EU Approves Cosentyx for Polymyalgia Rheumatica: A New Option When Steroids Aren’t Enough

MEDISEARCHER NEWS

European Union · Polymyalgia Rheumatica · 23 October 2026

Adults with polymyalgia rheumatica who struggle to control their disease while reducing steroid treatment have a new treatment option in Europe.

The European Commission has approved Cosentyx (secukinumab) for adults with polymyalgia rheumatica who have had an inadequate response to glucocorticoids or who experience a relapse while their glucocorticoid treatment is being tapered.

The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2026 and makes Cosentyx the first IL-17A inhibitor approved in Europe for polymyalgia rheumatica.

The approval is particularly relevant because glucocorticoids such as prednisolone have long been central to PMR treatment, but some patients relapse as their dose is reduced and prolonged steroid exposure can cause significant side effects.

The Phase III trial supporting the new indication found that secukinumab approximately doubled the proportion of patients achieving sustained remission at one year compared with placebo while also reducing cumulative glucocorticoid exposure.

What is polymyalgia rheumatica?

Polymyalgia rheumatica, commonly abbreviated to PMR, is an inflammatory rheumatic condition that primarily affects older adults.

It typically causes pain and stiffness around the shoulders and hips and can also affect the neck.

Symptoms can be particularly severe after waking or after periods of inactivity and may make everyday activities such as getting dressed, getting out of bed or raising the arms difficult.

PMR occurs almost exclusively in adults over 50 and becomes increasingly common with age.

The condition is particularly associated with populations of Northern European ancestry, although it can occur in people from other backgrounds.

How has polymyalgia rheumatica traditionally been treated?

Glucocorticoids, commonly referred to as corticosteroids or steroids, remain the cornerstone of treatment for PMR.

Medicines such as prednisolone can often produce a rapid improvement in pain and stiffness.

The challenge is what happens afterwards.

Once symptoms are controlled, the glucocorticoid dose is generally reduced gradually. Some people can successfully stop treatment, while others experience recurrent symptoms as their dose is lowered.

That can result in repeated increases in steroid dose or prolonged treatment.

Long-term glucocorticoid exposure can contribute to complications including osteoporosis, fractures, diabetes, hypertension, infections, cataracts and other adverse effects.

Reducing reliance on prolonged steroid treatment has therefore become an important goal in PMR management.

Who is Cosentyx approved for?

The new European indication does not mean that Cosentyx is intended to replace glucocorticoids as the standard initial treatment for every person newly diagnosed with PMR.

The European indication covers adults with polymyalgia rheumatica who:

• have had an inadequate response to glucocorticoids; or
• experience a relapse while glucocorticoids are being tapered.

This makes the approval particularly relevant to people whose disease proves difficult to control as steroid treatment is reduced.

What is Cosentyx?

Cosentyx is the brand name for secukinumab, a monoclonal antibody that selectively targets the inflammatory protein interleukin-17A, or IL-17A.

Blocking IL-17A reduces inflammatory signalling involved in several immune-mediated diseases.

Cosentyx is not a new medicine. It has been used in Europe for years for several inflammatory conditions, including plaque psoriasis, psoriatic arthritis and axial spondyloarthritis.

What is new is its authorisation specifically for polymyalgia rheumatica.

How effective was Cosentyx in polymyalgia rheumatica?

The European approval is supported by the Phase III REPLENISH trial, a randomized, double-blind, placebo-controlled study involving 381 adults with recently relapsed polymyalgia rheumatica.

Participants were randomly assigned to receive:

• secukinumab 300 mg;
• secukinumab 150 mg; or
• placebo.

There were 127 participants in each treatment group.

All three groups also received prednisone according to a planned 24-week tapering schedule.

The main outcome was sustained remission at week 52.

Researchers defined this as achieving remission and maintaining it from week 12 through week 52 without disease flare requiring escape or rescue treatment and without a new diagnosis of giant-cell arteritis requiring such treatment.

