In the randomised DIPSA trial, 2 personalised dietary interventions and standard dietary advice all produced modest weight loss and improvements in psoriatic arthritis (PsA) disease activity, with no significant differences between approaches. The degree of weight loss, rather than the specific diet intervention, was most strongly associated with symptom improvement.
Diet has an ill-defined place as an adjunctive strategy in PsA, largely because randomised controlled trials in this population are scarce. As Prof. Lihi Eder (University of Toronto, ON, Canada) explained, DIPSA (NCT04180904), a multicentre randomised controlled trial, evaluated whether 2 personalised dietary interventions could improve clinical outcomes compared with standard of care in patients with active disease [1]. Overweight and obese adults (BMI 25-40 kg/m²) with moderately active PsA (Disease Activity Index for PsA (DAPSA) >10) receiving stable drug therapy were recruited from 3 centres between 2021 and 2024. Participants were randomised to 1 of 2 groups: a Mediterranean diet enriched with olive oil and nuts; a low-calorie diet, Dietary Approaches to Stop Hypertension diet (DASH-LC), aimed at weight reduction; or a standard-of-care control group that received general, non-personalised printed dietary advice. Registered dietitians delivered the interventions through 2 in-person consultations and 7 structured telephone sessions, with clinical assessments at baseline and weeks 12 and 24. The primary endpoint was the change in DAPSA at weeks 12 and 24.
Of 92 randomised patients (Mediterranean diet: n=31, DASH-LC: n=30, control: n=31), 12 withdrew after randomisation but remained in the intention-to-treat analysis. Baseline characteristics were comparable, with a mean age of 55±13 years, 70% female participants, a mean BMI of 33±4.3 kg/m², and a mean DAPSA score of 20±11. Overall, 72% of participants were receiving a biologic or targeted synthetic disease-modifying antirheumatic drug (tsDMARD), and 29% were receiving a conventional synthetic DMARD.
All 3 groups experienced modest but statistically significant weight loss by week 12 (Mediterranean diet: -1.36 kg; DASH-LC: -2.47 kg; control: -1.88 kg), with small additional reductions by week 24 and no significant differences between treatment groups. Significant reductions in DAPSA at week 12 were observed in the DASH-LC (-4.93) and control (-4.25) groups, while by week 24 all 3 groups had improved (Mediterranean diet: -4.87; DASH-LC: -5.42; control: -6.53), again without significant between-group differences. Minimal disease activity (MDA) at week 12 was achieved by 38% of patients in the DASH-LC group and 29% in the Mediterranean diet group compared with 16% in the control group (P=0.23 and P=0.06, respectively), although MDA rates were similar across groups by week 24.
Improvements in pain, fatigue, Psoriatic Arthritis Impact of Disease (PsAID) score, and tender joint count were observed across all treatment groups. The magnitude of weight loss was significantly associated with improvements in these outcomes and in DAPSA, independent of treatment group.
These findings suggest that, in overweight or obese patients with PsA, weight loss itself, regardless of the dietary approach used, may represent an effective adjunctive strategy for reducing residual disease activity.
- Eder L, et al. Dietary interventions in psoriatic arthritis (DIPSA): a randomised controlled clinical trial. OP070, EULAR 2026, 3–6 June, London, United Kingdom.
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In the BE-BOLD-trial (NCT06624228), the first randomised head-to-head comparison of 2 widely used biologics in psoriatic arthritis (PsA), bimekizumab achieved a significantly higher American College of Rheumatology 50% (ACR50) response than risankizumab at week 16. This advantage was maintained for an additional 8 weeks of treatment in this phase 3b study.
Direct comparative evidence remains scarce in PsA, a gap that prompted this study, as Prof. Joseph Merola (University of Texas Southwestern, TX, USA) pointed out [1]. Risankizumab blocks interleukin (IL)-23, whereas bimekizumab inhibits both IL-17A and IL-17F. Both pro-inflammatory cytokines play a central role in disease activity.
