adalimumab (Mabura)

Increasing formulary adoption of adalimumab biosimilars and differential cost-sharing in Medicare Part D plans.

Feng Alina S AS, Liao Wilson W

Adalimumab was among the first biologics to face widespread biosimilar competition following US market entry of multiple adalimumab biosimilars in 2023. However, Medicare Part D formulary adoption of these products and their associated specialty-tier cost-sharing requirements remain unknown. To evaluate adalimumab biosimilar adoption and associated cost-sharing patterns across Medicare Part D formularies, Centers for Medicare & Medicaid Services (CMS) Medicare Part D Formulary and Plan Benefit Package files were analyzed. Plans were categorized as covering originator adalimumab-only, both originator and biosimilar products (dual coverage), or biosimilars-only. In 2023, all Medicare Part D plans covering adalimumab listed only the originator product. By 2024, 52.5% of plans provided dual coverage, increasing to 79.9% in 2025. Biosimilar-exclusive coverage increased from 8.6% of plans in 2025 to 45.9% in 2026, while originator-only coverage declined to 0.8%. Median specialty-tier coinsurance differed according to coverage strategy. In 2026, median specialty-tier coinsurance was 33% among originator-only plans, 27% among dual-coverage plans, and 25% among biosimilar-only plans. Medicare Part D formularies rapidly included adalimumab biosimilars following market entry, with substantial growth in biosimilar-exclusive coverage by 2026. Specialty tier coinsurance varied by medication coverage type, suggesting that evolving formulary strategies may influence beneficiary cost-sharing requirements.

Comparative effectiveness of adalimumab versus infliximab in children with Crohn's disease: real-world data from the prospective PIBD-SETQuality inception cohort study.

Vuijk Stephanie A SA, Klomberg Renz C W RCW, Katgert Eva E, Wessels Margreet M S MMS et al.

Infliximab and adalimumab are effective anti-tumor necrosis factor (anti-TNF) therapies for the treatment of pediatric Crohn's disease (CD). The aim of this study was to compare the effectiveness of infliximab and adalimumab in a real-world cohort of children with CD. Data from biological-naïve children with luminal CD (age 3-18 years) who commenced anti-TNF and completed at least 1 year of follow-up were collected from the prospective multicenter observational PIBD-SETQuality study. The primary outcome was steroid-free clinical remission (SFCR), defined as clinical remission (weighted pediatric Crohn's disease activity index [wPCDAI] <12.5) without systemic steroids or luminal surgery at 1 year. The relative risk (RR) of SFCR was calculated using standardization, correcting for the following baseline covariates: age, upfront anti-TNF, C-reactive protein, erythrocyte sedimentation rate, albumin, leukocytes, disease behavior, wPCDAI, perianal disease, and concomitant immunomodulator use. Secondary outcomes included the durability of anti-TNF treatment without luminal surgery. Between January 1, 2017, and June 14, 2024, 178 patients with anti-TNF were included (infliximab: n = 121 [68%], adalimumab: n = 57 [32%]). At 12 months, 34/56 (61%) patients treated with adalimumab and 66/120 (55%) patients treated with infliximab had reached SFCR. The RR of SFCR at 1 year with adalimumab compared to infliximab was 1.25 (95% confidence interval [CI] 0.94-1.66], P = .13. Adalimumab was associated with a significant lower adjusted hazard ratio (aHR) of treatment discontinuation than infliximab in patients with a concomitant immunomodulator (aHR 0.17 [95% CI 0.04-0.75], P = .020), adjusted for upfront anti-TNF. In this prospective cohort of children with CD, adalimumab and infliximab showed comparable clinical effectiveness 1 year after the start of anti-TNF treatment. The ClincalTrials.gov ID of this study is NCT03571373.

Pregnancy Outcome in a Patient With DADA2 Syndrome on Continued Adalimumab Therapy.

Pridhivi Bhargavi B, Naidu Gsrsnk G, Bhatia Prateek P, Lee Pui Y PY et al.

Factors Associated With PASI90 Maintenance Without Flare-Up and Predictors of Biologics Discontinuation in Psoriasis: Two-Center Retrospective Cohort Study in Korea.

Choi Mi Soo MS, Yeom Kyujin K, Jung Seung-Won SW, Hong Seung Phil SP et al.

Biologics targeting key cytokines have enabled near-complete clearance in psoriasis treatment. As 90% reduction in the Psoriasis Area and Severity Index (PASI90) emerges as a meaningful goal of treatment, maintaining PASI90 without flare-up has become important. To identify factors associated with PASI90 maintenance for ≥1 year without flare-up and predictors of drug discontinuation. This multicenter retrospective cohort study included moderate-to-severe plaque psoriasis patients treated with adalimumab, ustekinumab, secukinumab, ixekizumab, guselkumab, or risankizumab (2010-2022). Treatment courses were defined as "Episodes." Patients with ≥2 years of therapy were analyzed. Relative risks (RR) for PASI90 maintenance were estimated using generalized linear mixed models, and Cox proportional hazards models assessed drug discontinuation. Among 136 patients (189 episodes), 40.1% of 162 eligible episodes achieved PASI90 maintenance without flare-up for ≥1 year. Secukinumab significantly increased the likelihood of PASI90 maintenance (RR, 2.1; 95% confidence interval [CI], 1.27-3.49). Body mass index (BMI) <30 and first biologic episode showed favorable with only trend toward significance. Psoriasis Area and Severity Index response at week 16 and first assessment strongly predicted maintenance (area under the curve, 0.80-0.82). Regarding drug discontinuation, drug were discontinued in 28.6% of episodes; BMI ≥30, family history of psoriasis, and adalimumab (hazard ratio, 4.50; 95% CI, 1.57-12.90 vs. ustekinumab) were associated with higher risk of drug discontinuation. Secukinumab, lower BMI, and biologic-naïve status favored durable PASI90 without flare-up. Obesity, family history, and adalimumab predicted drug discontinuation. Early treatment response strongly predicted long-term efficacy.