Secukinumab Shows Strong Efficacy in Polymyalgia Rheumatica, Phase 3 Trial

In order to thoroughly assess the possibility of biological targeting being effective in overcoming the reliance on steroids, researchers conducted a rigorous 52-week randomized, double-blind, placebo-controlled trial. For the purposes of this study, researchers identified patients who had suffered from a recent relapse of symptoms associated with their polymyalgia rheumatica disease. Patients for the trial were randomly divided into three different treatment groups. This randomization included a high dose biological group that received 300 mg of secukinumab; a low dose biological group that received 150 mg of secukinumab; and the last group, a placebo group, that was provided with a placebo. In order to maintain consistent medical standards, all the participants of the trial were given a highly regimented 24-week regimen of tapering of prednisone for withdrawal of oral steroids.

The primary endpoint for assessing the effectiveness of the treatment was the attainment of sustained clinical remission in the 52nd week, where there was no manifestation of PMR symptoms along with an absence of new cases of giant cell arteritis from week 12 until week 52. The other important parameters measured were the total cumulative annual doses of glucocorticoids taken and the safety profile.

Key findings:

• The randomized controlled trial was successful in recruiting a total of 381 patients with recent relapse for its phase 3 study, evenly dividing the participants into three groups where 127 patients were allocated in each group.
• Of those patients who had been given 300 mg secukinumab, 41.2% were found to be under clinical remission after 52 weeks, while 40.6% were reported in the case of 150 mg secukinumab; this figure stood at only 20.4% among those receiving placebo (P < 0.001 in both cases).
• The adjusted annual mean dose of glucocorticoids for the 300 mg group was calculated to be 1603.7 mg.
• On average, patients taking 150 mg secukinumab required an annual glucocorticoid dose of 1683.2 mg.
• This figure went up to 2093.0 mg in the placebo group, which relied mostly on conventional treatments.
• The percentage of patients affected by serious adverse reactions was similar among all groups and quite equal too.
• In the 300 mg group, it was recorded to be 13.5%, 15.9% in the 150 mg group, and 14.2% in the placebo group.
• Nasopharyngitis, systemic allergic reactions, UTIs, superficial mycoses, and lumbar pain were some of the mild to moderate treatment-emergent adverse effects.

In conclusion, in patients suffering from relapsing polymyalgia rheumatica, the use of secukinumab together with a 24-week glucocorticoid taper was associated with significantly more patients achieving remission and also required fewer amounts of glucocorticoids than a 24-week taper of glucocorticoids alone. This extremely strong data generated through phase 3 trials provides an absolutely solid basis for current rheumatology and demonstrates how successful biologic drugs can disrupt the dependence on steroids.

Reference:

Stone, J. H., Buttgereit, F., Saraux, A., Schmidt, W. A., Dejaco, C., Spiera, R., Dasgupta, B., Drescher, E., Jordan, A., Novosad, L., Nakagomi, D., Koyama, Y., Duran-Barragan, S., Tracey, G., Ruyssen-Witrand, A., Rubbert Roth, A., Fang, J., Ng, J., Hiremath, R., … REPLENISH Investigators. (2026). Phase 3 trial of secukinumab in polymyalgia rheumatica. The New England Journal of Medicine, NEJMoa2602567. https://doi.org/10.1056/NEJMoa2602567