Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

Victoria Johnson

Rheumatology in 2025 was marked by an unusually dense stretch of regulatory decisions and late-stage data that expanded treatment options across autoimmune, inflammatory, and neuromuscular diseases. From rare conditions like IgG4-related disease and myasthenia gravis to high-burden disorders such as rheumatoid arthritis, lupus nephritis, psoriatic disease, and fibromyalgia, the FDA approved multiple first-in-class or indication-expanding therapies that addressed long-standing gaps in care. Several of these decisions reflected a broader shift toward targeted immune modulation, non–immune-suppressive approaches, and mechanism-driven innovation.

Beyond approvals, pivotal trial readouts in 2025 reshaped expectations for emerging agents across rheumatology. Phase 2 and 3 data supported durable efficacy for novel biologics and oral therapies in rheumatoid arthritis and psoriatic arthritis, reinforced the renal benefits of B-cell depletion in lupus nephritis, and strengthened the evidence base behind newly approved fibromyalgia treatments. 

At the same time, feature reporting and expert discussions highlighted the limits of pharmacology alone and the growing importance of integrated, multidisciplinary care. Clinicians emphasized earlier diagnosis, cross-specialty collaboration, and realistic expectations for new therapies, particularly in complex, heterogeneous diseases. Taken together, the top rheumatology news of 2025 reflects both meaningful progress and a clearer understanding of where innovation must go next to translate advances into sustained improvements in patient outcomes.

FDA Approves Inebilizumab (Uplizna) as First IgG4-RD Therapy for Adults


The FDA has approved inebilizumab-cdon (Uplizna) as the first treatment for adults with immunoglobulin G4-related disease (IgG4-RD), addressing a significant unmet need in this rare autoimmune condition. This approval offers a new therapeutic option for patients previously reliant on less targeted treatments.​

FDA Approves Upadacitinib, Expanding Treatment for Adults With Giant Cell Arteritis


Upadacitinib has received FDA approval for treating adults with giant cell arteritis, providing a new option for managing this inflammatory vascular disease. This expands the therapeutic arsenal for clinicians dealing with this challenging condition.​

FDA Approves TNX-102 SL, First New Fibromyalgia Therapy in 15 Years

On August 15, the FDA approved TNX-102 SL (Tonmya), the first new fibromyalgia therapy in more than 15 years, offering a novel sublingual, non-opioid approach that targets nonrestorative sleep to improve pain and other core symptoms. Approval was based on the phase 3 RESILIENT trial, where the drug showed significant pain reduction as early as week 1 along with improvements in sleep and fatigue.

FDA Approves Neuroimmune Modulation Therapy for Rheumatoid Arthritis

The FDA has approved SetPoint Medical’s SetPoint System, the first neuroimmune modulation device for rheumatoid arthritis, offering a novel implantable therapy that stimulates the vagus nerve to reduce inflammation without immune suppression. In the pivotal RESET-RA trial, the device significantly improved ACR20 response rates at 12 weeks, with benefits sustained through 12 months and a favorable safety profile.

FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis

On September 29, 2025, the FDA approved guselkumab (Tremfya) for children aged ≥6 years and weighing ≥40 kg with moderate to severe plaque psoriasis or active psoriatic arthritis, making it the first IL-23 inhibitor approved for these pediatric indications. The decision was supported by the phase 3 PROTOSTAR trial, where guselkumab significantly improved skin clearance compared with placebo, and by extrapolated data from adult PsO and PsA studies. This expands guselkumab’s use beyond its prior adult approvals and provides a new treatment option for children with these immune-mediated diseases.

FDA Approves Obinutuzumab for Lupus Nephritis

On October 20, 2025, the FDA approved Genentech’s obinutuzumab (Gazyva) for the treatment of lupus nephritis. The decision was based on positive results from the phase 2 NOBILITY and phase 3 REGENCY studies. In REGENCY, nearly half of the participants (46.4%) on obinutuzumab in combination with standard therapy achieved a complete renal response compared to 33.1% on standard therapy alone, accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, corticosteroid use, and proteinuria.

