Background/Purpose

Our aim was to evaluate (a) whether subjects with Raynaud’s phenomenon (RP) can predict RP attacks because if so, then this could have implications for new treatment approaches and (b) the impact of RP attacks on quality of life (QOL).

Methods

Subjects with RP were approached through international patient associations to participate in an online survey. The survey comprised 19 questions including demographic information and details of the RP. Subjects were asked to report their ability to predict (all on an ordinal scale) the occurrence of RP attacks (<20%, 21%-50%, 51%-70% and>70% of times), severity of attacks (very poorly, poorly, fairly well, well, and very well), and their ability to prevent/control RP attacks (very poor, poorly, fairly well, well and very well). Other questions related to medications, how well subjects felt they could control their RP, and the impact of RP on QOL.

Results

A total of 443 responses from subjects with self-reported RP (mean age 41 years, 91% female), from 15 countries were evaluable. 187 subjects (43%) had primary RP (PRP, as judged by self-report), 149 (34%) secondary RP (SRP) and 100 (23%) were not aware of the cause of their RP. 252 (58%) of subjects reported that they could predict at least 51% of RP attacks (66% of subjects with SRP vs. 56% PRP, p=0.03). 248 (57%) subjects reported that they could predict attack severity either ‘fairly well’ or better (64% of subjects with SRP vs. 58% PRP, p=0.16), with 43% predicting severity only poorly (30%) or very poorly (13%).

64% of all subjects reported either a ‘poor’ or ‘very poor’ ability to prevent or control RP attacks. 182 subjects (41%) reported current or previous use of medications for RP: 82% reported at least one currently used medication being tolerated, but only 16% at least one current medication being ‘effective’.

Most subjects (78%) reported making at least one life adjustment due to RP, more so in subjects with SRP compared with PRP (87% vs.71%, [P=0.001]). Patients reported the impact of their RP on QOL on a 0-10 scale, where 10 was the best imaginable: the mean QOL for all patients was 6.0 (SD 2.1 [range = 1-10]). PRP subjects’ current QOL was higher than SRP subjects (mean QOL 6.5 and 5.2 respectively, difference in means (95% CI): 1.21 (0.76 to 1.66) [P < 0.001]). When asked to imagine their QOL without RP, SRP subjects imagined a greater absolute improvement from their current QOL (2.3 vs. 3.3, difference in means -0.9 (-1.4 to -0.4) [P=0.0002]).

Conclusion

1.      Subjects ability to predict both the occurrence and severity of RP attacks is limited (almost half of patients could predict neither attacks nor their severity), and this must be taken into account when designing clinical trials of future novel, ‘PRN’ (as required) treatments.

2.      Only 16% of subjects currently on medication for RP reported that at least one current medication was ‘effective’, and most subjects reported a poor ability to prevent/control RP attacks, confirming an unmet need to develop new treatments.

3.      RP significantly impacts on QOL, especially in subjects with SRP but also in PRP.