First Half 2026 Rheumatology Recap

The first half of 2026 was among the most consequential half-years in rheumatology in recent memory, defined by a first-in-class oral approval, landmark head-to-head data, a major EULAR readout season, 2 significant guideline updates, and a string of regulatory filings that set up an eventful second half. The most significant regulatory story of the half was the March approval of deucravacitinib for psoriatic arthritis (PsA) — the first TYK2 inhibitor indicated for PsA, expanding a class already established in plaque psoriasis.

At the European Alliance of Associations for Rheumatology (EULAR) 2026 annual congress in London in June, bimekizumab delivered the first head-to-head superiority result for a joint endpoint in PsA, beating risankizumab in BE BOLD. In systemic lupus erythematosus (SLE), obinutuzumab's ALLEGORY data — published simultaneously in the New England Journal of Medicine and presented at SLEuro in March — showed a 23-point separation from placebo in SRI-4 response, setting up what may be the most significant lupus approval decision on the near-term horizon. Two major ACR guideline updates reshaped clinical practice in axSpA and juvenile idiopathic arthritis, and the regulatory pipeline for the second half is loaded.

Here's a concise overview of the key rheumatology stories from H1 2026.

FDA Approves Deucravacitinib for Psoriatic Arthritis

Deucravacitinib (Sotyktu; Bristol Myers Squibb), a selective oral TYK2 inhibitor that modulates IL-23 and IL-12 signaling while avoiding broader JAK pathway inhibition, received FDA approval on March 6, 2026, for adults with active psoriatic arthritis — the first TYK2 inhibitor approved for PsA, expanding on the drug's September 2022 indication for moderate-to-severe plaque psoriasis. The phase 3 POETYK PsA-1 and PsA-2 trials demonstrated statistically significant improvements in ACR20 response at week 16 vs placebo, along with improvements in skin, functional, and quality-of-life measures. The approval adds a novel oral mechanism to a PsA landscape previously served by JAK inhibitors, IL-17 inhibitors, and IL-23 inhibitors.

Related coverage: Deucravacitinib, Zasocitinib Validate TYK2 Inhibition in PsA, With Philip Mease, MD

FDA Approves Anifrolumab Subcutaneous Autoinjector for SLE

The FDA approved a once-weekly subcutaneous autoinjector formulation of anifrolumab-fnia (Saphnelo Pen; AstraZeneca) on April 27, 2026, enabling self-administration for adults with moderate to severe SLE receiving standard therapy, based on the phase 3 TULIP-SC trial in which 29% of patients achieved DORIS remission and 40.1% attained low-level disease activity. The new formulation expands on the existing intravenous route for the type I interferon receptor antagonist, removing the scheduling burden of regular infusion visits for a disease requiring sustained long-term management. The subcutaneous route may improve adherence and reduce indirect care costs across a predominantly working-age patient population.

Related coverage: Joint Ventures: Nipocalimab Advances and a Deucravacitinib Decision Looms

Guselkumab Becomes First IL-23 Inhibitor With Structural Joint Damage Inhibition Claim in PsA

The FDA approved a supplemental label update for guselkumab (Tremfya; Johnson & Johnson) on May 28, 2026, adding evidence of structural joint damage inhibition — making it the first and only IL-23 inhibitor with that claim in its US PsA prescribing information, based on the phase 3b APEX trial. Structural damage in PsA manifests radiographically as erosions and joint space narrowing; IL-17 inhibitors have long held this claim, and the updated guselkumab label closes a competitive gap that had historically disadvantaged the IL-23 class in prescribing conversations with patients at risk for radiographic progression.

Related coverage: Understanding Guselkumab's New Joint Damage Label for PsA, With Philip Mease, MD

ALLEGORY: Obinutuzumab Demonstrates Superiority Over Placebo Across All Key Endpoints in SLE

Full phase 3 ALLEGORY data published March 6 in the New England Journal of Medicine showed that obinutuzumab achieved SRI-4 response in 76.7% of patients vs 53.5% with placebo at week 52 (adjusted difference 23.1%; 95% CI, 12.5 to 33.6; P <.001), with superiority demonstrated across all 5 prespecified key secondary endpoints. Obinutuzumab is a type II anti-CD20 monoclonal antibody already approved for active lupus nephritis; ALLEGORY evaluated it in the broader SLE population — a substantially larger and more heterogeneous group — where no new mechanism has been approved in years. The FDA has accepted the supplemental BLA, with a review period that may extend into early 2027.

Related coverage: FDA Accepts sBLA for Obinutuzumab in SLE Based on Phase 3 ALLEGORY Data

BE BOLD: Bimekizumab Bests Risankizumab for ACR50 Joint Outcomes in PsA

The phase 3b BE BOLD trial, presented at EULAR 2026 in June, delivered the first head-to-head superiority result for a joint-focused endpoint in PsA: 49.1% of patients receiving bimekizumab achieved ACR50 at week 16 vs 38.4% receiving risankizumab, a statistically significant difference. BE BOLD is the first study to directly test an IL-17A/F inhibitor against an IL-23 inhibitor in active PsA, with UCB arguing that bimekizumab's dual blockade of IL-17A and IL-17F — reaching tissues via sources independent of the IL-23 pathway — provides a mechanism advantage for joint disease that the EULAR data now support clinically. Full data are expected to be presented at a future medical meeting.