Rosnilimab Continues Best-in-Disease Profile Responses for Rheumatoid Arthritis

Updated 6-month data from the phase 2b RENOIR trial showed rosnilimab sustained strong efficacy in moderate-to-severe rheumatoid arthritis, with durable responses and deepening disease activity improvements over time. The PD-1–targeting therapy demonstrated efficacy on par with JAK inhibitors but with a favorable safety profile and immune-restorative effects, supporting its potential as a long-term treatment option.

REGENCY: Obinutuzumab Proves Efficacy in Lupus Nephritis


Use of obinutuzumab (Gazya/Gazyvaro) was superior to standard of care therapy alone for achieving a complete renal response in patients with active lupus nephritis, according to results from the phase 3 REGENCY trial.

Phase 3 Deucravacitinib Trial Meets ACR20 End Point in PsA

The phase 3 POETYK PsA-1 trial demonstrated that deucravacitinib significantly improved joint and skin symptoms in adults with active psoriatic arthritis, meeting its primary endpoint with 54.2% of treated patients achieving ACR20 response at week 16 versus 34.1% on placebo. Key secondary endpoints were also met, including significant improvements in skin clearance, physical function, and quality of life measures, alongside evidence of inhibited radiographic progression. The safety profile of deucravacitinib was consistent with previous studies, with no new safety signals identified, supporting its potential as an oral, first-in-class TYK2 inhibitor for psoriatic arthritis management.

Positive Cemdisiran Phase 3 Data Paves Way for Myasthenia Gravis BLA Submission

Regeneron’s cemdisiran met primary and secondary endpoints in the phase 3 NIMBLE trial for generalized myasthenia gravis, showing significant improvements in patient-reported and physician-assessed outcomes over placebo. The siRNA therapy, given quarterly, demonstrated robust efficacy with manageable safety, positioning it for a planned BLA submission in early 2026.

TNX-102 SL Data Supports Recent Fibromyalgia Approval

New phase 3 data from the RESILIENT and RELIEF trials, presented at PAINWEEK 2025, confirmed that TNX-102 SL (Tonmya) significantly reduced pain in fibromyalgia compared with placebo, supporting its recent FDA approval as the first new treatment for the condition in over 15 years. At Week 14 in RESILIENT, patients receiving TNX-102 SL had a mean weekly pain score of 4.1 versus 4.7 with placebo, with all six secondary endpoints also met. The therapy was well-tolerated, with low discontinuation rates and no unexpected safety signals.

Reframing Fibromyalgia Care in 2025: Restricted Impact of TNX-102 SL’s Approval

The FDA approval of TNX-102 SL in August 2025 marked the first new fibromyalgia drug approval in more than 15 years, introducing a sleep-targeted, non-opioid approach aimed at addressing nonrestorative sleep as a core driver of symptoms. Clinicians view the therapy as a meaningful but incremental advance that may benefit selected patients when integrated into multimodal care, rather than a standalone solution for this complex, heterogeneous condition.

Closing the Gap: Collaborating Care to Improve Outcomes in Psoriasis and Psoriatic Arthritis

Experts are calling for earlier, more coordinated detection of psoriatic arthritis, which develops in up to 30% of patients with psoriasis and is often diagnosed years too late. In this 

 feature, leading dermatology and rheumatology voices discuss how routine screening, shared treatment strategies, and cross-specialty collaboration can help close diagnostic gaps and prevent irreversible joint damage.

Articles

Rheumatology in 2025 saw significant advancements with numerous FDA approvals and pivotal trial results, expanding treatment options for autoimmune, inflammatory, and neuromuscular diseases. New therapies addressed unmet needs in conditions like IgG4-related disease, giant cell arteritis, fibromyalgia, and lupus nephritis. The shift towards targeted immune modulation and non-immune-suppressive approaches was evident. Despite these advancements, experts emphasized the importance of integrated, multidisciplinary care and realistic expectations for new therapies, particularly in complex diseases. The year highlighted both progress and the need for continued innovation to improve patient outcomes.

