What We're Looking Forward to in Rheumatology in H2 2026

The second half of 2026 arrives with one of the most consequential regulatory and clinical calendars rheumatology has seen in years — and unlike many recent half-years defined primarily by conference readouts, H2 2026 carries genuine first-in-disease potential across multiple conditions simultaneously. The most closely watched near-term decision is tildrakizumab's October 29 PDUFA for psoriatic arthritis (PsA), which will land into a market already processing bimekizumab's BE BOLD superiority data over risankizumab and a freshly approved competitor in deucravacitinib — making it the most crowded and actively contested approval environment PsA has seen in a single calendar year.

Beyond PsA, the FDA's review of obinutuzumab's supplemental BLA for broader SLE — supported by the strongest phase 3 lupus dataset in years — is tracking toward a potential Q1 2027 decision, while ianalumab's anticipated regulatory submission for Sjögren disease would open review on what could become the first approved targeted therapy for a condition that has never had one.

The pipeline pressure extends beyond approvals into trial readouts that could reshape practice across multiple disease areas. Full BE BOLD data for bimekizumab vs risankizumab in PsA are expected at the American College of Rheumatology Convergence in November, where they will land alongside potential izokibep durability updates ahead of a planned NDA submission and early zasocitinib phase 3 data that will begin to define the competitive ceiling for TYK2 inhibition in psoriatic disease. In axial disease, upadacitinib's anticipated GCA regulatory submission — now backed by 2-year SELECT-GCA durability data from EULAR — could deliver the first oral glucocorticoid-sparing option for a population in which the cumulative toxicity of corticosteroid exposure is a defining treatment burden. Meanwhile, the obexelimab INDIGO program in IgG4-related disease, sonelokimab's advance into phase 3 planning in axSpA, and evolving CAR-T data in systemic sclerosis represent a tier of pipeline developments that may not carry near-term PDUFA dates but are actively reshaping how the field thinks about disease modification in conditions long considered beyond the reach of precision therapy.

With lupus, PsA, axSpA, Sjögren disease, IgG4-RD, and systemic sclerosis all carrying meaningful data or decisions in the second half, H2 2026 may be remembered as a period when rheumatology's accelerating pipeline finally arrived across the board at once. Here is a preview of the key decisions, data readouts, and guideline updates to watch, with links to RheumatologyLive coverage.

FDA Decision on Tildrakizumab (Ilumya) for Psoriatic Arthritis — PDUFA October 29, 2026

The FDA is reviewing tildrakizumab (Ilumya; Sun Pharma) for a new indication in active psoriatic arthritis, with a PDUFA date of October 29, 2026. If approved, tildrakizumab would become the third IL-23 p19 inhibitor indicated for PsA — joining risankizumab and guselkumab — and the only HCP-administered IL-23 biologic in this class, with quarterly maintenance dosing Sun Pharma has positioned as a potential differentiator. The application arrives in a PsA biologic market already processing bimekizumab's BE BOLD superiority data over risankizumab, which is likely to raise the competitive bar for new IL-23 entrants and intensify scrutiny of how mechanistic class membership translates to clinical performance.

Obinutuzumab (Gazyva) sBLA Review for SLE — Decision Expected Q1 2027

The FDA's review of obinutuzumab's supplemental BLA for SLE — accepted in April 2026 following the ALLEGORY phase 3 data showing 76.7% SRI-4 response vs 53.5% with placebo at 52 weeks (P <.001) — is expected to run through late 2026, with a potential decision in Q1 2027 under a standard 10-month review timeline. If approved, obinutuzumab would be the first anti-CD20 therapy approved for the broader SLE population, extending beyond its existing lupus nephritis indication, and one of only a small number of new mechanisms approved for SLE in the past 2 decades.