A total of 553 patients were randomised, and approximately 90% completed the study. Around 1 in 5 had shown an inadequate response to tumour necrosis factor (TNF) inhibitors. Because only about 11% of participants (60 of 553) had mild-to-moderate psoriasis at baseline, most received the PsA dosing regimen of bimekizumab (160 mg every 4 weeks) rather than the higher psoriasis regimen (320 mg every 4 weeks through week 16, then every 8 weeks).
The primary endpoint was ACR50, defined as at least a 50% improvement according to the American College of Rheumatology response criteria. “ACR50 represents a very meaningful endpoint in PsA,” Prof. Merola emphasised.
Baseline characteristics were well balanced between the treatment groups; only about a 11% of patients had moderate-to-severe psoriasis (29 of 277 receiving bimekizumab and 31 of 276 receiving risankizumab). At week 16, 49.1% of patients receiving bimekizumab reached ACR50 compared with 38.0% of those receiving risankizumab (P=0.0058), and the separation between the treatment arms was maintained through week 24.
Secondary endpoints, including minimal disease activity, numerically favoured bimekizumab but did not reach statistical significance.
Prof. Merola characterised the safety profile as “reassuring and free of new signals,” noting that the comparison produced what he termed “a welcome lack of surprises.” Overall safety findings were broadly comparable between the 2 agents, with 1 expected difference: Candida infections occurred more frequently with bimekizumab, consistent with its mechanism of action, although cases were mild to moderate. The trial is ongoing, and Prof. Merola indicated that additional data will be reported.
These findings position dual IL-17A/F inhibition with bimekizumab ahead of IL-23 blockade with risankizumab for achieving ACR50 in patients with PsA over 24 weeks, at the cost of a predictable and manageable increase in mild-to-moderate Candida infections.
- Merola J, et al. Bimekizumab efficacy & safety versus risankizumab in patients with active psoriatic arthritis: 16-week results from a head-to-head, multicentre, randomised, phase 3b study (BE BOLD) LB0001, EULAR 2026, 3–6 June, London, United Kingdom.
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A novel agent designed to shift macrophages towards an anti-inflammatory phenotype maintained its therapeutic effect through 6 months. The benefit appeared most pronounced in older patients with osteoarthritis (OA), suggesting a potential link with immune ageing.
As Prof. Philip G. Conaghan (University of Leeds, United Kingdom) explained, allocetra is an off-the-shelf, cost-effective, apoptotic cell therapy administered via intra-articular injection [1]. The therapeutic rationale is based on reprogramming macrophages towards a more anti-inflammatory phenotype. In a phase 1/2a randomised study, 134 patients with symptomatic moderate-to-severe knee OA received 3 intra-articular injections of allocetra at weeks 0, 14, and 28. The injections were generally well tolerated. Local adverse events, including knee pain or discomfort, occurred in 73% of patients receiving allocetra and 79% of those receiving placebo, while knee swelling and reduced range of motion occurred in 79% and 33% of patients receiving placebo, respectively. These events were mostly mild to moderate and transient.
At 6 months, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores improved numerically with allocetra compared with placebo in the modified intention-to-treat (mITT) population (−21.8 vs −20.8; P=0.79). A statistically significant benefit was observed in patients aged ≥64 years (−26.6 vs −11.1; P=0.01). This age-related treatment effect was observed across other efficacy measures, including WOMAC pain and Outcome Measures in Rheumatology (OMERACT).
The investigators suggested that the treatment target may be linked to immunosenescence and immune ageing, indicating that the observed efficacy is associated with age-related changes in the immune system.
“This is a target that is likely related to immunosenescence. This is hopefully opening a new door to treatment pathways,” Prof. Conaghan concluded. A phase 2b trial is currently underway.
- Conaghan Ph. Durable Efficacy at 6 Months Using an Innovative Intra-Articular Apoptotic Cell Therapy in Knee Osteoarthritis: Data from a Phase IIA RCT. OP060, EULAR 2026, 3–6 June, London, United Kingdom.
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The neonatal Fc receptor (FcRn) blocker nipocalimab, already approved for myasthenia gravis, showed promising results in a proof-of-concept phase 2 trial in systemic lupus erythematosus (SLE). By lowering immunoglobulin G (IgG) levels, the drug aims to reduce the pathogenetic autoantibodies that drive the disease.
