Secukinumab at the ACR 2015 Meeting in San Francisco

There have been more than 10 publications on secukinumab at the ACR 2015 Annual Meeting in San Francisco. I feel like watching a poker game in the end phase, an all-in-call.

Xenofon Baraliakos and colleagues looked at: “Effect of Interleukin-17A Inhibition on Spinal Radiographic Changes through 2 Years in Patients with Active Ankylosing Spondylitis: Results of a Phase 3 Study with Secukinumab”. Conclusion: “[…]No radiographic progression was observed in ~80% of the pts receiving secukinumab over 104 wks. […]”. Since the tofacitinib debacle concerning EMEA approval, we know how important radiographic data are.

Juergen Braun and colleagues presented: “Secukinumab Significantly Improves Signs and Symptoms of Active Ankylosing Spondylitis: 52-Week Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial with Subcutaneous Loading and Maintenance Dosing”. In conclusions the authors state: “Secukinumab 150 mg s.c. provided sustained improvements over 52 weeks in the signs and symptoms of AS, reducing inflammation, and improving physical function and health-related quality of life. Secukinumab was well tolerated; safety findings were consistent with previous reports.”

The second set of studies is on psoriatic arthritis.

Arthur Kavanaugh and collegues looked at: “Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Psoriatic Arthritis in Anti-TNF-Naive Patients and Those Previously Exposed to Anti-TNF Therapy: 52-Week Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial with Subcutaneous Dosing”. Conclusion: “Secukinumab provided sustained improvements in the signs and symptoms of PsA in both anti‒TNF-naïve and anti‒TNF-IR pts.”.

I’ll skip a few interesting studies, but will list these under references.

Alice B. Gottlieb and colleagues presented: “Secukinumab Reduces the Burden of Nail and Skin Disease in Patients with Psoriasis and Patients with Psoriatic Arthritis: Results from Two Phase 3 Studies”. Conclusion: “Secukinumab improved nail and skin symptoms in pts with psoriasis with significant nail involvement and in pts with concomitant PsA and nail involvement.” I guess, we all expected that it would be this way!

And Alice B. Gottlieb also presented: “Secukinumab Improves Skin Symptoms and Physical Functioning Compared with Ustekinumab in Patients with Moderate to Severe Psoriasis with Concomitant Psoriatic Arthritis: Subanalysis of a Randomized, Double Blind, Parallel-Group, Active Comparator-Controlled Phase 3b Trial”. Conclusion: “Secukinumab was superior to ustekinumab at improving skin symptoms in patients with moderate to severe plaque psoriasis. In the small sub-group of patients with psoriasis and concomitant PsA, secukinumab showed a trend for improving skin symptoms and physical functioning compared with ustekinumab.” I must admit that this surprised me.

Laure Gossec an colleagues looked at: “Relationship Between Improvements in Fatigue and Signs & Symptoms of Active Psoriatic Arthritis: a Sub-Analysis of a Phase 3 Study with Secukinumab”. Conclusion: “Secukinumab improved fatigue in patients with active PsA regardless of prior anti-TNF therapy. A relationship between improvement in fatigue and improvements in the signs and symptoms of PsA was only shown for ACR 20 response and not for other assessments of disease. These results suggest that fatigue in PsA is not strongly related to disease activity but was still improved by secukinumab.” I’ll have to look all over the studies if improvement of fatigue has been addressed elsewhere.

Secukinumab is already available under the name Cosentyx in Germany for the indication of moderate to severe plaque psoriasis. In the U.S. Secukinumab had been approved by the FDA even earlier. Now, we rheumatologists have to wait, until FDA and/or EMEA approve the use in psoriatic arthritis, ankylosing spondylitis, and other inflammatory rheumatic conditions. I’ll be happy to have a new tool, though we still don’t know if a certain consecutive order of biologics and the small molecule should be recommended.

PS. Since yesterday (26.11.2015) Cosentyx has been approved in Germany for the indications of psoriatic arthritis and ankylosing spondylitis. So, the waiting is over.

References.

Baraliakos X, Deodhar AA, Braun J, Baeten D, Dougados M, Sieper J, Emery P, Readie A, Martin R, Mpofu S, Richards H. Effect of Interleukin-17A Inhibition on Spinal Radiographic Changes through 2 Years in Patients with Active Ankylosing Spondylitis: Results of a Phase 3 Study with Secukinumab [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/effect-of-interleukin-17a-inhibition-on-spinal-radiographic-changes-through-2-years-in-patients-with-active-ankylosing-spondylitis-results-of-a-phase-3-study-with-secukinumab/. Accessed November 16, 2015.

Braun J, Deodhar AA, Sieper J, Dougados M, Porter B, Andersson M, Richards H. Secukinumab Significantly Improves Signs and Symptoms of Active Ankylosing Spondylitis: 52-Week Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial with Subcutaneous Loading and Maintenance Dosing [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/secukinumab-significantly-improves-signs-and-symptoms-of-active-ankylosing-spondylitis-52-week-results-from-a-randomized-double-blind-placebo-controlled-phase-3-trial-with-subcutaneous-loading-and/. Accessed November 16, 2015.

