Where Are the Remaining Areas of Opportunity for Emerging Non-TNF Biologics and Oral Agents in the Increasingly Crowded Psoriatic Arthritis Market?
The availability of tumor necrosis factor alpha (TNF-α) inhibitors as therapeutic options has revolutionized the treatment of psoriatic arthritis (PsA). The TNF-α inhibitors have set a high clinical standard (e.g., excellent efficacy in both peripheral and axial PsA, low risk of organ toxicity) that is challenging for emerging therapies to surpass. However, unmet needs exist for improvements in various efficacy, safety and tolerability, and delivery attributes. Several therapies, including those that will offer improvements over the TNF-α inhibitors on delivery or safety have either recently launched, or are in late-stage development. However, within this landscape, significant opportunity exists for new drugs that offer improved efficacy over that of the TNF-α inhibitors.
Questions Answered in This Report:
- Reduction in signs and symptoms of peripheral and axial disease, inhibition of structural damage, and skin clearance are key goals in the treatment of PsA. 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 PsA?
- AbbVie/Eisai’s adalimumab (Humira) is the 2013 major-market sales leader for PsA. What weaknesses exist in this drug’s profile that would allow emerging therapies to gain traction in the market? Have emerging therapies demonstrated strengths on the attributes that surveyed rheumatologists indicate are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed MCO PDs seek from new therapies?
- By 2018, secukinumab (Novartis’s Cosentyx) will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is secukinumab most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by secukinumab?
Attributes included in conjoint analysis-based assessment of target product profiles for PsA:
- Effect on peripheral disease—ACR 20 response at 6 months (% of patients, placebo-adjusted).
- Effect on axial disease—ASAS 20 response at 6 months (% of patients, placebo-adjusted).
- Effect on skin—PASI 75 response at 6 months (% of patients, placebo-adjusted).
- Liver toxicity—placebo-adjusted % of patients with alanine transaminase >3x upper level of normal.
- Rate of serious infections (per 100 patient-years, placebo-adjusted).
- Delivery burden (drug formulation and dosing).
Attributes included in assessment of U.S. payers’ receptivity to new therapies for PsA:
- Improved effect on signs and symptoms of arthritis (ACR 20 response at 6 months).
- Improved effect on skin (PASI 75 response at 6 months).
- Lower rate of serious infections (per 100 patient-years, placebo-adjusted).
- Improved formulation and dosing frequency.
Physicians surveyed: 60 U.S. and 30 European rheumatologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Adalimumab (AbbVie/Eisai’s Humira)
- Etanercept (Amgen/Pfizer/Takeda Pharmaceutical’s Enbrel)
- Infliximab (Janssen Biotech, Merck/Mitsubishi Tanabe Pharma’s Remicade)
- Ustekinumab (Janssen Biotech’s Stelara)
- Certolizumab pegol (UCB/Astellas Pharma’s Cimzia)
- Apremilast (Celgene’s Otezla)
- Secukinumab (Novartis’s Cosentyx)
- Abatacept (Bristol-Myers Squibb/Ono Pharmaceutical’s Orencia)
- Tofacitinib (Pfizer/Takeda Pharmaceutical’s Xeljanz)
- Brodalumab (Amgen/AstraZeneca)