IgG antibodies contribute to inflammation and tissue damage through direct binding to cellular targets and immune activation following tissue deposition of circulating immune complexes. As explained by Dr Richard Furie (Northwell Health, NY, USA), the rationale for using nipocalimab is that reducing circulating IgG levels should decrease these pathogenic autoantibodies, mirroring the drug’s mechanism of action in myasthenia gravis, for which nipocalimab was approved last year [1].
A phase 2 study randomised 221 patients in a 1:1:1 ratio to receive placebo or nipocalimab at 5 mg/kg or 15 mg/kg, administered every 2 weeks. Participants had relatively long-standing disease and high disease activity despite standard therapy. Treatment continued for 52 weeks, with Systemic Lupus Erythematosus Responder Index-4 (SRI-4) composite response as the primary endpoint.
The study demonstrated clear efficacy. SRI-4 responses were achieved by 54% and 52% of patients receiving the high and low nipocalimab doses, respectively. Although a pronounced placebo response was observed, with 40% of placebo-treated patients achieving SRI-4, the difference between placebo and the high-dose group was statistically significant. Efficacy was also evaluated in 3 prespecified biomarker-defined populations based on nipocalimab’s mechanism of action.
A subgroup of patients with particularly high autoantibody signatures appeared to derive the greatest benefit, with SRI-4 response rates of 76% and 66% in the high- and low-dose groups, respectively, compared with 11% in the placebo group, although this subgroup represented only 15% of the study population. Achievement of lupus low disease activity state (LLDAS) was likewise influenced by biomarker status: at week 52, 38% of patients receiving high-dose therapy achieved LLDAS, compared with 54% in the high-autoantibody subgroup. Both autoantibody levels and circulating immune complexes decreased throughout the treatment period.
The safety profile was reassuring. Infection rates were comparable across the treatment groups, with no unexpected safety findings. In the highest-dose group, IgG concentrations decreased to below 3 g/L in some patients; however, Dr Furie reported that none of these participants experienced serious adverse events.
A phase 3 trial is now underway to confirm these early findings.
- Furie R, et al. Nipocalimab in SLE: First-in-class efficacy and safety results demonstrating proof of concept for FcRn blockade from the phase 2 JASMINE-SLE study. LB0007, EULAR 2026, 3–6 June, London, United Kingdom.
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Current targeted treatment options for polymyalgia rheumatica (PMR) are limited, raising the question of whether an oral Janus kinase (JAK) inhibitor could be effective in this indication. Phase 3 data suggest that baricitinib may represent such an option.
“Knowing all the adverse effects of glucocorticosteroids (GCs), we have a medical need for a GC-free remission in PMR,” said Prof. Helga Lechner-Radner (Medical University Vienna, Austria) [1]. Oral JAK inhibitors may offer a novel therapeutic option, especially in early PMR. To investigate this, a phase 3 trial enrolled 46 patients with very early disease, defined as symptom duration of 3 weeks or less, from centres in Austria, Italy, and Czechia. Patients were randomised 1:1 to receive baricitinib or placebo, while all underwent GC taper, with glucocorticoids reduced to 0 over the first 11 weeks but permitted to be continued or restarted if needed for symptom control.
The study consisted of 3 phases. The first lasted 16 weeks, with GC-free remission at week 16 as the primary endpoint. At week 16, patients in the placebo group crossed over to baricitinib for an additional 12 weeks, while patients originally assigned to baricitinib continued treatment. At week 28, all patients were re-randomised to continue baricitinib 4 mg, step down to 2 mg, or discontinue treatment, with a final assessment at week 44.
GC-free remission at week 16 was achieved by 65% of patients receiving baricitinib compared with 17% receiving placebo (P<0.01). As Prof. Lechner-Radner noted, a highly statistically significant separation between the groups was already evident by week 12. Following the crossover, the former placebo group also reached a GC-free remission rate of 65%. Relapse-free survival curves separated as early as week 9, favouring baricitinib, which was also associated with a lower cumulative GC dose and greater improvements in patient-reported pain and global assessment.
