures in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis,” was published in Therapeutic Advances in Musculoskeletal Disease.
AS, psoriatic arthritis (PsA), and rheumatoid arthritis (RA) are all characterized by increased inflammation in the joints. In all these conditions, symptoms can limit a person’s ability to function in the workplace. Sleep problems are also common among patients — and these disturbances likely compound other physical and mental symptoms, further impairing function.
Humira is a tumor necrosis factor inhibitor, a type of medication that works by blocking pro-inflammatory signaling, thereby reducing inflammation. It is marketed by AbbVie; biosimilars of the medication have also been approved.
In the new study, which was sponsored by AbbVie, researchers reported results from a clinical trial (NCT01282372) that enrolled 500 participants at multiple centers in Greece between March 2011 and July 2012. This trial, called AWARE, “represents the largest study to have collected real-world data relating to work productivity and sleep disturbance measures of moderate to severe RA, PsA, and AS in patients treated with adalimumab [Humira] in routine care settings in Greece,” the researchers wrote.
Of the participants, 150 had AS, 184 had RA, and 166 had PsA. Median age at enrollment was 52 years, and 57.8% were female. All participants were treated with adalimumab, in addition to other standard treatments, as directed by their healthcare providers.
At regular intervals, participants completed the Work Productivity and Activity Impairment–General Health questionnaire (WPAI) and the Medical Outcomes Study Sleep Scale (MOS-SS), which assesses sleep problems. Relevant measures of disease activity were also assessed.
Of the 500 patients, 421 (84.2%) completed the planned two-year observation period. Among those who did not complete the study, the most common reason was stopping treatment.
Over the course of the study, multiple work-related measurements showed improvement across patients with any of the three disorders. For instance, the proportion of participants who reported absenteeism (work time missed due to health) decreased by 18.9% after two years. Likewise, presenteeism — health-related impairment while working — decreased by 40% and overall work productivity impairment by 46.8%.
Notably, reduced work impairment was statistically associated with lower disease activity.
Mean MOS-SS sleep disturbance scores decreased significantly during the study — from 50.9 to 16.6, indicating lessened disturbances. Also, scores for sleep problems decreased from 47.7 to 16.6.
Significant decreases were also seen in scores measuring somnolence (drowsiness), snoring, and waking up with shortness of breath. In contrast, ratings of sleep quantity and quality increased. These benefits were similar across the AS, PsA, and RA subgroups.
As with work impairment, better sleep correlated with less disease activity.
Over the course of the study, 121 treatment-related adverse events were reported in 12% of the patients. Most (97) were not serious. Among serious adverse events, most were classified as general disorders and injection site reactions, and included events such as fever and physical weakness.
One participant died due to stomach cancer, which was deemed unrelated to Humira. Overall, the study did not identify any new safety concerns related to the medication.
Overall, “adalimumab [Humira] lowered disease activity and reduced the work time missed and overall work impairment while also improving sleep problems across patients with RA, PsA and AS through 2 years of treatment,” the researchers concluded.
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