Related coverage: ALLEGORY: Obinutuzumab Demonstrates Superiority Over Placebo in SLE

Expected FDA Submission and Decision on Ianalumab for Sjögren Disease

Novartis has indicated plans to submit a regulatory application for ianalumab in Sjögren disease, with the filing expected based on its H1 2026 guidance and a potential PDUFA decision in late 2026 or early 2027. The Breakthrough Therapy designation accelerates review for what would be the first FDA-approved targeted therapy ever for the condition, supported by consistent efficacy and safety signals across both NEPTUNUS phase 3 trials across multiple physician- and patient-reported outcome domains. Sjögren disease affects an estimated 1 to 4 million Americans, predominantly women, with no approved disease-modifying treatment — making ianalumab's regulatory timeline one of the most consequential in rheumatology.

Expected FDA Submission on Upadacitinib for Giant Cell Arteritis

AbbVie is expected to submit a supplemental NDA for upadacitinib in giant cell arteritis based on the SELECT-GCA phase 3 program, with 2-year durability data now in hand from EULAR 2026. GCA has only 1 approved glucocorticoid-sparing agent — tocilizumab — and upadacitinib would be the first oral option for the indication, removing the infusion burden in a predominantly elderly population for whom regular clinical visits carry meaningful practical barriers. The 2-year SELECT-GCA data add subgroup differentiation by disease onset type that could inform labeling discussions with the FDA.

BE BOLD Full Data Presentation — Expected ACR Convergence 2026

Full data from the phase 3b BE BOLD trial — which showed bimekizumab superiority over risankizumab in ACR50 at week 16 in active PsA (49.1% vs 38.4%) — are expected to be presented at ACR Convergence 2026 in November, where they will likely be among the most discussed datasets in the PsA space. The topline release at EULAR established the headline joint result; full publication will add secondary endpoints including skin, enthesitis, dactylitis, and axial outcomes, safety data, and subgroup analyses that will be critical for clinicians and payers constructing the comparative evidence base. The dataset will also land in a market that by then will have processed the tildrakizumab PsA approval decision, making the IL-17A/F vs IL-23 competitive conversation especially timely.

Related coverage: BE BOLD: Bimekizumab Delivers First Head-to-Head Superiority Data in PsA, With Iain McInnes, MD, PhD

Izokibep NDA Submission in PsA

With phase 2b/3 primary and 52-week durability data now in hand from EULAR 2026, Acelyrin is expected to move toward an NDA submission for izokibep in psoriatic arthritis in H2 2026. If filed and accepted, izokibep would be the first Affibody-based therapy to enter FDA review in rheumatology and would offer a mechanistically and structurally distinct IL-17A inhibitor option — approximately one-tenth the molecular weight of a conventional antibody — with potential tissue-penetration advantages in entheseal and synovial compartments. The entry of a novel IL-17A inhibitor into the PsA regulatory pipeline comes at a moment when the class is receiving renewed attention following BE BOLD.

Zasocitinib Phase 3 PsA Data

Zasocitinib, a second oral TYK2 inhibitor now in phase 3 trials for psoriatic arthritis, is expected to generate readout data in H2 2026 or early 2027. Phase 2b results showed ACR20 responses of approximately 54% at week 12 vs 29% with placebo (P =.002), establishing proof of concept for TYK2 inhibition in PsA alongside deucravacitinib's now-approved program. As the second TYK2 inhibitor to enter late-stage development in PsA, zasocitinib's phase 3 results will begin to define whether the class represents a durable mechanistic advance or whether differentiation between agents will hinge on safety, dosing, or label nuance.

ACR Convergence 2026 — November, in Orlando, Florida

ACR Convergence 2026 will be the year's most important rheumatology data forum and is expected to serve as the landing pad for several of the half-year's most anticipated datasets. Full BE BOLD data, longer-term SELECT-GCA analyses, updated izokibep PsA data ahead of a regulatory submission, any obexelimab INDIGO follow-up or publication data, and early signals from the growing GLP-1 and rheumatology intersection — across RA, PsA, and gout — are all plausible agenda items. The meeting will also provide the first major opportunity to contextualize the tildrakizumab PsA approval (if granted in October) within a now-crowded IL-23 inhibitor class, and to process the competitive implications of BE BOLD for the field more broadly. RheumatologyLive will provide live expert interview coverage and written writeups from the meeting.