10-Year Data Back Early Start to Biologics in Arthritic Diseases

Many patients treated with golimumab (Simponi) for newly diagnosed peripheral spondyloarthritis (pSpA) in a small trial achieved sustained drug-free remission after 10 years of follow-up, researchers found.

With 49 of the trial’s original 60 patients available at year 10, more than 30% were in clinical remission with no use of disease-modifying antirheumatic drugs (DMARDs), according to Philippe Carron, MD, PhD, of Ghent University in Belgium, and colleagues.

Drug-free remission rates were especially high in patients without psoriasis, the group reported in Arthritis & Rheumatology: a whopping 48% at year 10, as opposed to just 13% among those with psoriasis at baseline.

Carron and colleagues looked for other baseline factors that predicted success and found none, they noted.

“These findings support the existence of a ‘window of opportunity’ for intervention, with profound implications for clinical practice at both the patient and societal level,” the researchers wrote.

The 2010s saw great ferment in rheumatology, with a host of new biologic and other targeted drugs hitting the market. Along with this expansion in treatment options came interest in whether using them early in the disease process would increase chances of long-term remission. Many trials were undertaken, and the results suggested that this could indeed be an effective strategy, although the “number needed to treat” remained too high for early aggressive (and expensive) therapy to become the standard of care.

Among those trials was CRESPA, also led by Carron with primary results reported in 2017. It randomized 60 patients with newly diagnosed pSpA to 6 months of the tumor necrosis factor inhibitor golimumab or placebo, in a 2:1 ratio. Peripheral SpA is a catchall for a variety of inflammatory arthritic conditions, distinct from rheumatoid arthritis (RA) but also primarily affecting limb joints and related tissues. Psoriatic arthritis is the most common pSpA disorder, while others are associated with inflammatory bowel disease or intestinal infections. Progression to axial SpA often occurs.

Primary findings in CRESPA indicated that 53% were in sustained drug-free remission after 1 year, although nearly half of patients who stopped therapy suffered relapse after an average of 31 weeks. (Patients were considered “drug-free” if they weren’t taking DMARDs, but nonsteroidal anti-inflammatory drugs, or NSAIDs, were permitted.) Fifteen patients in the placebo group had switched to active golimumab at week 12 because of pSpA symptoms.

For the new analysis, Carron’s group contacted all the original participants that they could, eventually reaching 49 of them. Some who were unable to return to Ghent for in-person exams were evaluated remotely via telehealth and their own assessments. One of the original 60 was excluded after it was determined they had seronegative RA instead of pSpA.

Nine participants still had active disease at year 10. Another 25 were classified as being in clinical remission, but were still using DMARDs to maintain it. The remaining 15 were in remission with no DMARD treatment. Remission in this study was defined as a score of 4 or less on the 44-joint Disease Activity index for PSoriatic Arthritis (DAPSA44) instrument.

Carron and colleagues also had some data on the 10 participants they couldn’t find at year 10; they reported that six of them were off DMARDs as well as NSAIDs at their last visits, from 2015 to 2023.

Outcomes besides remission at year 10 were remarkably favorable irrespective of remission status. Nearly two-thirds of all 49 at year 10 said they had no mobility problems or difficulties with daily activities. Over 40% reported being pain-free. And of 43 participants of working age, 38 reported employment, although half of them admitted to limitations on the job, mostly mild.

Importantly, Carron and colleagues found that no patients discontinued golimumab because of continued arthritic symptoms. Thyroid cancer, however, forced one participant to stop the drug.

Limitations to the study included the small sample size and its single-center design. Also, with 15 of 20 patients in the placebo group switching to active therapy early in the trial, there was no real control group with which to compare long-term outcomes.