How many patients achieved sustained remission?

At week 52, sustained remission was achieved by:

• 41.2% of patients receiving secukinumab 300 mg;
• 40.6% of patients receiving secukinumab 150 mg; and
• 20.4% of patients receiving placebo.

Both secukinumab doses therefore produced substantially higher sustained-remission rates than placebo in the trial.

The results were published in the New England Journal of Medicine in June 2026.

Did Cosentyx reduce steroid use?

Yes. This is one of the most clinically relevant findings from REPLENISH.

The adjusted mean cumulative glucocorticoid dose over the year was:

• 1,603.7 mg in the secukinumab 300 mg group;
• 1,683.2 mg in the secukinumab 150 mg group; and
• 2,093.0 mg in the placebo group.

The results therefore suggest that secukinumab can help some patients maintain disease control while reducing their overall exposure to glucocorticoids.

That matters because cumulative steroid exposure is an important concern in a disease that primarily affects older adults, who may already have conditions that increase their risk of steroid-related complications.

Does Cosentyx replace steroids for PMR?

Not initially.

The approved treatment approach involves using Cosentyx together with a tapering course of glucocorticoids.

For adults with PMR, the recommended Cosentyx dose is 150 mg by subcutaneous injection.

Initial doses are administered at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance treatment.

Cosentyx is initially used in combination with a tapering glucocorticoid course. After the glucocorticoid treatment has been tapered, Cosentyx can continue as monotherapy.

The objective is therefore not simply to stop steroids immediately, but to improve disease control while allowing glucocorticoid exposure to be reduced.

Why is reducing steroid exposure important?

Glucocorticoids can be extremely effective medicines, and they remain an important part of PMR treatment.

Problems can arise when treatment continues for long periods or repeated disease relapses require higher cumulative doses.

Potential complications of prolonged systemic glucocorticoid treatment include:

• osteoporosis and increased fracture risk;
• higher blood glucose and diabetes;
• high blood pressure;
• weight gain;
• increased susceptibility to infection;
• cataracts and other eye complications;
• skin and muscle changes; and
• adrenal suppression.

The risk varies between individuals and depends on factors including dose, duration of treatment, age and existing health conditions.

A treatment that helps maintain PMR remission while reducing cumulative glucocorticoid exposure could therefore have benefits beyond controlling pain and stiffness.

What are the side effects of Cosentyx?

Secukinumab has an established safety profile from its use in other inflammatory diseases, but treatment can still cause adverse effects and requires appropriate medical assessment.

In the REPLENISH trial, serious adverse events occurred in:

• 13.5% of patients receiving secukinumab 300 mg;
• 15.9% receiving secukinumab 150 mg; and
• 14.2% receiving placebo.

Nasopharyngitis, hypersensitivity reactions, urinary tract infections, fungal infections and back pain occurred more frequently in the secukinumab groups than in the placebo group.

Because secukinumab modifies immune signalling, infection risk and other contraindications or precautions need to be considered before treatment.

Patients should use Cosentyx only under the supervision of an appropriately qualified healthcare professional.

Is Cosentyx the first non-steroid treatment for polymyalgia rheumatica?

No.

It would be misleading to interpret the European approval as meaning that no other steroid-sparing approaches exist for PMR.

Other medicines, including methotrexate and treatments targeting the interleukin-6 receptor pathway, may be used in selected patients.

What is new is that Cosentyx is the first IL-17A inhibitor authorised in Europe specifically for adults with polymyalgia rheumatica.

The approval therefore adds another biological pathway that doctors can target when glucocorticoids alone are insufficient or disease returns during tapering.

How does this fit with changing PMR treatment guidelines?

The Cosentyx approval arrives as treatment strategies for polymyalgia rheumatica are increasingly focused on reducing prolonged glucocorticoid exposure.