The hreumatology year in review highlights FDA approvals

Rheumatology in 2025: Year in Review

The United States (US) Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for pemvidutide for the treatment of 

metabolic dysfunction-associated steatohepatitis

“The FDA’s Breakthrough Therapy Designation for pemvidutide in MASH reinforces the promise of its clinical profile and potential to address significant unmet needs in this serious, progressive liver disease,” Jerry Durso, President and Chief Executive Officer of Altimmune, said in a statement

. “As I step into the CEO role, this designation represents an important validation for pemvidutide. Phase 2b data support its differentiated profile and the meaningful role it could play in MASH, and potentially other serious liver diseases. With this breakthrough designation and alignment with the FDA on registrational Phase 3 trial parameters, we are laser-focused on strengthening the foundation of Altimmune to advance pemvidutide through late-stage development – guided by our commitment to serve patients and create value for our stakeholders.”

Pemvidutide is a balanced 1:1 glucagon/GLP-1 dual receptor agonist. The FDA granted BTD to the therapy based on 24-week data from the IMPACT Phase 2b trial that demonstrated statistically significant MASH resolution without worsening of fibrosis and early and substantial improvements in liver fat and non-invasive tests (NITs) of fibrosis and hepatic inflammation.

More recently, 48-week data reported by Altimmune in December 2025 demonstrated that treatment with pemvidutide achieved statistically significant improvements across treatment arms in key NITs including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), versus placebo. Of note, these data exhibited continued reductions from week 24 and provide evidence of continued improvement in antifibrotic activity with both treatment doses.

Impact enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2 or F3, with or without diabetes. Participants were randomized in a 1:2:2 ratio to receive weekly subcutaneous pemvidutide at doses of 1.2 mg or 1.8 mg, or placebo, for 48 weeks. The primary efficacy endpoints, assessed at 24 weeks, were MASH resolution without worsening of fibrosis or improvement in fibrosis without worsening of MASH, while secondary endpoints included noninvasive tests of fibrosis and weight loss evaluated at both 24 and 48 weeks.

At 24 weeks, pemvidutide treatment resulted in statistically significant improvements in key noninvasive markers of fibrosis. Mean ELF score reductions from baseline were −0.49 with the 1.2 mg dose and −0.58 with the 1.8 mg dose, compared with a mean increase of +0.16 in the placebo group (

 < .0001 for both doses). Mean liver stiffness measurement (LSM) decreased by −3.04 with 1.2 mg (

 < .001), versus −0.03 with placebo. A composite response of both a ≥0.5 reduction in ELF and a ≥30% reduction in LSM was achieved by 27.8% of participants receiving 1.2 mg and 32.4% receiving 1.8 mg, compared with 3.2% of placebo-treated participants (

Additional analyses showed substantial metabolic and hepatic improvements with pemvidutide. Mean liver fat content was reduced by 45.2% with 1.2 mg and 54.7% with 1.8 mg, compared with 8.2% with placebo (

 < .0001). Mean ALT decreased by −37.8 IU/L and −37.4 IU/L with the 1.2 mg and 1.8 mg doses, respectively, versus −10.3 IU/L with placebo (

 < .0001 for both), while cT1 was reduced by −124 ms and −140 ms versus −21 ms (

 < .0001). Weight loss reached 4.5% and 7.5% with pemvidutide 1.2 mg and 1.8 mg, respectively, compared with 0.2% with placebo (

 < .0001), with no plateau observed at 48 weeks for the 1.8 mg dose. Adverse events leading to treatment discontinuation occurred in 0% and 1.2% of patients receiving pemvidutide 1.2 mg and 1.8 mg, respectively, compared with 3.5% in the placebo group, and no serious or severe treatment-related adverse events were reported.

Altimmune has aligned with the FDA on the parameters for a planned registrational phase 3 trial of pemvidutide for MASH patients with moderate to advanced liver fibrosis evaluating multiple pemvidutide doses over a 52-week treatment period and incorporating biopsy-based endpoints to support a potential accelerated approval and the use of AIM-MASH AI Assist, the first AI pathology tool qualified by the FDA for use in MASH clinical trials.

