Incyte Corporation (NASDAQ:INCY) and Eli Lilly and Company (NYSE:LLY) announced new data analyses of two phase 3 trials, RA-BUILD and RA-BEAM, showing that baricitinib treatment resulted in improvements in rheumatoid arthritis (RA) symptoms across a diverse population of patients with RA regardless of age, body mass index (BMI) and previous treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Findings were presented today at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Washington DC, November 11-16, 2016.
“Multiple patient characteristics may impact the effectiveness of rheumatoid arthritis treatment,” said James McGill, M.D., distinguished medical fellow and global brand development leader, Lilly Bio-Medicines. “What these data showed is that regardless of a patient’s age, body mass index or previous experience with conventional synthetic DMARDs, treatment with baricitinib resulted in improvement in rheumatoid arthritis symptoms. This gives us tremendous hope for how this oral medication may work in a real-world setting, if approved.”
Key findings include:
- Results from a post-hoc analysis of the phase 3 RA-BUILD and RA-BEAM studies evaluating elderly patients found that age did not affect baricitinib’s efficacy as measured by ACR20, Health Assessment Questionnaire-Disability Index (HAQ-DI), Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) and Simplified Disease Activity Index (SDAI).
- At week 12, in the baricitinib 4 mg group, 67 percent of patients younger than 65 years and 68 percent of patients 65 years or older achieved an ACR20 response, meaning a 20 percent improvement across various aspects of RA. In the group that received placebo, 40 percent of patients younger than 65 years and 43 percent of patients 65 years or older achieved an ACR20 response.
- The percentage of patients reporting an adverse event (AE) was higher in patients 65 years or older. The overall rates of AEs, serious adverse events (SAEs), and serious infections were similar between patients treated with placebo and baricitinib in patients younger than 65 years and patients 65 years or older. Additional safety information regarding RA-BUILD and RA-BEAM are provided in the study description below.
- Results from a post-hoc analysis of the phase 3 RA-BUILD and RA-BEAM studies evaluating the effect of baseline BMI on the response to baricitinib in patients who had insufficient response to previous csDMARDs found that baricitinib improved clinical outcomes compared to placebo regardless of baseline BMI as measured by ACR20, ACR50, ACR70, DAS28-CRP, SDAI and Clinical Disease Activity Index (CDAI). The proportion of patients who reached low disease activity or remission, including progression in structural joint damage, improved compared to placebo across the different BMI groups.
- Proportion of patients in the low, middle and high BMI groups who achieved an ACR20 response were 68.4 percent, 68 percent and 64.7 percent, respectively. ACR50 and ACR70 responses (meaning a 50 percent and 70 percent improvement across various aspects of RA, respectively) were also improved compared to placebo across the BMI groups. As has been shown for other DMARDs, baricitinib treatment effect for patients with higher BMI was numerically smaller than for patients with lower BMI.
- Additional safety information regarding RA-BUILD and RA-BEAM are provided in the study description below.
- Results from a post-hoc analysis of the phase 3 RA-BUILD and RA-BEAM studies evaluating whether the number of previous csDMARD failures altered patients’ response to baricitinib found that baricitinib demonstrated improvement in RA symptoms irrespective of the number of previous csDMARDs used or the present use of oral corticosteroids as measured by ACR20, ACR50, ACR70, radiographic progression, SDAI and DAS28-ESR.
- At week 12, in the baricitinib 4 mg groups that previously used methotrexate alone, methotrexate + 1 csDMARD and methotrexate + ≥2 csDMARDs, 67.9 percent, 67.3 percent and 66.9 percent of patients achieved an ACR20 response, respectively. ACR50 responses were also similar across the groups (42.5 percent, 42.9 percent and 39.2 percent, respectively) and ACR70 responses were 21.4 percent, 19.5 percent and 13.3 percent respectively.
- The rates of SAEs and discontinuation due to AEs were comparable regardless of the number of csDMARDs used and corticosteroid use. Additional safety information regarding RA-BUILD and RA-BEAM are provided in the study description below.
“These data add to the breadth of evidence supporting baricitinib’s efficacy profile across a wide range of patient populations,” said Steven Stein, M.D., chief medical officer, Incyte Corporation. “If approved, we believe that baricitinib has the potential to become an effective once-daily oral treatment option for patients with rheumatoid arthritis who may not respond well to other treatments — age, BMI or previous csDMARDs use notwithstanding.”
The RA-BUILD study enrolled 684 patients with moderate-to-severe RA who previously had an inadequate response to, or were intolerant of, at least one csDMARD and had not received a biologic disease-modifying antirheumatic drug (bDMARD). Patients received either once-daily baricitinib (2 mg or 4 mg) or placebo, in addition to their background therapy.
In RA-BUILD, the incidence of SAEs with baricitinib treatment, including serious infections, was similar to placebo. There were no gastrointestinal perforations in the study. A single case of tuberculosis was reported in a patient receiving baricitinib. The most common adverse events observed were consistent with previous studies of baricitinib in RA. Discontinuation rates due to adverse events were similar between treatment groups.
The 52-week RA-BEAM study randomized 1,307 patients who had active, moderate-to-severe RA, despite ongoing treatment with methotrexate. Patients were randomized to once-daily placebo (n=488), once-daily baricitinib 4 mg (n=487) or biweekly adalimumab 40 mg (n=330). All patients received background methotrexate. At week 24, patients taking placebo were crossed over to the baricitinib treatment group.
In RA BEAM, compared to placebo, serious adverse events rates were similar for baricitinib and lower for adalimumab; serious infection rates were similar across groups. There were no cases of gastrointestinal perforations. One event of tuberculosis was reported in each of the baricitinib and adalimumab groups. The most common adverse events observed with baricitinib were nasopharyngitis and bronchitis. Discontinuations due to adverse events occurred with similar frequency across treatment groups. (Original Source)
Shares of Incyte are currently trading at $103.50, down $1.01 or -0.97%. INCY has a 1-year high of $118.49 and a 1-year low of $55. The stock’s 50-day moving average is $91.87 and its 200-day moving average is $82.76.
On the ratings front, Incyte has been the subject of a number of recent research reports. In a report issued on November 3, Credit Suisse analyst Alethia Young reiterated a Buy rating on INCY, with a price target of $100, which represents a slight downside potential from current levels. Separately, on November 2, Leerink Swann’s Michael Schmidt reiterated a Buy rating on the stock and has a price target of $101.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Alethia Young and Michael Schmidt have a yearly average loss of 3.4% and a return of 24.3% respectively. Young has a success rate of 38% and is ranked #3702 out of 4209 analysts, while Schmidt has a success rate of 68% and is ranked #21.
Overall, 11 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $110.25 which is 5.5% above where the stock closed last Friday.
Incyte Corp. is a biopharmaceutical company, which focuses on the discovery, development, development, formulation, manufacturing and commercialization of proprietary therapeutics to treat serious unmet medical needs, primarily in oncology. Its product, Jakafi, a JAK1 and JAK2 inhibitor, is currently approved in the U.S. for the treatment of intermediate or high-risk myelofibrosis and is in development as a potential treatment for other cancers.