Amid Effective TNF-α Inhibitors, What Clinical Improvements Do Rheumatologists and Payers Expect from Emerging Therapies with a Different Mechanism of Action?

Axial spondyloarthritis (Ax SpA) is a chronic inflammatory disease of the axial skeleton (sacroiliac joints and spine) that results in chronic back pain and stiffness. Ankylosing spondylitis (AS) is a type of Ax SpA with radiographic abnormalities of the sacroiliac joint; nonradiographic Ax SpA is a type of Ax SpA with no evidence of structural damage but the signs and symptoms of Ax SpA. Key treatment goals for Ax SpA include improving signs and symptoms of the disease, improving physical function, slowing or preventing structural damage, and improving the patient’s quality of life. Treatment of moderate to severe disease is dominated by tumor necrosis factor-alpha (TNF-α ) inhibitors; however, the market is poised to expand with the anticipated approval of novel biologic and oral small-molecule therapies that will attempt to compete with the established therapies on the basis of novel mechanisms of action, efficacy, safety, and/or differences in formulation and dosing frequency.

Questions Answered in This Report:

  • Improvement in signs and symptoms of the disease is a key goal in the treatment of Ax SpA. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European rheumatologists weight specific efficacy end points and other drug attributes in their prescribing decisions for Ax SpA?

  • Greater ability to inhibit the progression of structural damage and lower risk of serious/opportunistic infections are key areas of unmet need in Ax SpA, according to the insights of surveyed U.S. and European rheumatologists. Which therapies in development for Ax SpA are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  • The percentage of patients achieving an Assessment of SpondyloArthritis International Society (ASAS20) response rate and the percentage of patients with improvement in their Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new Ax SpA therapies. What trade-offs across these and other clinical attributes are U.S. rheumatologists willing to make when considering the use of emerging therapies for Ax SpA? Based on the trade-offs in price and performance across key drug attributes that U.S. rheumatologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for Ax SpA?

  • Based on their clinical profile, golimumab (Janssen Biotech/Merck/Mitsubishi Tanabe’s Simponi) and certolizumab pegol (UCB/Astellas Pharma’s Cimzia) are the current clinical gold standards in our Drug Comparator Model. What attributes do thought leaders believe differentiate these therapies from competing current therapies and emerging therapies? Will any therapies in development challenge golimumab and/or certolizumab pegol as the future gold standard in 2018 or 2023?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for axial spondyloarthritis:

- ASAS20 response rate (% of patients achieving ASAS20 at 12-24 weeks [placebo-adjusted]).

- BASDAI change from baseline (mean change from baseline in BASDAI at 12-24 weeks [placebo-adjusted]).

- Bath Ankylosing Spondylitis Metrology Index (BASMI) change from baseline (mean change from baseline in BASMI at 12-24 weeks [placebo-adjusted]).

- Spondyloarthritis Research Consortium of Canada (SPARCC) MRI change from baseline (mean change from baseline in SPARCC MRI Score at 12 weeks [placebo-adjusted]).

- Incidence of serious/opportunistic infections (incidence of serious infections per 100 patient-years [placebo-adjusted]).

- Delivery burden (dosing formulation [e.g., oral, IV, SC] and frequency [e.g., daily, weekly, monthly]).

- Price/day.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for axial spondyloarthritis:

- Improved ASAS20 response rate at 12-24 weeks.

- Improvement in BASMI change from baseline at 12-24 weeks.

- Lower rate of serious infections.

- Improved delivery burden.

Physicians surveyed: 60 U.S. and 32 European rheumatologists.

Payers surveyed: 21 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Adalimumab (AbbVie/Eisai’s Humira)

- Etanercept (Amgen/Pfizer/Takeda’s Enbrel)

- Infliximab (Janssen Biotech/Merck/Mitsubishi Tanabe’s Remicade)

- Golimumab (Janssen Biotech/Merck/Mitsubishi Tanabe’s Simponi)

- Certolizumab pegol (UCB/Astellas Pharma’s Cimzia)

Emerging Therapies

- Secukinumab (Novartis’s Cosentyx)

- Apremilast (Celgene’s Otezla)

- Ustekinumab (Janssen Biotech’s Stelara)

- Tofacitinib (Pfizer/Takeda’s Xeljanz)


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