Altimmune Receives FDA Breakthrough Therapy Designation for Pemvidutide in MASH. News release. Altimmune. January 5, 2026. 

https://www.globenewswire.com/news-release/2026/01/05/3212638/0/en/Altimmune-Receives-FDA-Breakthrough-Therapy-Designation-for-Pemvidutide-in-MASH.html

Altimmune. Altimmune Announces that Pemvidutide Achieved Key Measures of Success at 48 Weeks in IMPACT Phase 2b MASH Trial. December 19, 2025. Accessed December 19, 2025. https://www.globenewswire.com/news-release/2025/12/19/3208385/0/en/Altimmune-Announces-that-Pemvidutide-Achieved-Key-Measures-of-Success-at-48-Weeks-in-IMPACT-Phase-2b-MASH-Trial.html

The FDA has granted Breakthrough Therapy Designation to pemvidutide for treating metabolic dysfunction-associated steatohepatitis (MASH), highlighting its potential to address unmet needs in this progressive liver disease. Pemvidutide, a glucagon/GLP-1 dual receptor agonist, showed significant MASH resolution and improvements in liver fat and fibrosis markers in the Phase 2b trial. The trial involved 212 participants, demonstrating substantial metabolic and hepatic improvements with pemvidutide. Altimmune plans a Phase 3 trial with biopsy-based endpoints to support potential accelerated approval, utilizing the AIM-MASH AI Assist tool.

The designation follows positive phase 2b data and FDA alignment on a phase 3 trial.

Pemvidutide Gets Breakthrough Therapy Designation for MASH

Credit: Cincinnati Children’s Hospital Medical Center

In a recent study, a response to adjunctive cariprazine by week 2 predicted sustained antidepressant benefit in 

, with greater baseline depression linked to greater response.

“This study highlights the importance of early symptom change, dose-response dynamics, and patient-level predictors in shaping response to adjunctive cariprazine,” wrote investigators Jeffrey R. Strawn, MD, and Jeffrey A. Mills, PhD, both from the department of pediatrics at the Cincinnati Children’s Hospital Medical Center.

 approved cariprazine (VRAYLAR) as an adjunctive treatment to antidepressants for MDD, supported by a phase 3 randomized, double-blind, placebo-controlled trial involving 751 participants across the US and Europe.

 Cariprazine is also approved to treat schizophrenia and depressive, acute manic, and mixed episodes associated with bipolar I disorder.

Three years after the FDA decision, methods for predicting which patients will respond to adjunctive cariprazine were still unknown.

 Strawn and Mills conducted a meta-analysis of 2 multicenter, double-blind, placebo-controlled phase 3 trials that compared adjunctive cariprazine 1.5 mg/day, 3 mg/day, and placebo in participants receiving stable antidepressant treatment. Across the 2 studies, there were 1501 participants.

The primary outcome was change in Montgomery–Åsberg Depression Rating Scale (MADRS) scores, and secondary outcomes included Clinical Global Impressions–Improvement (CGI-I) and Hamilton Anxiety Rating Scale (HAM-A) scores. Investigators used Bayesian logarithmic trend models to characterize individual response trajectories and identify predictors of response.

Compared to placebo, adjunctive cariprazine at 1.5 mg/day (

 =.002) significantly improved depressive symptoms. A response by week 2 predicted continued improvement across the 6-week trial.

Greater severity levels of depression at baseline predicted a larger response to adjunctive cariprazine (

 <.001). Investigators observed a greater response in women and those using SSRIs (

The analysis revealed that participants with comorbid anxiety had smaller reductions in MADRS scores (

<.001). Among patients with anxiety, a greater baseline HAM-A score predicted sustained improvement (

 <.001). Greater baseline depression severity was linked to reduced anxiety improvement during adjunctive cariprazine treatment (

 <.001). Only cariprazine 1.5 mg/day, not 3 mg/day, slightly improved HAM-A scores compared to placebo (

“By leveraging a large, rich dataset of individual patient responses across multiple clinical trials and using a Bayesian framework, we move one step closer to understanding not just whether cariprazine works, but for whom, at what dose, and when,” investigators concluded.

