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Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Rheumatic Heart Disease III: Medical Management01:21

Rheumatic Heart Disease III: Medical Management

Rheumatic heart disease (RHD) management can be divided into two main strategies: prevention and long-term management.Primary PreventionPrimary prevention focuses on timely diagnosis and management of group A streptococcal pharyngitis to prevent acute rheumatic fever. The most widely used antibiotic for treating this condition is intramuscular benzathine penicillin G.Acute Rheumatic Fever TreatmentThe primary treatment goal for a patient diagnosed with acute rheumatic fever is to suppress the...

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Phase 3 Trial of Secukinumab in Polymyalgia Rheumatica.

John H Stone1,2, Frank Buttgereit3,4, Alain Saraux5

  • 1Division of Rheumatology, Inflammation, and Immunology, Massachusetts General Hospital, Boston.

The New England Journal of Medicine
|June 3, 2026
PubMed
Summary

Secukinumab significantly improved sustained remission in polymyalgia rheumatica patients compared to placebo. This interleukin-17A inhibitor offers a promising alternative to reduce reliance on glucocorticoids.

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Area of Science:

  • Rheumatology
  • Immunology
  • Clinical Trials

Background:

  • Polymyalgia rheumatica (PMR) is an inflammatory condition causing shoulder and hip pain/stiffness.
  • Glucocorticoids are primary treatment but lead to frequent relapses and side effects.
  • Secukinumab, an interleukin-17A inhibitor, is explored as an alternative therapy.

Purpose of the Study:

  • To evaluate the efficacy of secukinumab in achieving sustained remission in patients with relapsed polymyalgia rheumatica.
  • To assess the impact of secukinumab on reducing cumulative glucocorticoid dosage.
  • To compare the safety profiles of secukinumab versus placebo in PMR patients.

Main Methods:

  • A 52-week randomized controlled trial involving 381 patients with relapsed PMR.
  • Patients received secukinumab (300 mg or 150 mg) or placebo, alongside a 24-week prednisone taper.
  • Primary endpoint: sustained remission from week 12 to week 52.

Main Results:

  • Sustained remission at 52 weeks was significantly higher in both secukinumab groups (41.2% and 40.6%) compared to placebo (20.4%) (P<0.001).
  • Mean cumulative glucocorticoid doses were lower with secukinumab (1603.7 mg and 1683.2 mg) versus placebo (2093.0 mg).
  • Adverse events were similar between groups, though nasopharyngitis and infections were more frequent with secukinumab.

Conclusions:

  • Secukinumab, combined with a glucocorticoid taper, effectively increases sustained remission rates in relapsed PMR.
  • This treatment approach leads to reduced cumulative glucocorticoid exposure compared to placebo.
  • Secukinumab demonstrates a favorable benefit-risk profile for managing relapsed polymyalgia rheumatica.