Related coverage: BE BOLD: Bimekizumab Superiority Over Risankizumab in PsA Joints

Izokibep Sustains PsA Efficacy at 52 Weeks, With Philip Mease, MD

Phase 2b/3 data presented at EULAR 2026 showed that izokibep — an Affibody molecule targeting IL-17A that is approximately one-tenth the size of a conventional monoclonal antibody — maintained ACR50, PASI90/100, and minimal disease activity responses through 52 weeks in adults with active PsA. The agent met its primary ACR50 endpoint at week 16 with high statistical significance in the earlier phase 2b/3 readout; the year-long durability data build on a profile that includes subcutaneous administration and a tissue-penetrating pharmacokinetic advantage designed to reach entheseal and synovial compartments more effectively. A regulatory submission is in preparation.

Prior Relapse Predicts Faster Flare After Stopping Upadacitinib in GCA

Two-year data from the phase 3 SELECT-GCA trial, presented at EULAR 2026, showed that upadacitinib maintained disease remission in giant cell arteritis over the longer term, with a subgroup breakdown differentiating responses in new-onset vs relapsing disease. GCA currently has only one approved glucocorticoid-sparing agent — tocilizumab — and glucocorticoid toxicity carries meaningful cumulative risk in a predominantly older patient population; sustained remission with upadacitinib would offer clinicians a second targeted option with a different mechanism and oral administration. A regulatory submission for GCA is anticipated.

INDIGO Trial Establishes Obexelimab as First Positive Phase 3 Therapy in IgG4-Related Disease

Phase 3 INDIGO trial data presented at EULAR 2026 by Emanuel Della Torre, MD, of IRCCS San Raffaele Hospital, established proof of concept for B-cell inhibition in IgG4-related disease — the largest randomized controlled trial conducted in IgG4-RD to date. Obexelimab targets CD19 and FcγRIIb on B cells to suppress their activity without depleting them, contrasting with rituximab's depletion mechanism and offering potential advantages including subcutaneous administration and preservation of immunologic memory. The INDIGO results position obexelimab as the first candidate with a completed phase 3 program in a disease with no FDA-approved therapies.

Sonelokimab S-OLARIS: First-in-Disease Phase 2 Data in AxSpA Show Clinical and Imaging Responses

Sonelokimab, a Nanobody that inhibits both IL-17A and IL-17F, produced rapid and substantial clinical responses — including significant improvements in BASDAI and ASDAS scores — alongside significant reductions in sacroiliac joint inflammation and osteoblastic activity on imaging in the phase 2 S-OLARIS proof-of-concept trial in active axSpA, presented as a late-breaking oral at EULAR 2026 by EULAR President Xenofon Baraliakos, MD, PhD. The imaging findings are particularly notable: simultaneous effects on both inflammatory and structural bone-remodeling endpoints in a single phase 2 trial are uncommon, and the osteoblastic signal may have implications for understanding how dual IL-17A/F inhibition differs from IL-17A-only blockade in axial disease. Phase 3 development planning is anticipated.

CAR-T and Early Diagnosis Reshape the Systemic Sclerosis Landscape at EULAR 2026

EULAR 2026 marked a meaningful reorientation in the systemic sclerosis field, with data supporting a conceptual shift from managing fibrotic sequelae toward targeting the autoantibody-driven mechanisms believed to initiate disease — underpinned by emerging evidence that antitopoisomerase I and anti-RNA polymerase III antibodies may actively drive disease through mitochondrial damage rather than simply reflecting it. Novel CAR-T approaches targeting both CD19 and BCMA generated significant discussion as potential paradigm-shifting interventions, while an Italian VEDOSS study conducted with the University of Leeds identified three early disease subsets with distinct progression trajectories — including one characterized by elevated antitopoisomerase I antibodies where nearly 50% of patients progressed to established disease. The EULAR program signaled a field moving toward earlier intervention and cellular therapy with new urgency.

2026 ACR/SAA/SPARTAN AxSpA Guideline Elevates JAK Inhibitors, Adds Juvenile Recommendations

The 2026 ACR/SAA/SPARTAN axial spondyloarthritis guideline update introduced two major shifts from the prior 2019 guidance: elevation of JAK inhibitors (tofacitinib, upadacitinib) from conditional to strong recommendation in the second-line setting for adults, and the first dedicated guideline section for juvenile axSpA. Notably, IL-23 inhibitors received a strong recommendation against use in both adults and children with axSpA and axial PsA, reflecting persistent trial evidence of inadequate efficacy in predominantly axial disease. New guidance on nociplastic pain — strongly discouraging opioids and conditionally recommending cognitive behavioral therapy and SNRIs/SSRIs in adults — addresses a complication of axSpA that has historically lacked formal management recommendations.

2026 ACR JIA Guidelines: Early Biologics, Reversal on Methotrexate, Mental Health Screening

The 2026 ACR juvenile idiopathic arthritis guideline update urges earlier initiation of biologic therapy, reverses previous subcutaneous methotrexate preference in favor of oral administration in select populations, adds formal mental health screening recommendations, and reshapes tapering and monitoring frameworks across JIA subtypes. The early biologics push reflects accumulating evidence that earlier intervention modifies disease course and reduces damage accrual, while the methotrexate reversal addresses tolerability data showing comparable efficacy with improved adherence profiles on oral dosing in certain patients.

Ianalumab Receives FDA Breakthrough Therapy Designation for Sjögren Disease

The FDA granted Breakthrough Therapy designation to ianalumab (Novartis) for Sjögren disease in January 2026, recognizing it as a potential first targeted therapy for a condition with no currently approved treatments. Ianalumab is a fully human monoclonal antibody that combines B-cell depletion via enhanced antibody-dependent cellular cytotoxicity with blockade of the B-cell activating factor receptor (BAFF-R) — a dual mechanism that may offer advantages over earlier B-cell–directed approaches targeting only one pathway. Novartis announced plans to submit regulatory applications globally in early 2026, with a potential US decision to follow.

Related coverage: Breakthrough Therapy Ianalumab Nears FDA Submission for Sjögren, With Thomas Grader-Beck, MD