- Indian Rheumatology association
Kavya Devi Nunna MD (General Medicine), DM (Rheumatology)
Consultant Rheumatologist
Anvitha Arthritis Centre, Vijayawada, Andhra Pradesh, India
Low uveitis rates in patients with axial spondyloarthritis treated with Bimekizumab: pooled results from phase 2b/3 trials.
Both tumour necrosis factor-alpha (TNF-α) and interleukin (IL)-17 are potential targets for uveitis in axial spondylarthritis (axSpA). With the conflicting data on IL-17A inhibitors in preventing uveitis, this large pooled data from phase 2b trial BE AGILE and phase 3 trials [BE MOBILE 1 in non-radiographic SpA(nr-axSpA) and BE MOBILE 2 in radiographic SpA(r-axSpA)] provided overview of uveitis incidence in axSpA treated with Bimekizumab (BKZ). BKZ selectively inhibits interleukin (IL)-17F in addition to IL-17A.
In the 16-week double-blind treatment period in phase 3 trials, BKZ 160mg 4th weekly lowered uveitis incidence than placebo [0.6% vs 4.6%; p=0.001] and events are further low in patients with prior history of uveitis (1.9% vs 20%). Exposure-adjusted incidence rate (EAIR) of uveitis was lower in BKZ than in placebo [1.8/100 PYs vs 15.4/100 PY; nominal p=0.001].
In the pooled data of 848 patients treated with BKZ, 2.9% (25/848) had uveitis event; EAIR of uveitis was 1.2/100 PYs which was low when compared to rates in placebo arms of certolizumab pegol in nr-axSpA (7.2/100PY) and etanercept in r-axSpA (19.3/100PY). Though no head-to-head trials, uveitis incidence in patients with a prior history of uveitis was lower with BKZ (4.6/100PY) than certolizumab (17.7/100PY) and adalimumab (28.9/100PY) in other trials.
Though this data presented results on a larger population with overall long-term exposure to treatment (2034.4 PYs), results are to be taken with caution as reporting of uveitis incidence was not the endpoint result but rather an adverse event reporting.
Immunogenicity, reactogenicity, and safety of two-dose adjuvanted herpes zoster subunit vaccine in patients with systemic lupus erythematosus in South Korea: a single-center, randomized, double-blind, placebo-controlled trial.
The risk of herpes zoster (HZ) is six-fold higher in lupus patients. The potential risk of infection with the live-attenuated vaccine in immunocompromised people and its reduced efficacy in the elderly against HZ (61%) and post-herpetic neuralgia (67%) prompted the introduction of adjuvanted subunit vaccine. This single-center experience was the first randomized study showing the immunogenicity and safety of sub-unit vaccines in lupus patients.
65 clinically stable lupus patients aged ≥ 19 years with ≥ 4 weeks of exposure to immunosuppressants were randomized in 4:1 ratio to receive HZ vaccine or placebo at 0 and 8 weeks.
At both 8 weeks after the first dose and 4 weeks after the second dose, the humoral immune response was significantly higher in the vaccine group (98% vs 0%; p<0·0001) and was similar to the general population (97.5%). Cell-mediated immune response was similar to placebo at 8 weeks after the first dose and higher at 4 weeks after the second dose (67% vs 18%; p=0.010) and the response rates are low compared to the general population (67% vs 93%).
Local and systemic reactogenicity were more common in the vaccine group as expected. No difference in clinical or serological lupus flares between the groups and no vaccine-induced herpes is reported supporting its safety.
Thus, this randomised controlled trial showed good immunogenicity of adjuvanted HZ subunit vaccine in lupus patients without major safety concerns. Larger clinical trials are warranted to study the vaccine responses in severe lupus patients, the persistence of vaccine response beyond 1 year, and the requirement of booster doses in immunocompromised patients to up gear cellular immunity for better vaccine efficacy in preventing HZ reactivation.