Kavanaugh A, McInnes IB, Mease PJ, Hall S, Chinoy H, Kivitz AJ, Patekar M, Wang Z, Mpofu S. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Psoriatic Arthritis in Anti-TNF-Naive Patients and Those Previously Exposed to Anti-TNF Therapy: 52-Week Results from a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial with Subcutaneous Dosing [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/secukinumab-provides-sustained-improvements-in-the-signs-and-symptoms-of-active-psoriatic-arthritis-in-anti-tnf-naive-patients-and-those-previously-exposed-to-anti-tnf-therapy-52-week-results-from-a/. Accessed November 16, 2015.

Mease PJ, McInnes IB, Kirkham B, Kavanaugh A, Rahman P, van der Heijde D, Landewé RBM, Nash P, Pricop L, Wang Z, Mpofu S. Secukinumab Provides Sustained Improvements in Psoriatic Arthritis: 2-Year Efficacy and Safety Results from a Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/secukinumab-provides-sustained-improvements-in-psoriatic-arthritis-2-year-efficacy-and-safety-results-from-a-phase-3-randomized-double-blind-placebo-controlled-trial/. Accessed November 16, 2015.

Gottlieb AB, Reich K, Wang Z, Milutinovic M, Mpofu S. Secukinumab Reduces the Burden of Nail and Skin Disease in Patients with Psoriasis and Patients with Psoriatic Arthritis: Results from Two Phase 3 Studies [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/secukinumab-reduces-the-burden-of-nail-and-skin-disease-in-patients-with-psoriasis-and-patients-with-psoriatic-arthritis-results-from-two-phase-3-studies/. Accessed November 16, 2015.

Gottlieb AB, Thaci D, Blauvelt A, Milutinovic M, Mpofu S. Secukinumab Improves Skin Symptoms and Physical Functioning Compared with Ustekinumab in Patients with Moderate to Severe Psoriasis with Concomitant Psoriatic Arthritis: Subanalysis of a Randomized, Double Blind, Parallel-Group, Active Comparator-Controlled Phase 3b Trial [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/secukinumab-improves-skin-symptoms-and-physical-functioning-compared-with-ustekinumab-in-patients-with-moderate-to-severe-psoriasis-with-concomitant-psoriatic-arthritis-subanalysis-of-a-randomized-d/. Accessed November 16, 2015.

Betts KA, Mittal M, Joshi A, Song J, Bao Y. Relative Efficacy of Adalimumab Versus Secukinumab in Active Psoriatic Arthritis: A Matching-Adjusted Indirect Comparison [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/relative-efficacy-of-adalimumab-versus-secukinumab-in-active-psoriatic-arthritis-a-matching-adjusted-indirect-comparison/. Accessed November 16, 2015.

Gossec L, Kvien TK, Conaghan PG, Østergaard M, Cañete JD, Gaillez C, Mpofu S, Sherif B, Jugl S. Relationship Between Improvements in Fatigue and Signs & Symptoms of Active Psoriatic: Arthritis a Sub-Analysis of a Phase 3 Study with Secukinumab [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/relationship-between-improvements-in-fatigue-and-signs-symptoms-of-active-psoriatic-arthritis-a-sub-analysis-of-a-phase-3-study-with-secukinumab/. Accessed November 16, 2015.

Mease PJ, McInnes IB, Gottlieb AB, Widmer A, Pricop L, Mpofu S. Secukinumab Safety and Tolerability in Patients with Active Psoriatic Arthritis and Psoriasis: Results from a Pooled Safety Analysis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/secukinumab-safety-and-tolerability-in-patients-with-active-psoriatic-arthritis-and-psoriasis-results-from-a-pooled-safety-analysis/. Accessed November 16, 2015.

Deodhar AA, Baeten D, Sieper J, Porter B, Widmer A, Richards H. Safety and Tolerability of Secukinumab in Patients with Active Ankylosing Spondylitis: Pooled Safety Analysis of Two Phase 3, Randomized, Controlled Trials [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/safety-and-tolerability-of-secukinumab-in-patients-with-active-ankylosing-spondylitis-pooled-safety-analysis-of-two-phase-3-randomized-controlled-trials/. Accessed November 16, 2015.

Baeten D, Blanco R, Geusens P, Sieper J, Jui-Cheng T, Martin R, Porter B, Richards H. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Ankylosing Spondylitis in Anti-TNF-Naïve Patients and Those Previously Exposed to Anti-TNF Therapy: 52-Week Results from Two Randomized, Double-Blind, Placebo-Controlled Phase 3 Trials [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/secukinumab-provides-sustained-improvements-in-the-signs-and-symptoms-of-active-ankylosing-spondylitis-in-anti-tnf-naive-patients-and-those-previously-exposed-to-anti-tnf-therapy-52-week-results-from/. Accessed November 16, 2015.

Baeten D, Braun J, Sieper J, Dougados M, Deodhar AA, Baraliakos X, Porter B, Gong Y, Richards H. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Ankylosing Spondylitis: 2-Year Efficacy and Safety Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/secukinumab-provides-sustained-improvements-in-the-signs-and-symptoms-of-active-ankylosing-spondylitis-2-year-efficacy-and-safety-results-from-a-phase-3-randomized-double-blind-placebo-controlled/. Accessed November 16, 2015.