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LONDON — In early peripheral spondyloarthritis (pSpA), immediate use of a TNF inhibitor (TNFi) resulted in a 27% higher clinical remission rate at 24 weeks than ‘stepping-up’ conventional synthetic disease-modifying antirheumatic drug (csDMARD) treatment with methotrexate in the phase 3 SPARTACUS trial.

Clinical remission, which was defined as the complete absence of arthritis, dactylitis, or enthesitis on clinical examination, was recorded in three fifths (60%) of the 48 study participants who were treated with golimumab in the TNFi induction group and in one third (33%) of the 49 participants who were in the csDMARD step-up group (P = .003).

TNFi induction over step-up csDMARDs also resulted in greater mean changes from baseline in the Disease Activity in Psoriatic Arthritis (DAPSA) Score and Axial Spondyloarthritis Disease Activity Score based on C-reactive protein (ASDAS-CRP).

“These data support the importance of early diagnosis and early treatment before structural damage,” Wilson Bautista-Molano, MD, PhD, University Hospital Fundación Sante Fe de Bogotá in Bogotá, Colombia, told Medscape Medical News at the European Alliance of Associations for Rheumatology (EULAR) 2026 Annual Meeting.

Bautista-Molano, who was not involved in the study, added: “It’s a very interesting work, looking for a window of opportunity in spondyloarthritis.” There are several trials ongoing in this area to see if earlier treatment could help to “avoid radiographic progression, more physical involvement, and loss of quality of life,” he added, and said the results were “highly valuable” for clinical practice.

SPARTACUS Trial Rationale

Philippe Carron, MD, PhD, of Ghent University Hospital in Ghent, Belgium and one of the SPARTACUS trial’s principal investigators, told Medscape Medical News: “There is a huge lack of efficacy data in peripheral spondyloarthritis, particularly as compared to axial disease or psoriatic arthritis.”

Rheumatologists are seeing people with pSpA with very swollen joints in their practices quite frequently, but there are no advanced therapies that have been approved by the FDA or the European Medicines Agency specifically for pSpA, Carron said.

The current approach is to start treatment with nonsteroidal anti-inflammatory drugs then add in a csDMARD such as methotrexate or sulfasalazine. TNFi are reserved for refractory disease, but this puts people at lifelong need for therapy, with many not achieving a good response.

“One of the main reasons why we performed SPARTACUS was there were no data at all regarding the efficacy of methotrexate in peripheral spondyloarthritis, yet we are using it in daily practice,” he said.

Another reason is that there are also limited data for TNFi use in pSpA. Prior to the SPARTACUS trial, the available evidence was from trials such as CRESPA (Clinical REmission in peripheral SPondyloArthritis) that used a placebo control group and included people with very early symptoms of 12 weeks or less.

“So we wanted to repeat that [study] in a patient population with a symptom duration of a maximum of 1 year, extending what we are doing in CRESPA, and we wanted to have an active comparator,” Carron explained.

SPARTACUS Trial Study Design

The SPARTACUS trial was set up to see if long-term drug-free remission could be achieved with early TNFi induction therapy or a standard csDMARD step-up strategy in people with newly diagnosed, early active pSpA.

The study population included 97 patients who had pSpA as defined by Assessment of Spondyloarthritis International Society classification criteria with symptoms that had lasted for less than 1 year.

For inclusion, participants had to have arthritis, enthesitis, or dactylitis, plus at least one additional feature of spondyloarthritis. Carron reported that, at baseline, 97% of the overall cohort had arthritis, 68% had enthesitis, and 34% had dactylitis. The mean age was 39 years and 60% of the population were men. Just under half (45%) were HLA-B27 positive, and 51% had a history of psoriasis. The mean symptom duration was 5.9 months.

Participants randomly allocated to the TNFi induction group were treated with golimumab at a subcutaneous dose of 50 mg every 4 weeks. Those in the csDMARD step-up group received oral methotrexate at an initial weekly dose of 15 mg, which was increased to 20 mg/week after 4 weeks if it was tolerated. If it was not, the prior or a lower dose of methotrexate could be used, or patients could be switched to the TNFi.

After 12 weeks, participants in clinical remission continued their allocated treatment for a further 12 weeks. Those not in clinical remission completed the Patient Acceptable Signs and Symptoms Improvement instrument, and if responses indicated the current treatment was not sufficiently addressing symptoms, daily oral treatment with sulfasalazine (2 g) was added.

Peripheral Spondyloarthritis Symptoms Eased

As reported in the abstract, the odds ratio for clinical remission at week 24 was 3.1 (P = .006) in favor of the TNFi induction strategy. Additionally, 42% of the TNFi-treated participants achieved sustained clinical remission at 24 weeks compared with 18% of the csDMARD-treated group (P = .006).

The proportion of patients achieving resolution of arthritis, enthesitis, and dactylitis was also higher in the TNFi induction group than in the csDMARD step up group and was apparent starting from week 8 and continuing to week 24.

A similar pattern was seen for DAPSA and ASDAS-CRP, with greater reductions seen with TNFi from week 8 onward vs methotrexate continued to week 24.

CRP was high in both groups at baseline at a mean level of 25 mg/L overall, but both treatments lowered CRP to a similar degree to approximately 5 mg/L.

Exploratory analysis showed that fewer patients in the TNFi induction group needed “rescue medication” with sulfasalazine at 12 weeks than those in the methotrexate group (8.3% vs 28.6%; P = .02).

Carron reported that one patient in the TNFi induction group experienced a serious adverse event involving flu-like symptoms that required hospitalization. Otherwise, he reported no serious adverse events or safety signals during the first 24 weeks in either treatment group.

“The main message is that there is superiority of immediately using anti-TNF vs methotrexate,” Carron said in an interview.

“A second one is that methotrexate is actually doing something. This is this first time that it is shown [to have an effect] in peripheral spondyloarthritis, so that is also encouraging because we are doing that in daily practice.”

The SPARTACUS trial was sponsored by Ghent University Hospital with support from Vlaams Instituut voor Biotechnologie and Merck Sharp & Dohme.

Carron reported receiving speaker or consulting fees from AbbVie, UCB, Eli Lilly and Company, Novartis, Janssen, and Alfasigma, and research support from Pfizer.

Bautista-Molano reported having no relevant financial relationships.

Sara Freeman, BSc, MSc, is a freelance medical journalist based in London, England. She has been reporting for specialist healthcare news organizations for more than 20 years.