A recent phase 3 trial found that adjunctive lumateperone 42 mg led to statistically significant reductions in depressive symptoms and disease severity by day 43 in adults with MDD.

The long-term data followed the FDA approval of Johnson & Johnson’s lumateperone as an adjunctive therapy for MDD in November 2025. Lumateperone, an oral, once-daily atypical antipsychotic, targets 3 neurotransmitters at the same time: serotonin, dopamine, and glutamate. The drug acts as a 5-HT2A antagonist and modulates dopamine by partially agonizing presynaptic D2 receptors and blocking postsynaptic ones.

The trial met its primary endpoint (change from baseline to day 43 in MADRS total score; least squares mean difference [LSMD] versus placebo, −4.5; effect size, −0.56). The trial also met its secondary endpoint, change from baseline to day 43 in the Clinical Global Impressions Scale severity (CGI-S) score (LSMD, −0.5; effect size, −0.51). Participants on lumateperone had significantly improved patient-reported depression compared to those on placebo by day 43 (16-item Quick Inventory of Depressive Symptomatology-Self-Report, total score, SMD, −2.2; effect size, −0.45).

“This is not new from the standpoint of other atypical antipsychotics have been approved by the FDA for this purpose,” said Ned Kalin, editor-in-chief of the American Journal of Psychiatry and psychiatry department chair at the University of Wisconsin, in a podcast.

 “So, we do have other agents in this class of drugs that are already shown and are approved by [the] FDA to help people with depression, but this is another medicine, and it's really helpful for us because it's not identical to the other medications.”

Strawn JR, Mills JA. Trajectories and predictors of depressive and anxiety symptom improvement with adjunctive cariprazine in antidepressant-treated adults with major depression: A Bayesian mega-analysis of two randomized trials. 

Kunzmann K. FDA Approves Cariprazine as Adjunctive Major Depressive Disorder Therapy. HCPLive. Published December 17, 2022. Accessed January 2, 2026. 

https://www.hcplive.com/view/fda-approves-cariprazine-adjunctive-major-depressive-disorder-therapy

Derman C. Adjunctive Lumateperone Significantly Improves MDD Symptoms by Day 43. HCPLive. Published on December 8, 2025. Accessed January 2, 2026. 

https://www.hcplive.com/view/adjunctive-lumateperone-significantly-improves-mdd-symptoms-day-43

A recent study demonstrated that early response to adjunctive cariprazine in major depressive disorder (MDD) predicts sustained antidepressant benefits, with greater baseline depression correlating with a stronger response. The study analyzed data from two phase 3 trials, revealing significant improvements in depressive symptoms with cariprazine compared to placebo. Women and those on SSRIs showed greater responses, while comorbid anxiety was linked to smaller improvements. Additionally, a phase 3 trial of lumateperone showed significant reductions in depressive symptoms, highlighting its potential as an adjunctive therapy for MDD.

A study identified early symptom improvement and greater baseline depression severity as predictors of sustained antidepressant response to adjunctive cariprazine in MDD.

Early Week 2 Response Predicts Sustained Benefit with Adjunct Cariprazine in MDD

Psychiatry Month in Review: December 2025 

 submissions, late-stage clinical trial results, and emerging insights linking mental health to broader medical conditions. December highlighted progress in schizophrenia treatment, with Teva’s TEV- ‘749 entering the regulatory pipeline, and in major depressive disorder (MDD), as adjunctive lumateperone demonstrated rapid symptom improvement.

This month’s review captures these developments alongside a retrospective look at the year, offering clinicians a concise summary of the therapies, trials, and innovations shaping psychiatric practice.

Teva Seeks FDA Approval for Novel Schizophrenia Therapy

Teva Pharmaceuticals Submits NDA on TEV-‘749 for Schizophrenia to the FDA

Teva Pharmaceuticals submitted a New Drug Application (NDA) to the FDA for TEV-‘749, a once-monthly olanzapine extended-release injectable for adults with schizophrenia. TEV-‘749 utilizes Medincell’s SteadyTeq™ technology, a proprietary copolymer system that provides controlled, sustained release of olanzapine.

