Anifrolumab extension

Team: Lupus Legends: The Anifrolumab Edition

Base article: Kalunian KC, Furie R, Morand EF, Bruce IN, Manzi S, Tanaka Y, Winthrop K, Hupka I, Zhang LJ, Werther S, Abreu G, Hultquist M, Tummala R, Lindholm C, Al-Mossawi H. A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus. Arthritis Rheumatol. 2023 Feb;75(2):253-265. doi: 10.1002/art.42392. Epub 2022 Nov 11. PMID: 36369793; PMCID: PMC10098934.

Authors: The Medical University of South Carolina Fellowship Program

  1. Rachael Werner, MD, PhD, 3rd year fellow
  2. Gretchen Santana, MD, 2nd year fellow
  3. Rashi Vora, MD, 2nd year fellow
  4. Megan Donaldson, DO, 1st year fellow
  5. Maggie Smythe, MD, 1st year fellow
  6. Brandon Lew, MD, 1st year fellow
  7. Jennifer Schmidt, MD, Associate Program Director
  8. Faye Hant, DO, Program Director

Team Overview: 

In the heated competition of chronic illness treatments, “A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of anifrolumab in Active Systemic Lupus Erythematosus” is the undisputed MVP!

For patients, this trial shows that anifrolumab can offer relief during the overtime of managing chronic conditions. This trial shows strong data in using anifrolumab to reduce steroid usage, at least off the court.

For researchers, this trial offers invaluable insights on how long-term treatment options like anifrolumab can shape the future of chronic illness management. This study isn’t just a win for lupus—it shines a spotlight on interferon-targeted therapies which are also being explored in conditions like dermatomyositis and systemic sclerosis (1, 2). Plus, it’s a great gameplan for running long-term placebo-controlled trials.

In the competition of managing systemic lupus erythematosus (SLE), anifrolumab has emerged as a key player. This phase III long term extension (LTE) trial was like the championship finals, where patients who completed the initial TULIP trial were either continued on anifrolumab 300 mg, switched from 150mg to 300mg dosing or remained on the bench with placebo.

This trial showed that anifrolumab maintained a strong defense against serious adverse events (SAEs), with an exposure-adjusted incidence rate (EAIR) of 8.5 per 100 patient-years, outscoring the placebo team’s 11.2. Similarly, when it came to adverse events leading to treatment discontinuation, anifrolumab had fewer fouls and less time on the sidelines (EAIR of 2.5 compared to placebo’s 3.2).

In the infection zone, both teams were evenly matched, with non-opportunistic serious infections occurring at comparable rates. On the offense, anifrolumab excelled by reducing the need for glucocorticoids and improving SLE disease activity. This strategic move helped anifrolumab outscore placebo in overall disease management.

In conclusion, this LTE study was the longest placebo-controlled clinical trial in the SLE arena, and it reinforced anifrolumab’s favorable benefit-risk profile. Whether you’re advancing treatments, improving patient outcomes, or looking for a new research breakthrough, anifrolumab is THE player to watch for patients with moderate-to-severe SLE receiving standard therapy. Don’t sit on the bench—this is the one to watch for patients now and in the future!

Related content on theMednet.org:

How will you utilize newly FDA approved anifrolumab for SLE in your practice?

 

References:

  1. Shaw, K. S., Hashemi, K. B., Castillo, R. L., Rainone, E., Ho, A. W., Kahn, P. J., Oza, V. S., Femia, A., & Vleugels, R. A. (2024). Anifrolumab in recalcitrant cutaneous dermatomyositis: A Multicenter Retrospective Cohort study. Journal of the American Academy of Dermatology91(6), 1217–1219.  https://doi.org/10.1016/j.jaad.2024.07.1491
  2. Khanna, D., Denton, C. P., Assassi, S., Kuwana, M., Allanore, Y., Domsic, R. T., Kleoudis, C., Xu, J., Csomor, E., Seo, C., Albulescu, M., Tummala, R., Al-Mossawi, H., Kalyani, R. N., & Del Galdo, F. (2024). A randomised, parallel-group, double-blind, placebo-controlled phase 3 study to Determine the effectiveness of the type I interferon receptor antibody, Anifrolumab, In SYstemic sclerosis: DAISY study design and rationale. Clinical and Experimental Rheumatology. https://doi.org/10.55563/clinexprheumatol/s8qcyu

 

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