Unguided intra-articular betamethasone injections provide rapid and enduring control of inflammation in both small and large peripheral joints when used as a component of a treat-to-target strategy in patients with early rheumatoid arthritis, according to findings from the randomized, placebo-controlled trial.
The findings are among the first to systematically demonstrate efficacy and feasibility of intra-articular glucocorticoid injections when used in combination with disease-modifying antirheumatic drugs (DMARDs) in the setting of early rheumatoid arthritis (RA), Dr. Merete Lund Hetland of Copenhagen University Hospital and her colleagues wrote in a report published online in the Feb. 1 issue of Annals of Rheumatic Diseases.
|
Dr. Merete Lund Hetland
|
The 160 DMARD-naive patients who participated in the CIMESTRA (Ciclosporin, Methotrexate, Steroid in RA) study had early active RA of less than 6 months duration. They were randomized to receive either 7.5 mg-20 mg of methotrexate weekly plus 2.5 mg/kg per day of ciclosporin or methotrexate plus placebo-ciclosporin. Both groups were given intra-articular injections of 7 mg/mL of betamethasone in up to four swollen joints at baseline and at weeks 2, 4, 6, and 8, and then every 4 weeks thereafter for up to 2 years. Since the combination and monotherapy groups had similar clinical and radiographic outcomes, as well as a similar number of injections and cumulative betamethasone dose after 5 years, data from both treatment arms were pooled for the current analysis.
A total of 2,166 injections were given, including 1,373 first injections, 531 second injections, and 262 third injections. The median dose of betamethasone decreased from 28 mg at baseline to 0 mg at the following visits, and the cumulative dose after 2 years was 77 mg, which corresponds to less than 1 mg prednisolone daily. The median cumulative number of injections per patient was 13.
Within 2 weeks of the initial joint injections, the median 28-joint count Disease Activity Score (DAS28) had decreased from 5.5 to 3. By 6 weeks, the DAS28 had decreased to 2.6, the investigators wrote (Ann. Rheum. Dis. 2012 Feb. 1[doi:10.1136/annrheumdis-2011-200632]).
"Thus, the median number of swollen and tender joints had decreased sharply to 0 and 3, respectively, and remained low. By weeks 2, 4, and 6, respectively, 50%, 58.1%, and 61.7% of patients had achieved a good EULAR response, and 39%, 42%, and 47% were in DAS28 remission," they said.
The injections also provided good long-term efficacy. After 1 and 2 years, 62.3% and 55.5%, respectively, of the swollen joints injected at baseline had not relapsed.
An analysis by joint area showed that benefits of joint injection persisted at 2 years was 51.2% for elbows, 60.1% for ankles, 54.8% for wrists, 55.3% for knees, 52.3% for metacarpophalangeal (MCP) joints, 53.6% for metatarsophalangeal (MTP) joints, 49.5% for shoulders, and 73.7% for proximal interphalangeal (PIP) joints. Persistence of join injection benefits was significantly higher for first-time injections.
For example, the 1-year survival was 63.6% for first-time injections, compared with 48.7% and 32.4% for second and third injections, respectively. The 2-year survival for first-time injections was 56.6%, compared with 43.4% and 31.3% for second and third injections, respectively.
Submitting your vote...
Cancer