During the withdrawal phase, symptoms recurred in patients who discontinued baricitinib, suggesting that treatment benefits were not sustained after withdrawal. Among patients who continued baricitinib, only 7% lost GC-free remission, although this numerical difference did not reach statistical significance.
These findings suggest that baricitinib may provide an effective oral alternative to biologic therapy in PMR. However, the loss of benefit after treatment discontinuation indicates that continued treatment may be required to maintain disease control.
- Lechner-Radner H, et al. Baricitinib for remission induction and glucocorticoid sparing in new-onset polymyalgia rheumatica (JAK-Spare) – a Phase III randomized controlled trial. LB0005, EULAR 2026, 3–6 June, London, United Kingdom.
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In the phase 3 REPLENISH (NCT05767034) trial, both doses of the interleukin (IL)-17A inhibitor secukinumab approximately doubled sustained remission rates compared with placebo in patients with recently relapsed polymyalgia rheumatica (PMR) while significantly reducing cumulative glucocorticoid exposure. REPLENISH is the largest randomised controlled trial conducted in PMR to date and met its primary and all secondary endpoints.
“Polymyalgia rheumatica is one of the most common immune-mediated diseases in the elderly. There is a medical need for new treatment options for these patients,” said Prof. Christian Dejaco (Medical University of Graz, Austria) [1]. At present, glucocorticoids remain the mainstay of treatment despite frequent relapses and well-recognised adverse effects. Circulating T helper 17 (Th17) cells and serum IL-17A levels are elevated in patients with PMR compared with healthy controls, and phase 2 data provided the rationale for testing the anti–IL-17A antibody secukinumab.
The randomised, double-blind, placebo-controlled trial enrolled 381 patients aged 50 years or older with recently relapsed PMR, who were randomised in a 1:1:1 ratio to secukinumab 300 mg, secukinumab 150 mg, or placebo, each combined with a 24-week open-label prednisone taper. The primary endpoint was sustained remission at week 52. Approximately 80% of patients receiving secukinumab completed the study treatment, compared with 68% of patients receiving placebo.
Both secukinumab doses were superior to placebo. Sustained remission was achieved by 41.2% of patients receiving 300 mg and 40.6% receiving 150 mg, compared with 20.4% receiving placebo (both comparisons P<0.001). Complete sustained remission, which additionally required normalisation of acute phase reactions, showed a similar pattern (28.2% and 24.5% vs 4.7%, respectively; both comparisons P<0.001).
Moreover, secukinumab demonstrated a clear glucocorticoid-sparing effect. The adjusted mean annual cumulative glucocorticoid dose was reduced to 1603.7 mg and 1683.2 mg with secukinumab 300 mg and 150 mg, respectively, compared with 2093.0 mg with placebo (P<0.001 for the 300 mg dose and P<0.01 for the 150 mg dose). Glucocorticoid toxicity index scores were correspondingly lower. Secukinumab also approximately halved the risk of requiring escape or rescue therapy, extending median time to first rescue treatment to 337 and 282 days, respectively, compared with 157 days with placebo.
Adverse and serious adverse events were broadly comparable across treatment arms, with no new safety signals.
“These data suggest that IL-17A inhibition with secukinumab is a promising novel treatment option with a glucocorticoid-sparing effect in patients with recently-relapsed PMR,” Prof. Dejaco concluded.
- Dejaco C, et al. Secukinumab in polymyalgia rheumatica: Results of the phase 3 REPLENISH trial. OP0116, European Congress of Rheumatology EULAR 2026, 3–6 June 2026,
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In the first clinical trial for sonelokimab in axial spondyloarthritis (axSpA), most patients achieved at least a 40% improvement in symptoms within the first month, with responses sustained through week 12. These phase 2 findings were accompanied by measurable reductions in inflammatory joint lesions on imaging.
“One important aspect of axSpA is inflammation, and it has an impact on physical function. We can even visualise osteoblast activity in the disease,” explained Prof. Xenofon Baraliakos (Ruhr University, Germany) [1]. Sonelokimab is a nanobody, essentially a monoclonal antibody stripped to its functional core, with a molecular weight of approximately 40 kDa compared with 150 kDa for a conventional antibody. According to Prof. Baraliakos, this smaller size allows the agent to penetrate deep tissues more readily. The current phase 2 study provided the first evidence of robust multidomain efficacy with this approach.
