Most patients diagnosed with rheumatoid arthritis (RA) and treated with biologics during the new biologic treatment era exhibited clinical remission or low disease activity at initial follow-up, according to data from a study published in the Journal of Rheumatology.
Since their introduction, biologic disease-modifying antirheumatic drugs (DMARDs) have had a major influence on treatment for patients diagnosed with RA. To combat a lack of real-life data on long-term clinical outcomes in those treated with biologic DMARDs, Glenn Haugeberg, MD, PhD, of the Department of Rheumatology at the Hospital of Southern Norway Trust and professor at the Norwegian University of Science and Technology, and colleagues conducted a prospective, long-term observational study of patients at a rheumatology outpatient clinic in Norway.
“To our knowledge, this is the first study providing long-term data on clinical and radiographic outcomes in patients with early RA diagnosed and followed in the first decade of the biologic treatment era,” wrote Dr Haugeberg and colleagues.
Study participants were consecutively enrolled in the study between 1999 and 2001. Researchers collected data including demographic characteristics, disease activity, patient-reported outcomes, and treatments. Radiographs of participants’ hands and feet were obtained at baseline, 6 months, and 2, 5, and 10 years follow-up and scored according to the Sharp/van der Heijde method, yielding a modified total Sharp score (mTSS). A composite Disease Activity Score (DAS) and erythrocyte sedimentation rate (ESR)–collectively DAS28-ESR3–was also calculated for each patient.
A total of 94 patients were included in the study. At baseline, 67.8% were considered rheumatoid factor (RF) positive; when tested during follow-up for anti-citrullinated protein antibody (ACPA, n=83), 66.3% were positive. Among the patients with RA (n=76) who had baseline radiographs performed, researchers discovered erosions in 69.7% of patients (n=53).
Across all follow-up assessments, researchers found significantly increased radiographic joint damage, and mTSS scores showed a statistically significant difference in annual change between the 0-to-2 year and the 2-to-5 year, 5-to-10 year, and 2-to-10 year time periods. The percentage of patients receiving no treatment was higher at 5-year and 10-year visits than during visits conducted at 6 months. Among those patients DAS28-ESR3 declined from 3.95 at 6 months to 3.47, 3.11, and 2.43 at 2-year, 5-year, and 10-year visits, respectively. At study inception, only 5% of patients were in remission or had low disease activity status; at 10 years, 73% of patients met this standard. “Improvement was also seen for other measures reflecting disease activity,” said Dr Haugeberg.
“Our data suggest that the favorable outcome is attributed to the aggressive treatment in our patient cohort, with a large proportion of patients treat with prednisolone, synthetic DMARD, and biologic DMARD as monotherapy or in various combinations,” wrote Dr Haugeberg. “Despite all the limitations”–a small number of patients recruited from only one clinic, lack of treatment standardization during follow-up, and unequal visits between time periods–“our study reflects the clinical outcome in a group of patients with early RA treated in an ordinary daily clinical practice with easy access to biologic DMARD in the new millennium.”
Haugeberg G, Bøyesen P, Helgetveit K, et al. Clinical and radiographic outcomes in patients diagnosed with early rheumatoid arthritis in the first years of the biologic treatment era: a 10-year prospective observational study. J Rheumatol. 2015. doi: 10.3899/jrheum.150384.