Background/Purpose:
Secretagogues are commonly used to treat xerostomia in primary Sjogren’s syndrome (pSS). Side effects and/or lack of efficacy sometimes result in cessation of therapy. Our aim was to determine clinical and laboratory predictors associated with therapeutic failures.
Methods:
We retrospectively reviewed use of the secretagogues, pilocarpine (PC) and cevimeline (CV), in patients with pSS who fulfilled the 2002 American European Consensus Group criteria; followed from January 2002 to June 2012. Individuals with inadequate follow up (less than two visits) were excluded. Baseline variables included age, sex, duration of xerostomia, anti Ro (SSA) and anti La (SSB) antibodies, rheumatoid factor, antinuclear antibodies (ANA), complement levels, beta 2 microglobulin, serum protein electrophoresis, smoking history, unstimulated salivary flow rate, scintigraphy scores, focus score on lip biopsy, and previous use of hydroxychloroquine. Failure of therapy was defined as the clinician or patient’s decision to stop treatment either due to lack of efficacy or side effects.
Results:
Among 118 patients with pSS (92.4% female, mean age 61.4 years), PC was used in 72 (59 first users, 13 second users) and CV in 91 (59 first users, 32 second users). Cevimeline was associated with lower failure rates among all users (29/91, 31.9%) than PC (44/72, 61.1%) (p<0.001). Among first-time users, CV was also associated with lower failure rates (16/59, 27.1%) versus PC (28/59, 47.5%). (p=0.02). Severe sweating was the most frequent side effect leading to cessation of therapy and occurred more frequently among patients using PC (18/72, 25%) than CV (10/91, 11%) (p=0.02). Patients who previously failed one secretagogue were less likely to discontinue treatment with the other agent: i.e. 61/118 (51.7%) of first-time users compared to 12/45 (26.7%) of second-time users (p= 0.004). Among all users, the proportion of subjects stopping medication for any documented side effect tended to be higher in the PC group (31/72, 43.1%) than CV group (23/91, 25.3%) (p=0.09). Among the various clinical and laboratory parameters studied; only ANA positivity was associated with therapeutic failure: 45/76 (59%) of ANA-positive patients vs. 15/40 (38%) of ANA-negative patients discontinued for any reason. (p=0.03)
Conclusion:
Our data suggests that patients with pSS who take secretagogues for xerostomia are more likely to continue cevimeline than pilocarpine long-term. This is primarily due to a lower incidence of severe sweating (the most common side effect of therapy). However, therapeutic failure of one secretagogue did not predict similar results with the other. Second time users may be more likely to continue long-term treatment due to the lack of effective therapeutic alternatives. Among various clinical and laboratory features of pSS, only ANA positivity was associated with a higher likelihood of treatment failure. Further studies are needed to confirm these observations.
Disclosure:
G. Noaiseh,
None;
J. Baker,
None;
F. B. Vivino,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/secretagogue-use-in-patients-with-primary-sjogrens-syndrome/