Large real-world study of psoriasis and psoriatic arthritis
No increased risk for atrial fibrillation or major cardiovascular events was observed among patients with psoriasis or psoriatic arthritis treated with ustekinumab (Stelara) compared with patients receiving a tumor necrosis factor (TNF) inhibitor, analysis of claims data showed.
Among patients enrolled in Optum Clinformatics and Truven MarketScan from 2009 to 2015, the hazard ratio for incident atrial fibrillation was a nonsignificant 1.08 (95% CI 0.76-1.54) for ustekinumab use versus TNF inhibitor use, according to Seoyoung C. Kim, MD, ScD, of Brigham & Women's Hospital in Boston, and colleagues.
Moreover, there was no difference in risk between ustekinumab and TNF inhibitors for the composite endpoint of major adverse cardiovascular events, which included myocardial infarction, stroke, and coronary revascularization (HR 1.10, 95% CI 0.80-1.52), the researchers reported online in JAMA Dermatology.
"Given a high cardiovascular (CV) risk among patients with psoriasis and psoriatic arthritis, it is important to have more information with regard to potential effects of different treatment agents on CV risk," Kim told MedPage Today.
"As the number of treatment options for psoriasis and psoriatic arthritis have been rising over the past few decades, it is even more crucial to have high-quality evidence on comparative safety of different treatment options so physicians and patients can choose an agent based on the benefit-risk profile of each drug they are considering," she said.
Previous experience has suggested that TNF inhibitor treatment may help decrease the CV risk in inflammatory conditions such as psoriasis and psoriatic arthritis, but little is known about the effects of other biologics on CV complications.
Kim and colleagues therefore analyzed outcomes from the two large nationwide databases for individuals ages 18 and older with psoriasis or psoriatic arthritis, identifying 9,071 patients who initiated treatment with ustekinumab and 50,957 who started treatment with a TNF inhibitor. The study had no industry funding.
In general, patients who received ustekinumab were younger, more often had psoriatic arthritis, and had more exposure to other biologics. The two groups were similar in CV comorbidities and healthcare utilization, but the TNF inhibitor group used more medications such as nonsteroidal anti-inflammatory drugs and COX-2 inhibitors. Propensity scores were calculated to account for between-group differences.
During mean follow-up of 1.4 years, there were 60 incident cases of atrial fibrillation in ustekinumab users and 323 in TNF inhibitor users, for incidence rates of 5 (95% CI 3.8-6.5) and 4.7 (95% CI 4.2-5.2) per 1,000 person-years, respectively.
Similar results were seen when rates were estimated separately for the two databases. In the Optum cohort, the incidence rates for atrial fibrillation in the ustekinumab and TNF inhibitor groups were 5 (95% CI 3-7.9) and 4.1 (95% CI 3.2-5.1), respectively, while in the MarketScan cohort, the incidence rates were 5 (95% CI 3.7-6.7) and 4.9 (95% CI 4.3-5.5).
There were 74 cases of major adverse CV events in the ustekinumab group and 421 in the TNF inhibitor group, for overall incidence rates of 6.2 (95% CI 4.9-7.8) and 6.1 (95% CI 5.5-6.7) per 1,000 person-years, respectively.
In the Optum cohort, the incidence rates for major CV events in the ustekinumab and TNF inhibitor groups were 3.8 (95% CI 2.1-6.4) and 5.4 (95% CI 4.3-6.6) per 1,000 person-years, respectively, while in the MarketScan cohort, the rates were 7.2 (95% CI 5.5-9.1) and 6.3 (95% CI 5.7-7) per 1,000.
Subgroup analyses found that there were no differences in rates of atrial fibrillation or major CV events for patients older than age 60, for those with diabetes, or between men and women. For example, the adjusted hazard ratio for incident atrial fibrillation was 1.21 (95% CI 0.87-1.69) in men and 0.82 (95% CI 0.49-1.39) in women. However, "the comparative safety of these drugs needs to be further examined in subgroups of patients (e.g., older age, men vs women, presence of diabetes at baseline)," Kim said. In addition, "further investigations on potentially modifying treatment effects stratified by important risk factors may be warranted," she and her colleagues wrote.
In conclusion, "the current study provides CV safety data from an important head-to-head comparison (two of the most commonly used categories of biologic drugs for the conditions) in a real-world setting," she said.
Limitations of the study included its observational design and relatively short follow-up time.
The study was funded by the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women's Hospital.
The authors reported financial relationships with the National Heart, Lung, and Blood Institute, Merck, Bayer, Vertex, Novartis, Pfizer, Amgen, AbbVie, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly, Takeda, and Roche.
Source Reference: Lee M, et al "Association of ustekinumab vs TNF inhibitor therapy with risk of atrial fibrillation and cardiovascular events in patients with psoriasis or psoriatic arthritis" JAMA Dermatol 2019; doi:10.1001/jamadermatol.2019.0001.
Read the original article on Medpage Today: Stelara vs Anti-TNF: CV Risks Similar