The open-label, single-arm study enrolled 26 patients with typical characteristics of axSpA. All patients had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4 despite treatment with non-steroidal anti-inflammatory drugs (NSAIDs) and had evidence of active disease on MRI and PET scans. Sonelokimab was administered by subcutaneous injection every 2 weeks over an 8-week treatment period. Despite the open-label design, the response rates were notable: more than 80% of patients achieved both Assessment of SpondyloArthritis international Society (ASAS) 40 and ASAS20 responses. Specifically, 77% achieved an ASAS40 response at week 4, increasing to 81% at week 12, with improvements observed across all assessed disease domains.
“To me, the most impressive result was that more than 50% achieved ASAS partial remission after only 12 weeks, despite the caveat of the open-label design,” commented Prof. Baraliakos. Patient-reported symptoms and physical function also improved significantly.
The imaging findings supported the clinical outcomes. Both MRI and PET demonstrated marked, statistically significant reductions in inflammatory lesions, including a significant decline in active osteoblast signal. The inhibition of bone remodelling activity suggests a rapid disease-modifying effect of sonelokimab within affected joints.
The treatment was well tolerated, with no new safety signals identified.
These first clinical data in axSpA suggest that the compact nanobody format of sonelokimab may translate to rapid, high-level ASAS responses and objective improvements on imaging. However, these findings require confirmation in controlled trials.
- Baraliakos X, et al. Impact of sonelokimab, a novel IL-17A/F-inhibiting nanobody, on clinical and imaging outcomes in axial spondyloarthritis: first results of a phase 2 study supported by 18F-NaF PET imaging and MRI. LB0002, EULAR 2026, 3–6 June, London, United Kingdom.
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Compared to tacrolimus, obinutuzumab improved rates of complete and partial remission in patients with primary membranous nephropathy, while demonstrating comparable infection rates between the 2 treatment regimens.
Prof. Fernando Custodio Fervenza (Mayo Clinic, MN, USA) presented results from MAJESTY (NCT04629248), a phase 3, randomised, open-label, multicentre study comparing obinutuzumab with tacrolimus [1]. Patients were eligible if they had biopsy-confirmed membranous nephropathy, a 24-hour urine protein-to-creatinine ratio (UPCR) ≥5 g/g for 3 months or ≥4 g/g for 6 months despite receiving the best available therapy, and an estimated glomerular filtration rate (eGFR) ≥40 mL/min/1.73 m2. Patients were randomised 1:1 to receive obinutuzumab 1 g infusions at weeks 0, 2, 24, and 26, or to tacrolimus through week 60. The primary endpoint was complete remission at week 104, defined as UPCR ≤0.3 g/g with stable eGFR (no more than a 15% decline from baseline). A total of 142 patients were randomised.
The MAJESTY trial met its primary endpoint, with more patients receiving obinutuzumab than tacrolimus achieving complete remission at week 104. Furthermore, a greater proportion of patients receiving obinutuzumab achieved a proteinuric response at week 104. Obinutuzumab also resulted in higher rates of overall remission (complete or partial) at week 104 (51% vs 13%) and of complete remission at week 76 (36% vs 9%) compared with tacrolimus. Infections occurred in 61% of patients receiving obinutuzumab and 57% of those receiving tacrolimus, while serious infections occurred in 6% of patients in each group. Infusion-related reactions were reported in 38% of patients receiving obinutuzumab.
“In conclusion, obinutuzumab demonstrated superiority over tacrolimus in achieving complete remission at week 104,” concluded Prof. Fervenza. “Obinutuzumab also improved overall remission at week 104 and complete response at week 76, and no new safety signals were identified.”
- Fervenza FC, et al. Efficacy and safety of obinutuzumab compared with tacrolimus in primary membranous nephropathy: Topline results of the phase III MAJESTY trial. ERA 2026, 3–6 June. Glasgow, Scotland.
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