The phase 3 SOLARIS trial, a 56-week, multinational, multicenter, randomized, double-blind study, evaluated efficacy, safety, and tolerability in patients aged 18 to 64 years. Results showed TEV-‘749 had a consistent efficacy and safety profile compared with oral olanzapine, with high satisfaction reported by patients, nurses, and physicians.

Unlike other long-acting injectables such as risperidone and aripiprazole, TEV- ‘749 introduces a new molecule option. Experts at SUNY Upstate Medical University noted its potential to improve adherence, reduce relapses, and address treatment gaps for the 3.5 million Americans living with schizophrenia, supporting long-term stability.

Adjunctive Lumateperone Shows Strong Phase 3 Results in MDD

Adjunctive Lumateperone Significantly Improves MDD Symptoms by Day 43

A phase 3, randomized, double-blind trial demonstrated that lumateperone 42 mg, when added to antidepressant therapy, significantly improves depressive symptoms in adults with MDD by day 43. Conducted by Intra-Cellular Therapies following FDA approval in 2025, the study assessed 480 adults with inadequate response to 1 or 2 antidepressants. Lumateperone targets serotonin, dopamine, and glutamate neurotransmission, acting as a 5-HT2A antagonist while modulating D2, D1, AMPA, and NMDA activity.

Primary endpoints—changes in MADRS and CGI-S scores—were met, with notable patient-reported improvements. The drug was generally well tolerated, with common adverse events including dizziness, somnolence, and nausea.

Intersecting Care: Dermatologic Conditions and Psychiatric Outcomes

Psychological Distress Greater in Patients With Androgenetic Alopecia

A systematic review of 13 studies involving 2737 patients with androgenetic alopecia (AGA) and 17,382 controls found that individuals with AGA experience significantly greater levels of generalized anxiety, social anxiety, depression, and perceived stress. The condition also negatively impacts self-esteem, body image, life satisfaction, and social functioning. Despite some conflicting findings on depression, the review highlights the substantial psychosocial burden of AGA.

Investigators from Beijing Changping Hospital recommend routine psychological assessment in clinical practice and integrated care with dermatologists and psychologists, including cognitive-behavioral therapy or pharmacotherapy when needed, to support emotional well-being and improve quality of life for patients living with AGA.

2025 Year in Review: Key Approvals, Trials

In 2025, psychiatry advanced on multiple fronts, with new FDA approvals, clinical innovations, and emerging therapies enhancing care across depression, ADHD, schizophrenia, and anxiety. Esketamine (SPRAVATO®) became the first monotherapy for treatment-resistant depression, while lumateperone (CAPLYTA) and BrainsWay’s Deep TMS offered novel adjunctive and noninvasive options for adolescents with MDD.

Long-acting injectables such as TEV-‘749 for schizophrenia and expanded-use risperidone and buprenorphine formulations improved adherence and maintenance strategies. ADHD management progressed with centanafadine and solriamfetol, showing rapid, sustained symptom improvement, and phase 2b trials of MM120 (LSD) demonstrated durable reductions in generalized anxiety. Combined with expert guidance on dermatologic comorbidities, relapse prevention, and safe psychedelic use, these developments in 2025 broadened the tools available to clinicians and reinforced more individualized, patient-centered approaches in psychiatric care.

Psychiatry saw significant advancements in 2025, marked by FDA submissions, clinical trial results, and insights into mental health's connection to broader medical conditions. Notable developments included Teva's submission of TEV-‘749 for schizophrenia, which showed promise in improving adherence and reducing relapses. Lumateperone demonstrated rapid symptom improvement in major depressive disorder. Additionally, a review highlighted the psychological impact of androgenetic alopecia, emphasizing the need for integrated care. Overall, 2025 brought new therapies and innovations, enhancing treatment options and promoting individualized, patient-centered psychiatric care.

December 2025 psychiatry updates: Teva files TEV-‘749 for schizophrenia, lumateperone boosts MDD outcomes, AGA tied to mental health, and a look back at 2025 advances.