Updated 2026 guidance from the British Society for Rheumatology continues to describe glucocorticoids as the cornerstone of PMR treatment but recommends consideration of steroid-sparing therapies in appropriate patients.

The guideline includes earlier consideration of methotrexate and recommends considering an IL-6 receptor antagonist for people who respond inadequately to glucocorticoids or cannot successfully taper them.

The European Cosentyx approval introduces IL-17A inhibition as another treatment strategy supported by Phase III evidence.

Future treatment guidelines will determine how secukinumab is positioned relative to other steroid-sparing options as clinical experience grows.

Is Cosentyx now approved for PMR throughout the EU?

Yes. The European Commission decision extends the Cosentyx marketing authorisation to include this PMR indication across the European Union.

The EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the new indication on 17 September 2026.

The European Commission subsequently approved the indication on 21 October 2026.

This is different from some recent MediSearcher stories where a medicine had received a positive CHMP recommendation but was still awaiting the final Commission decision.

For Cosentyx and PMR, that central EU regulatory step has now been completed.

Can patients get Cosentyx for PMR immediately?

Not necessarily.

EU marketing authorisation establishes that the medicine can be marketed for the approved indication, but it does not guarantee immediate publicly funded access in every member state.

Pricing and reimbursement decisions are generally handled nationally.

Health authorities and insurers may need to determine whether Cosentyx will be reimbursed for PMR, which patients qualify for funded treatment and whether particular treatment steps must be tried first.

That means practical access could differ between Germany, France, Italy, Spain, the Netherlands, Ireland, Sweden, Poland, Malta and other EU countries.

MediSearcher’s guide to prescription costs and reimbursement in the EU explains why regulatory approval and publicly funded patient access are separate processes.

What should patients with PMR do?

People currently being treated successfully with glucocorticoids should not interpret the Cosentyx approval as a reason to change or stop their treatment.

Glucocorticoids remain an established first-line treatment for PMR, and steroid doses should not be reduced or stopped suddenly without medical guidance.

The new Cosentyx indication is particularly relevant to adults whose disease has not responded adequately to glucocorticoids or whose symptoms return during steroid tapering.

Patients in those situations can discuss available steroid-sparing treatment options with their doctor or rheumatology team.

What happens next?

The European regulatory decision is complete, but the next stage will occur at national level.

Key developments to watch include:

• national pricing and reimbursement decisions;
• updated clinical treatment pathways;
• the timing of routine PMR access in individual EU countries;
• how clinicians position secukinumab relative to existing steroid-sparing treatments; and
• longer-term evidence on remission, glucocorticoid exposure and safety in routine clinical practice.

Regulatory reviews of secukinumab for polymyalgia rheumatica are also continuing outside Europe, including in the United States and Japan.

MediSearcher will update this article as significant European reimbursement and patient-access decisions emerge.

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Sources and verification

MediSearcher reviewed the following primary and authoritative sources when preparing this article:

• European Medicines Agency: Cosentyx variation to marketing authorisation, including the positive CHMP opinion and approved proposed indication for polymyalgia rheumatica
• New England Journal of Medicine: Phase 3 Trial of Secukinumab in Polymyalgia Rheumatica — REPLENISH trial efficacy, glucocorticoid exposure and safety results
• Novartis: European Commission approval of Cosentyx for polymyalgia rheumatica, announced 21 October 2026
• British Society for Rheumatology / Rheumatology: 2026 guideline for the treatment of polymyalgia rheumatica, including glucocorticoid tapering and steroid-sparing treatment recommendations

MediSearcher provides general information about medicines, medicine regulation and healthcare access. Cosentyx (secukinumab) has received European Commission approval for adults with polymyalgia rheumatica who have had an inadequate response to glucocorticoids or experience relapse during glucocorticoid tapering. Availability, reimbursement and eligibility can differ between EU member states. Patients should not stop or alter glucocorticoid treatment without medical guidance. This article does not provide personal medical advice.